Testing Early Treatment for Patients With High-Risk Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL), EVOLVE CLL/SLL Study

April 11, 2024 updated by: National Cancer Institute (NCI)

Randomized, Phase III Study of Early Intervention With Venetoclax and Obinutuzumab Versus Delayed Therapy With Venetoclax and Obinutuzumab in Newly Diagnosed Asymptomatic High-Risk Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL): EVOLVE CLL/SLL Study

This phase III trial compares early treatment with venetoclax and obinutuzumab versus delayed treatment with venetoclax and obinutuzumab in patients with newly diagnosed high-risk chronic lymphocytic leukemia or small lymphocytic lymphoma. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Starting treatment with the venetoclax and obinutuzumab early (before patients have symptoms) may have better outcomes for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma compared to starting treatment with the venetoclax and obinutuzumab after patients show symptoms.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. To evaluate whether early treatment with venetoclax and obinutuzumab (V-O) extends overall survival (OS) compared with delayed treatment with V-O in high-risk (Chronic Lymphocytic Leukemia [CLL] International Prognostic Indicator [CLL-IPI] >= 4 or complex cytogenetics), newly diagnosed asymptomatic CLL/small lymphocytic lymphoma (SLL) patients.

SECONDARY OBJECTIVES:

I. To compare overall response rates (complete response [CR] + partial response [PR]), CR rates, progression-free survival (PFS), and event-free survival (EFS) between arms.

II. To evaluate safety and tolerability of each arm. III. To compare time to second CLL-directed treatment (from randomization and from response) between arms.

IV. To compare relapse-free survival (RFS) and time to second objective disease progression (PFS2) between arms.

V. To compare the rates of Richter's transformation between arms. VI. To describe distribution of Cumulative Illness Rating Scale across the study, in each treatment arm, and to estimate the interaction between the scale and treatment arm and OS.

PATIENT-REPORTED OUTCOMES OBJECTIVES:

I. To assess the impact of early intervention with V-O versus delayed therapy with V-O in CLL patients in relation to Health-Related Quality of Life (HRQoL) using the Functional Assessment of Cancer Therapy (FACT)-Leukemia scale.

II. To assess the impact of the two treatment arms on the specific domains of the FACT-Leukemia, including physical, social, emotional, and functional well-being and leukemia-specific HRQoL.

TRANSLATIONAL MEDICINE OBJECTIVES (INTEGRATED):

I. To evaluate the prognostic association between OS and measurable residual disease (MRD) undetectable disease state at 15 months after treatment initiation, across and between treatment arms. (Primary) II. To describe the prognostic association between the endpoints RFS and OS and MRD undetectable disease state at all measured time points (cycle [C]7 day[D]1, C9D1, C12D1, and 15, 21, 27, 33, 39, 45, 51, 57, 63, 69, 75, 81, 87, 93, and 99 months after treatment initiation) using landmark analyses, across and between treatment arms. (Secondary) III. To evaluate the prognostic association of MRD undetectable disease state over time in each treatment arm with respect to OS and RFS using time-dependent covariate analyses. (Secondary) IV. To describe the proportion of variation in OS and RFS explained by MRD sampling schemes with the goal of providing information on how much additional variation in OS and RFS is explained by additional MRD sampling for future trial designs. (Secondary) V. To compare the rate of MRD undetectable disease state at 15 months after initiation of treatment between treatment arms. (Secondary) VI. To compare duration of MRD undetectable disease state between treatment arms. (Secondary) VII. To describe associations between pretreatment stimulated karyotype risk, p53 mutation, IGHV mutational analysis, fluorescence in situ hybridization (FISH) for del(13q), del(11q), trisomy 12, and del(17p), and beta-2-microglobulin levels and other biomarkers with OS, PFS, overall and complete response rates, achievement of MRD undetectable disease state, and Richter's transformation. (Secondary) VIII. To describe associations between clinical complete or partial response (by International Workshop on Chronic Lymphocytic Leukemia [IWCLL] 2018 criteria) and response as assessed by MRD status and CT scans at 15 months after treatment initiation. (Secondary)

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I (DELAYED V-O): Treatment begins once 2018 IWCLL indications are met. Patients receive obinutuzumab intravenously (IV) over 4 hours on days 1, 2, 8, and 15 of cycle 1 and on day 1 of cycles 2-6. Patients also receive venetoclax orally (PO) once daily (QD) on days 22-28 of cycle 1 and on days 1-28 of cycles 2-12. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, collection of blood samples, and bone marrow aspiration throughout the trial.

ARM II (EARLY V-O): Treatment begins as soon as eligibility criteria are met. Patients receive obinutuzumab IV over 4 hours on days 1, 2, 8, and 15 of cycle 1 and on day 1 of cycles 2-6. Patients also receive venetoclax PO QD on days 22-28 of cycle 1 and on days 1-28 of cycles 2-12. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, collection of blood samples, and bone marrow aspiration throughout the trial.

After completion of study treatment, patients are followed up for 10 years after registration.

Study Type

Interventional

Enrollment (Estimated)

247

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Recruiting
        • BCCA-Vancouver Cancer Centre
        • Contact:
          • Site Public Contact
          • Phone Number: 888-939-3333
        • Principal Investigator:
          • Alina S. Gerrie
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • Recruiting
        • CancerCare Manitoba
        • Contact:
        • Principal Investigator:
          • Versha Banerji
    • New Brunswick
      • Saint John, New Brunswick, Canada, E2L 4L2
        • Recruiting
        • Atlantic Health Sciences Corporation-Saint John Regional Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 506-648-6890
        • Principal Investigator:
          • Alfonso Rivera Duarte
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Recruiting
        • QEII Health Sciences Centre/Nova Scotia Health Authority
        • Contact:
          • Site Public Contact
          • Phone Number: 902-473-6000
        • Principal Investigator:
          • Katherine S. Robinson
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Recruiting
        • Ottawa Hospital and Cancer Center-General Campus
        • Contact:
          • Site Public Contact
          • Phone Number: 613-761-4395
        • Principal Investigator:
          • David A. Macdonald
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Recruiting
        • Jewish General Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 8248 514-340-8222
        • Principal Investigator:
          • Tanya Skamene
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
        • Recruiting
        • Allan Blair Cancer Centre
        • Contact:
          • Site Public Contact
          • Phone Number: 306-766-2213
        • Principal Investigator:
          • Abdulhakim Eswedi
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Active, not recruiting
        • University of Alabama at Birmingham Cancer Center
    • Alaska
      • Anchorage, Alaska, United States, 98508
        • Suspended
        • Anchorage Associates in Radiation Medicine
      • Anchorage, Alaska, United States, 99504
        • Suspended
        • Anchorage Radiation Therapy Center
      • Anchorage, Alaska, United States, 99508
        • Suspended
        • Alaska Breast Care and Surgery LLC
      • Anchorage, Alaska, United States, 99508
        • Suspended
        • Alaska Oncology and Hematology LLC
      • Anchorage, Alaska, United States, 99508
        • Suspended
        • Alaska Women's Cancer Care
      • Anchorage, Alaska, United States, 99508
        • Suspended
        • Anchorage Oncology Centre
      • Anchorage, Alaska, United States, 99508
        • Suspended
        • Katmai Oncology Group
      • Anchorage, Alaska, United States, 99508
        • Suspended
        • Providence Alaska Medical Center
      • Fairbanks, Alaska, United States, 99701
    • Arizona
      • Phoenix, Arizona, United States, 85004
        • Suspended
        • Cancer Center at Saint Joseph's
    • Arkansas
      • Fort Smith, Arkansas, United States, 72903
        • Suspended
        • Mercy Hospital Fort Smith
      • Hot Springs, Arkansas, United States, 71913
        • Suspended
        • CHI Saint Vincent Cancer Center Hot Springs
    • California
      • Anaheim, California, United States, 92806
        • Recruiting
        • Kaiser Permanente-Anaheim
        • Principal Investigator:
          • Ashraf R. Aziz
        • Contact:
      • Arroyo Grande, California, United States, 93420
        • Suspended
        • Mission Hope Medical Oncology - Arroyo Grande
      • Baldwin Park, California, United States, 91706
        • Recruiting
        • Kaiser Permanente-Baldwin Park
        • Principal Investigator:
          • Ashraf R. Aziz
        • Contact:
      • Bellflower, California, United States, 90706
        • Recruiting
        • Kaiser Permanente-Bellflower
        • Principal Investigator:
          • Ashraf R. Aziz
        • Contact:
      • Burbank, California, United States, 91505
        • Suspended
        • Providence Saint Joseph Medical Center/Disney Family Cancer Center
      • Cameron Park, California, United States, 95682
        • Recruiting
        • Marshall Cancer Center
        • Contact:
        • Principal Investigator:
          • Joseph M. Tuscano
      • Carmichael, California, United States, 95608
        • Recruiting
        • Mercy Cancer Center �� Carmichael
        • Principal Investigator:
          • Shahzad Siddique
        • Contact:
      • Carmichael, California, United States, 95608
        • Recruiting
        • Mercy San Juan Medical Center
        • Principal Investigator:
          • Shahzad Siddique
        • Contact:
      • Costa Mesa, California, United States, 92627
        • Recruiting
        • UC Irvine Health Cancer Center-Newport
        • Principal Investigator:
          • Catherine C. Coombs
        • Contact:
          • Site Public Contact
          • Phone Number: 877-827-8839
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Alexey V. Danilov
      • Elk Grove, California, United States, 95758
        • Recruiting
        • Mercy Cancer Center - Elk Grove
        • Principal Investigator:
          • Shahzad Siddique
        • Contact:
      • Fontana, California, United States, 92335
        • Recruiting
        • Kaiser Permanente-Fontana
        • Principal Investigator:
          • Ashraf R. Aziz
        • Contact:
      • Harbor City, California, United States, 90710
        • Recruiting
        • Kaiser Permanente - Harbor City
        • Principal Investigator:
          • Ashraf R. Aziz
        • Contact:
      • Huntington Beach, California, United States, 92648
        • Recruiting
        • City of Hope at Huntington Beach
        • Contact:
          • Site Public Contact
          • Phone Number: 877-467-3411
        • Principal Investigator:
          • Alexey V. Danilov
      • Irvine, California, United States, 92618
        • Recruiting
        • Kaiser Permanente-Irvine
        • Principal Investigator:
          • Ashraf R. Aziz
        • Contact:
      • Irvine, California, United States, 92618
        • Recruiting
        • City of Hope at Irvine Lennar
        • Contact:
          • Site Public Contact
          • Phone Number: 877-467-3411
        • Principal Investigator:
          • Alexey V. Danilov
      • Laguna Hills, California, United States, 92653
        • Recruiting
        • UCI Health Laguna Hills
        • Principal Investigator:
          • Catherine C. Coombs
        • Contact:
      • Lancaster, California, United States, 93534
        • Recruiting
        • City of Hope Antelope Valley
        • Contact:
        • Principal Investigator:
          • Alexey V. Danilov
      • Long Beach, California, United States, 90822
        • Active, not recruiting
        • Tibor Rubin VA Medical Center
      • Long Beach, California, United States, 90813
        • Recruiting
        • City of Hope at Long Beach Elm
        • Contact:
          • Site Public Contact
          • Phone Number: 877-467-3411
        • Principal Investigator:
          • Alexey V. Danilov
      • Los Angeles, California, United States, 90027
        • Recruiting
        • Kaiser Permanente Los Angeles Medical Center
        • Principal Investigator:
          • Ashraf R. Aziz
        • Contact:
      • Los Angeles, California, United States, 90034
        • Recruiting
        • Kaiser Permanente West Los Angeles
        • Principal Investigator:
          • Ashraf R. Aziz
        • Contact:
      • Marysville, California, United States, 95901
        • Recruiting
        • Fremont - Rideout Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 530-749-4400
        • Principal Investigator:
          • Joseph M. Tuscano
      • Newport Beach, California, United States, 92660
        • Recruiting
        • City of Hope Newport Beach
        • Contact:
          • Site Public Contact
          • Phone Number: 877-467-3411
        • Principal Investigator:
          • Alexey V. Danilov
      • Ontario, California, United States, 91761
        • Recruiting
        • Kaiser Permanente-Ontario
        • Principal Investigator:
          • Ashraf R. Aziz
        • Contact:
      • Orange, California, United States, 92868
        • Recruiting
        • UC Irvine Health/Chao Family Comprehensive Cancer Center
        • Principal Investigator:
          • Catherine C. Coombs
        • Contact:
      • Palo Alto, California, United States, 94304
        • Active, not recruiting
        • Stanford Cancer Institute Palo Alto
      • Panorama City, California, United States, 91402
        • Recruiting
        • Kaiser Permanente - Panorama City
        • Principal Investigator:
          • Ashraf R. Aziz
        • Contact:
      • Riverside, California, United States, 92505
        • Recruiting
        • Kaiser Permanente-Riverside
        • Principal Investigator:
          • Ashraf R. Aziz
        • Contact:
      • Rocklin, California, United States, 95765
        • Recruiting
        • Mercy Cancer Center - Rocklin
        • Principal Investigator:
          • Shahzad Siddique
        • Contact:
      • Sacramento, California, United States, 95817
        • Recruiting
        • University of California Davis Comprehensive Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 916-734-3089
        • Principal Investigator:
          • Joseph M. Tuscano
      • Sacramento, California, United States, 95816
        • Recruiting
        • Mercy Cancer Center - Sacramento
        • Principal Investigator:
          • Shahzad Siddique
        • Contact:
      • San Diego, California, United States, 92120
        • Recruiting
        • Kaiser Permanente-San Diego Zion
        • Principal Investigator:
          • Ashraf R. Aziz
        • Contact:
      • San Luis Obispo, California, United States, 93401
        • Suspended
        • Pacific Central Coast Health Center-San Luis Obispo
      • San Marcos, California, United States, 92078
        • Recruiting
        • Kaiser Permanente-San Marcos
        • Principal Investigator:
          • Ashraf R. Aziz
        • Contact:
      • Santa Maria, California, United States, 93444
        • Suspended
        • Mission Hope Medical Oncology - Santa Maria
      • South Pasadena, California, United States, 91030
        • Recruiting
        • City of Hope South Pasadena
        • Contact:
        • Principal Investigator:
          • Alexey V. Danilov
      • Torrance, California, United States, 90503
        • Recruiting
        • City of Hope South Bay
        • Contact:
          • Site Public Contact
          • Phone Number: 877-467-3411
        • Principal Investigator:
          • Alexey V. Danilov
      • Upland, California, United States, 91786
        • Recruiting
        • City of Hope Upland
        • Contact:
        • Principal Investigator:
          • Alexey V. Danilov
      • Woodland, California, United States, 95695
        • Recruiting
        • Woodland Memorial Hospital
        • Principal Investigator:
          • Shahzad Siddique
        • Contact:
      • Woodland Hills, California, United States, 91367
        • Recruiting
        • Kaiser Permanente-Woodland Hills
        • Principal Investigator:
          • Ashraf R. Aziz
        • Contact:
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Suspended
        • The Medical Center of Aurora
      • Aurora, Colorado, United States, 80012
        • Recruiting
        • Rocky Mountain Cancer Centers-Aurora
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
      • Boulder, Colorado, United States, 80303
        • Suspended
        • Boulder Community Foothills Hospital
      • Boulder, Colorado, United States, 80304
        • Recruiting
        • Rocky Mountain Cancer Centers-Boulder
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
      • Centennial, Colorado, United States, 80112
        • Recruiting
        • Rocky Mountain Cancer Centers - Centennial
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
      • Colorado Springs, Colorado, United States, 80907
        • Suspended
        • Penrose-Saint Francis Healthcare
      • Colorado Springs, Colorado, United States, 80907
        • Suspended
        • Rocky Mountain Cancer Centers-Penrose
      • Denver, Colorado, United States, 80210
        • Suspended
        • Porter Adventist Hospital
      • Denver, Colorado, United States, 80218
        • Suspended
        • Presbyterian - Saint Lukes Medical Center - Health One
      • Denver, Colorado, United States, 80218
        • Suspended
        • SCL Health Saint Joseph Hospital
      • Denver, Colorado, United States, 80220
        • Suspended
        • Rose Medical Center
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Colorado Blood Cancer Institute
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
      • Denver, Colorado, United States, 80204
        • Suspended
        • Cancer Center of Colorado at Sloan's Lake
      • Denver, Colorado, United States, 80209
        • Suspended
        • The Women's Imaging Center
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Rocky Mountain Cancer Centers-Midtown
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
      • Denver, Colorado, United States, 80220
        • Recruiting
        • Rocky Mountain Cancer Centers-Rose
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
      • Denver, Colorado, United States, 80220
        • Suspended
        • Western Surgical Care
      • Denver, Colorado, United States, 80206
        • Suspended
        • National Jewish Health-Main Campus
      • Durango, Colorado, United States, 81301
        • Suspended
        • Mercy Medical Center
      • Durango, Colorado, United States, 81301
        • Suspended
        • Southwest Oncology PC
      • Englewood, Colorado, United States, 80113
        • Recruiting
        • Rocky Mountain Cancer Centers - Swedish
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
      • Englewood, Colorado, United States, 80113
        • Suspended
        • The Melanoma and Skin Cancer Institute
      • Englewood, Colorado, United States, 80113
        • Suspended
        • Swedish Medical Center
      • Englewood, Colorado, United States, 80113
        • Suspended
        • Mountain Blue Cancer Care Center - Swedish
      • Golden, Colorado, United States, 80401
        • Suspended
        • National Jewish Health-Western Hematology Oncology
      • Grand Junction, Colorado, United States, 81501
        • Suspended
        • Saint Mary's Hospital and Regional Medical Center
      • Grand Junction, Colorado, United States, 81505
        • Recruiting
        • Grand Valley Oncology
        • Contact:
        • Principal Investigator:
          • Jonathan D. King
      • Greeley, Colorado, United States, 80631
        • Suspended
        • North Colorado Medical Center
      • Lafayette, Colorado, United States, 80026
        • Suspended
        • Good Samaritan Medical Center
      • Lakewood, Colorado, United States, 80228
        • Suspended
        • Saint Anthony Hospital
      • Lakewood, Colorado, United States, 80228
        • Suspended
        • Rocky Mountain Cancer Centers-Lakewood
      • Littleton, Colorado, United States, 80120
        • Recruiting
        • Rocky Mountain Cancer Centers-Littleton
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
      • Littleton, Colorado, United States, 80122
        • Suspended
        • Littleton Adventist Hospital
      • Lone Tree, Colorado, United States, 80124
        • Suspended
        • Sky Ridge Medical Center
      • Lone Tree, Colorado, United States, 80124
        • Recruiting
        • Rocky Mountain Cancer Centers-Sky Ridge
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
      • Longmont, Colorado, United States, 80501
        • Suspended
        • Longmont United Hospital
      • Longmont, Colorado, United States, 80501
        • Suspended
        • Rocky Mountain Cancer Centers-Longmont
      • Loveland, Colorado, United States, 80539
        • Suspended
        • McKee Medical Center
      • Parker, Colorado, United States, 80138
        • Suspended
        • Parker Adventist Hospital
      • Pueblo, Colorado, United States, 81004
        • Suspended
        • Saint Mary Corwin Medical Center
      • Thornton, Colorado, United States, 80260
        • Suspended
        • Rocky Mountain Cancer Centers-Thornton
      • Thornton, Colorado, United States, 80260
        • Suspended
        • National Jewish Health-Northern Hematology Oncology
    • Delaware
      • Frankford, Delaware, United States, 19945
        • Recruiting
        • Beebe South Coastal Health Campus
        • Contact:
        • Principal Investigator:
          • Gregory A. Masters
      • Lewes, Delaware, United States, 19958
        • Suspended
        • Beebe Medical Center
      • Newark, Delaware, United States, 19713
        • Recruiting
        • Helen F Graham Cancer Center
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
      • Newark, Delaware, United States, 19713
        • Suspended
        • Delaware Clinical and Laboratory Physicians PA
      • Newark, Delaware, United States, 19713
        • Recruiting
        • Medical Oncology Hematology Consultants PA
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
      • Newark, Delaware, United States, 19718
        • Suspended
        • Christiana Care Health System-Christiana Hospital
      • Rehoboth Beach, Delaware, United States, 19971
        • Recruiting
        • Beebe Health Campus
        • Contact:
        • Principal Investigator:
          • Gregory A. Masters
      • Seaford, Delaware, United States, 19973
        • Suspended
        • TidalHealth Nanticoke / Allen Cancer Center
      • Wilmington, Delaware, United States, 19801
        • Suspended
        • Christiana Care Health System-Wilmington Hospital
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Recruiting
        • MedStar Georgetown University Hospital
        • Principal Investigator:
          • Joseph L. Roswarski
        • Contact:
          • Site Public Contact
          • Phone Number: 202-444-2223
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Recruiting
        • Holy Cross Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 954-267-7748
        • Principal Investigator:
          • Elie G. Dib
      • Pensacola, Florida, United States, 32504
        • Recruiting
        • Sacred Heart Hospital
        • Contact:
        • Principal Investigator:
          • Yazan Alsayed
    • Idaho
      • Boise, Idaho, United States, 83706
        • Recruiting
        • Saint Alphonsus Cancer Care Center-Boise
        • Contact:
        • Principal Investigator:
          • John M. Schallenkamp
      • Boise, Idaho, United States, 83712
        • Suspended
        • Saint Luke's Cancer Institute - Boise
      • Caldwell, Idaho, United States, 83605
        • Recruiting
        • Saint Alphonsus Cancer Care Center-Caldwell
        • Contact:
        • Principal Investigator:
          • John M. Schallenkamp
      • Coeur d'Alene, Idaho, United States, 83814
        • Recruiting
        • Kootenai Health - Coeur d'Alene
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Emmett, Idaho, United States, 83617
        • Suspended
        • Walter Knox Memorial Hospital
      • Fruitland, Idaho, United States, 83619
        • Suspended
        • Saint Luke's Cancer Institute - Fruitland
      • Meridian, Idaho, United States, 83642
        • Suspended
        • Idaho Urologic Institute-Meridian
      • Meridian, Idaho, United States, 83642
        • Suspended
        • Saint Luke's Cancer Institute - Meridian
      • Nampa, Idaho, United States, 83686
        • Suspended
        • Saint Luke's Cancer Institute - Nampa
      • Nampa, Idaho, United States, 83687
        • Recruiting
        • Saint Alphonsus Cancer Care Center-Nampa
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Post Falls, Idaho, United States, 83854
        • Recruiting
        • Kootenai Clinic Cancer Services - Post Falls
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Sandpoint, Idaho, United States, 83864
        • Recruiting
        • Kootenai Cancer Clinic
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Twin Falls, Idaho, United States, 83301
        • Suspended
        • Saint Luke's Cancer Institute - Twin Falls
    • Illinois
      • Alton, Illinois, United States, 62002
        • Suspended
        • Saint Anthony's Health
      • Aurora, Illinois, United States, 60504
        • Recruiting
        • Rush - Copley Medical Center
        • Contact:
        • Principal Investigator:
          • Suparna Mantha
      • Bloomington, Illinois, United States, 61704
        • Active, not recruiting
        • Illinois CancerCare-Bloomington
      • Burr Ridge, Illinois, United States, 60527
        • Suspended
        • Loyola Center for Health at Burr Ridge
      • Canton, Illinois, United States, 61520
        • Active, not recruiting
        • Illinois CancerCare-Canton
      • Carbondale, Illinois, United States, 62902
        • Suspended
        • Memorial Hospital of Carbondale
      • Carterville, Illinois, United States, 62918
        • Suspended
        • SIH Cancer Institute
      • Carthage, Illinois, United States, 62321
        • Active, not recruiting
        • Illinois CancerCare-Carthage
      • Centralia, Illinois, United States, 62801
        • Suspended
        • Centralia Oncology Clinic
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Michael J. Thirman
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Contact:
        • Principal Investigator:
          • Shuo Ma
      • Danville, Illinois, United States, 61832
        • Recruiting
        • Carle at The Riverfront
        • Principal Investigator:
          • Suparna Mantha
        • Contact:
      • DeKalb, Illinois, United States, 60115
        • Recruiting
        • Northwestern Medicine Cancer Center Kishwaukee
        • Contact:
        • Principal Investigator:
          • Robert M. Eisner
      • Decatur, Illinois, United States, 62526
        • Recruiting
        • Cancer Care Specialists of Illinois - Decatur
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Decatur, Illinois, United States, 62526
        • Suspended
        • Decatur Memorial Hospital
      • Dixon, Illinois, United States, 61021
        • Active, not recruiting
        • Illinois CancerCare-Dixon
      • Effingham, Illinois, United States, 62401
        • Recruiting
        • Carle Physician Group-Effingham
        • Principal Investigator:
          • Suparna Mantha
        • Contact:
      • Effingham, Illinois, United States, 62401
        • Recruiting
        • Crossroads Cancer Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Elmhurst, Illinois, United States, 60126
        • Recruiting
        • Elmhurst Memorial Hospital
        • Principal Investigator:
          • Matthew Siegel
        • Contact:
      • Eureka, Illinois, United States, 61530
        • Active, not recruiting
        • Illinois CancerCare-Eureka
      • Evanston, Illinois, United States, 60201
        • Recruiting
        • NorthShore University HealthSystem-Evanston Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 847-570-2109
        • Principal Investigator:
          • David L. Grinblatt
      • Galesburg, Illinois, United States, 61401
        • Suspended
        • Western Illinois Cancer Treatment Center
      • Galesburg, Illinois, United States, 61401
        • Active, not recruiting
        • Illinois CancerCare-Galesburg
      • Geneva, Illinois, United States, 60134
        • Recruiting
        • Northwestern Medicine Cancer Center Delnor
        • Contact:
        • Principal Investigator:
          • Robert M. Eisner
      • Glenview, Illinois, United States, 60026
        • Recruiting
        • NorthShore University HealthSystem-Glenbrook Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 847-570-2109
        • Principal Investigator:
          • David L. Grinblatt
      • Harvey, Illinois, United States, 60426
        • Recruiting
        • Ingalls Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Kimberly R. Kruczek
      • Highland Park, Illinois, United States, 60035
        • Recruiting
        • NorthShore University HealthSystem-Highland Park Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 847-570-2109
        • Principal Investigator:
          • David L. Grinblatt
      • Homer Glen, Illinois, United States, 60491
        • Suspended
        • Loyola Medicine Homer Glen
      • Kewanee, Illinois, United States, 61443
        • Active, not recruiting
        • Illinois CancerCare-Kewanee Clinic
      • Lake Forest, Illinois, United States, 60045
        • Recruiting
        • Northwestern Medicine Lake Forest Hospital
        • Contact:
        • Principal Investigator:
          • Shuo Ma
      • Macomb, Illinois, United States, 61455
        • Active, not recruiting
        • Illinois CancerCare-Macomb
      • Mattoon, Illinois, United States, 61938
        • Recruiting
        • Carle Physician Group-Mattoon/Charleston
        • Principal Investigator:
          • Suparna Mantha
        • Contact:
      • Maywood, Illinois, United States, 60153
        • Recruiting
        • Loyola University Medical Center
        • Principal Investigator:
          • Patrick A. Hagen
        • Contact:
          • Site Public Contact
          • Phone Number: 708-226-4357
      • Melrose Park, Illinois, United States, 60160
        • Suspended
        • Marjorie Weinberg Cancer Center at Loyola-Gottlieb
      • Mount Vernon, Illinois, United States, 62864
        • Recruiting
        • Good Samaritan Regional Health Center
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 618-242-4600
      • Naperville, Illinois, United States, 60540
        • Recruiting
        • Edward Hospital/Cancer Center
        • Principal Investigator:
          • Matthew Siegel
        • Contact:
          • Site Public Contact
          • Phone Number: 630-646-6075
      • New Lenox, Illinois, United States, 60451
        • Recruiting
        • UC Comprehensive Cancer Center at Silver Cross
        • Contact:
        • Principal Investigator:
          • Michael J. Thirman
      • O'Fallon, Illinois, United States, 62269
        • Recruiting
        • Cancer Care Center of O'Fallon
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Orland Park, Illinois, United States, 60462
        • Recruiting
        • University of Chicago Medicine-Orland Park
        • Contact:
        • Principal Investigator:
          • Michael J. Thirman
      • Ottawa, Illinois, United States, 61350
        • Active, not recruiting
        • Illinois CancerCare-Ottawa Clinic
      • Pekin, Illinois, United States, 61554
        • Active, not recruiting
        • Illinois CancerCare-Pekin
      • Peoria, Illinois, United States, 61636
        • Suspended
        • Methodist Medical Center of Illinois
      • Peoria, Illinois, United States, 61615
        • Active, not recruiting
        • Illinois CancerCare-Peoria
      • Peru, Illinois, United States, 61354
        • Suspended
        • Valley Radiation Oncology
      • Peru, Illinois, United States, 61354
        • Active, not recruiting
        • Illinois CancerCare-Peru
      • Plainfield, Illinois, United States, 60585
        • Recruiting
        • Edward Hospital/Cancer Center?Plainfield
        • Principal Investigator:
          • Matthew Siegel
        • Contact:
      • Princeton, Illinois, United States, 61356
        • Active, not recruiting
        • Illinois CancerCare-Princeton
      • Springfield, Illinois, United States, 62702
        • Recruiting
        • Southern Illinois University School of Medicine
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 217-545-7929
      • Springfield, Illinois, United States, 62702
        • Recruiting
        • Springfield Clinic
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 800-444-7541
      • Springfield, Illinois, United States, 62781
        • Suspended
        • Memorial Medical Center
      • Urbana, Illinois, United States, 61801
        • Recruiting
        • Carle Cancer Center
        • Principal Investigator:
          • Suparna Mantha
        • Contact:
      • Urbana, Illinois, United States, 61801
        • Suspended
        • The Carle Foundation Hospital
      • Warrenville, Illinois, United States, 60555
        • Recruiting
        • Northwestern Medicine Cancer Center Warrenville
        • Contact:
        • Principal Investigator:
          • Robert M. Eisner
      • Washington, Illinois, United States, 61571
        • Active, not recruiting
        • Illinois CancerCare - Washington
      • Yorkville, Illinois, United States, 60560
        • Recruiting
        • Rush-Copley Healthcare Center
        • Contact:
        • Principal Investigator:
          • Suparna Mantha
    • Indiana
      • Richmond, Indiana, United States, 47374
        • Recruiting
        • Reid Health
        • Contact:
        • Principal Investigator:
          • Howard M. Gross
    • Iowa
      • Ames, Iowa, United States, 50010
        • Recruiting
        • Mary Greeley Medical Center
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
          • Site Public Contact
          • Phone Number: 515-956-4132
      • Ames, Iowa, United States, 50010
        • Recruiting
        • McFarland Clinic - Ames
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
      • Ankeny, Iowa, United States, 50023
        • Recruiting
        • Mission Cancer and Blood - Ankeny
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
          • Site Public Contact
          • Phone Number: 515-282-2921
      • Boone, Iowa, United States, 50036
        • Recruiting
        • McFarland Clinic - Boone
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
          • Site Public Contact
          • Phone Number: 515-956-4132
      • Carroll, Iowa, United States, 51401
        • Suspended
        • Saint Anthony Regional Hospital
      • Cedar Rapids, Iowa, United States, 52402
        • Recruiting
        • Physicians' Clinic of Iowa PC
        • Contact:
          • Site Public Contact
          • Phone Number: 319-297-2900
        • Principal Investigator:
          • Bharat Jenigiri
      • Clive, Iowa, United States, 50325
        • Suspended
        • Medical Oncology and Hematology Associates-West Des Moines
      • Clive, Iowa, United States, 50325
        • Suspended
        • Mercy Cancer Center-West Lakes
      • Council Bluffs, Iowa, United States, 51503
        • Suspended
        • Alegent Health Mercy Hospital
      • Creston, Iowa, United States, 50801
        • Suspended
        • Greater Regional Medical Center
      • Des Moines, Iowa, United States, 50309
        • Recruiting
        • Medical Oncology and Hematology Associates-Des Moines
        • Principal Investigator:
          • Joshua Lukenbill
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
      • Des Moines, Iowa, United States, 50314
        • Recruiting
        • Broadlawns Medical Center
        • Principal Investigator:
          • Joshua Lukenbill
        • Contact:
          • Site Public Contact
          • Phone Number: 515-282-2200
      • Des Moines, Iowa, United States, 50314
        • Recruiting
        • Mercy Medical Center - Des Moines
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • Des Moines, Iowa, United States, 50316
        • Suspended
        • Iowa Lutheran Hospital
      • Des Moines, Iowa, United States, 50314
        • Suspended
        • Mission Cancer and Blood - Laurel
      • Des Moines, Iowa, United States, 50309
        • Recruiting
        • Iowa Methodist Medical Center
        • Principal Investigator:
          • Joshua Lukenbill
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-6727
      • Fort Dodge, Iowa, United States, 50501
        • Suspended
        • Trinity Regional Medical Center
      • Fort Dodge, Iowa, United States, 50501
        • Recruiting
        • McFarland Clinic - Trinity Cancer Center
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
          • Site Public Contact
          • Phone Number: 515-956-4132
      • Jefferson, Iowa, United States, 50129
        • Recruiting
        • McFarland Clinic - Jefferson
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
          • Site Public Contact
          • Phone Number: 515-956-4132
      • Marshalltown, Iowa, United States, 50158
        • Recruiting
        • McFarland Clinic - Marshalltown
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
          • Site Public Contact
          • Phone Number: 515-956-4132
      • West Des Moines, Iowa, United States, 50266-7700
        • Suspended
        • Methodist West Hospital
      • West Des Moines, Iowa, United States, 50266
        • Suspended
        • Mercy Medical Center-West Lakes
    • Kansas
      • Garden City, Kansas, United States, 67846
        • Suspended
        • Central Care Cancer Center - Garden City
      • Great Bend, Kansas, United States, 67530
        • Suspended
        • Central Care Cancer Center - Great Bend
    • Kentucky
      • Bardstown, Kentucky, United States, 40004
        • Suspended
        • Flaget Memorial Hospital
      • Corbin, Kentucky, United States, 40701
        • Suspended
        • Commonwealth Cancer Center-Corbin
      • Lexington, Kentucky, United States, 40504
        • Suspended
        • Saint Joseph Radiation Oncology Resource Center
      • Lexington, Kentucky, United States, 40509
        • Suspended
        • Saint Joseph Hospital East
      • London, Kentucky, United States, 40741
        • Suspended
        • Saint Joseph London
      • Louisville, Kentucky, United States, 40202
        • Suspended
        • Jewish Hospital
      • Louisville, Kentucky, United States, 40215
        • Suspended
        • Saints Mary and Elizabeth Hospital
      • Louisville, Kentucky, United States, 40245
        • Suspended
        • UofL Health Medical Center Northeast
      • Shepherdsville, Kentucky, United States, 40165
        • Suspended
        • Jewish Hospital Medical Center South
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Active, not recruiting
        • Hematology/Oncology Clinic PLLC
      • Monroe, Louisiana, United States, 71202
        • Active, not recruiting
        • Ochsner LSU Health Monroe Medical Center
      • New Orleans, Louisiana, United States, 70112
        • Active, not recruiting
        • Tulane University School of Medicine
      • Shreveport, Louisiana, United States, 71103
        • Active, not recruiting
        • LSU Health Sciences Center at Shreveport
      • Shreveport, Louisiana, United States, 71101
        • Active, not recruiting
        • Ochsner LSU Health Saint Mary's Medical Center
    • Maryland
      • Bethesda, Maryland, United States, 20889-5600
        • Recruiting
        • Walter Reed National Military Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 301-319-2100
        • Principal Investigator:
          • Christin Destefano
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana-Farber Cancer Institute
        • Principal Investigator:
          • Inhye E. Ahn
        • Contact:
          • Site Public Contact
          • Phone Number: 877-442-3324
      • Boston, Massachusetts, United States, 02111
    • Michigan
      • Adrian, Michigan, United States, 49221
        • Suspended
        • Hickman Cancer Center
      • Ann Arbor, Michigan, United States, 48106
      • Battle Creek, Michigan, United States, 49017
        • Recruiting
        • Bronson Battle Creek
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Brighton, Michigan, United States, 48114
      • Brighton, Michigan, United States, 48114
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology - Brighton
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Brownstown, Michigan, United States, 48183
        • Suspended
        • Henry Ford Cancer Institute-Downriver
      • Canton, Michigan, United States, 48188
      • Canton, Michigan, United States, 48188
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology - Canton
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Caro, Michigan, United States, 48723
        • Suspended
        • Caro Cancer Center
      • Chelsea, Michigan, United States, 48118
      • Chelsea, Michigan, United States, 48118
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Clarkston, Michigan, United States, 48346
      • Clarkston, Michigan, United States, 48346
      • Clinton Township, Michigan, United States, 48038
        • Suspended
        • Henry Ford Macomb Hospital-Clinton Township
      • Dearborn, Michigan, United States, 48126
        • Suspended
        • Henry Ford Medical Center-Fairlane
      • Detroit, Michigan, United States, 48236
        • Recruiting
        • Ascension Saint John Hospital
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital
        • Contact:
        • Principal Investigator:
          • Haythem Y. Ali
      • East China Township, Michigan, United States, 48054
        • Recruiting
        • Great Lakes Cancer Management Specialists-Doctors Park
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Flint, Michigan, United States, 48503
        • Recruiting
        • Genesee Cancer and Blood Disease Treatment Center
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Flint, Michigan, United States, 48503
        • Recruiting
        • Genesee Hematology Oncology PC
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Flint, Michigan, United States, 48503
        • Recruiting
        • Genesys Hurley Cancer Institute
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Flint, Michigan, United States, 48503
        • Recruiting
        • Hurley Medical Center
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Spectrum Health at Butterworth Campus
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Grand Rapids, Michigan, United States, 49503
        • Suspended
        • Helen DeVos Children's Hospital at Spectrum Health
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Trinity Health Grand Rapids Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Grosse Pointe Woods, Michigan, United States, 48236
        • Recruiting
        • Academic Hematology Oncology Specialists
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Grosse Pointe Woods, Michigan, United States, 48236
        • Recruiting
        • Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Grosse Pointe Woods, Michigan, United States, 48236
        • Suspended
        • Michigan Breast Specialists-Grosse Pointe Woods
      • Jackson, Michigan, United States, 49201
        • Suspended
        • Allegiance Health
      • Kalamazoo, Michigan, United States, 49007
        • Recruiting
        • Bronson Methodist Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Kalamazoo, Michigan, United States, 49007
        • Recruiting
        • West Michigan Cancer Center
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Kalamazoo, Michigan, United States, 49009
        • Recruiting
        • Ascension Borgess Cancer Center
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Kalamazoo, Michigan, United States, 49048
        • Suspended
        • Borgess Medical Center
      • Lansing, Michigan, United States, 48912
        • Recruiting
        • University of Michigan Health - Sparrow Lansing
        • Principal Investigator:
          • Elie G. Dib
        • Contact:
      • Livonia, Michigan, United States, 48154
        • Suspended
        • Hope Cancer Clinic
      • Livonia, Michigan, United States, 48154
        • Recruiting
        • Trinity Health Saint Mary Mercy Livonia Hospital
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Macomb, Michigan, United States, 48044
        • Recruiting
        • Great Lakes Cancer Management Specialists-Macomb Medical Campus
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Macomb, Michigan, United States, 48044
        • Suspended
        • Michigan Breast Specialists-Macomb Township
      • Marlette, Michigan, United States, 48453
        • Suspended
        • Saint Mary's Oncology/Hematology Associates of Marlette
      • Monroe, Michigan, United States, 48162
        • Suspended
        • Toledo Clinic Cancer Centers-Monroe
      • Muskegon, Michigan, United States, 49444
        • Recruiting
        • Trinity Health Muskegon Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Niles, Michigan, United States, 49120
        • Suspended
        • Corewell Health Lakeland Hospitals - Niles Hospital
      • Norton Shores, Michigan, United States, 49444
        • Recruiting
        • Cancer and Hematology Centers of Western Michigan - Norton Shores
        • Principal Investigator:
          • Kathleen J. Yost
        • Contact:
      • Novi, Michigan, United States, 48377
        • Suspended
        • Henry Ford Medical Center-Columbus
      • Pontiac, Michigan, United States, 48341
        • Recruiting
        • 21st Century Oncology-Pontiac
        • Principal Investigator:
          • Elie G. Dib
        • Contact:
      • Pontiac, Michigan, United States, 48341
      • Pontiac, Michigan, United States, 48341
      • Pontiac, Michigan, United States, 48341
        • Suspended
        • Hope Cancer Center
      • Reed City, Michigan, United States, 49677
        • Recruiting
        • Corewell Health Reed City Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Saginaw, Michigan, United States, 48601
        • Recruiting
        • Ascension Saint Mary's Hospital
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Saginaw, Michigan, United States, 48604
        • Recruiting
        • Oncology Hematology Associates of Saginaw Valley PC
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Saint Joseph, Michigan, United States, 49085
        • Suspended
        • Lakeland Medical Center Saint Joseph
      • Saint Joseph, Michigan, United States, 49085
        • Recruiting
        • Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Shelby, Michigan, United States, 48315
        • Suspended
        • Henry Ford Macomb Health Center - Shelby Township
      • Southfield, Michigan, United States, 48075
        • Recruiting
        • Ascension Providence Hospitals - Southfield
        • Contact:
        • Principal Investigator:
          • Adam M. Forman
      • Sterling Heights, Michigan, United States, 48312
        • Recruiting
        • Bhadresh Nayak MD PC-Sterling Heights
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Tawas City, Michigan, United States, 48764
        • Recruiting
        • Ascension Saint Joseph Hospital
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Traverse City, Michigan, United States, 49684
        • Recruiting
        • Munson Medical Center
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Warren, Michigan, United States, 48093
        • Recruiting
        • Great Lakes Cancer Management Specialists-Macomb Professional Building
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Warren, Michigan, United States, 48093
        • Recruiting
        • Macomb Hematology Oncology PC
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Warren, Michigan, United States, 48093
        • Recruiting
        • Saint John Macomb-Oakland Hospital
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Warren, Michigan, United States, 48088
        • Suspended
        • Advanced Breast Care Center PLLC
      • Warren, Michigan, United States, 48093
        • Suspended
        • Michigan Breast Specialists-Warren
      • West Bloomfield, Michigan, United States, 48322
        • Suspended
        • Henry Ford West Bloomfield Hospital
      • West Branch, Michigan, United States, 48661
        • Recruiting
        • Saint Mary's Oncology/Hematology Associates of West Branch
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Wyoming, Michigan, United States, 49519
        • Recruiting
        • University of Michigan Health - West
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Ypsilanti, Michigan, United States, 48106
      • Ypsilanti, Michigan, United States, 48197
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
    • Minnesota
      • Burnsville, Minnesota, United States, 55337
        • Suspended
        • Fairview Ridges Hospital
      • Burnsville, Minnesota, United States, 55337
        • Suspended
        • Minnesota Oncology - Burnsville
      • Cambridge, Minnesota, United States, 55008
        • Suspended
        • Cambridge Medical Center
      • Coon Rapids, Minnesota, United States, 55433
        • Recruiting
        • Mercy Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Duluth, Minnesota, United States, 55805
        • Recruiting
        • Essentia Health Cancer Center
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Edina, Minnesota, United States, 55435
        • Suspended
        • Fairview Southdale Hospital
      • Fridley, Minnesota, United States, 55432
        • Active, not recruiting
        • Unity Hospital
      • Hibbing, Minnesota, United States, 55746
        • Recruiting
        • Essentia Health Hibbing Clinic
        • Principal Investigator:
          • Bret E. Friday
        • Contact:
          • Site Public Contact
          • Phone Number: 218-786-3308
      • Maple Grove, Minnesota, United States, 55369
        • Suspended
        • Fairview Clinics and Surgery Center Maple Grove
      • Maplewood, Minnesota, United States, 55109
        • Recruiting
        • Saint John's Hospital - Healtheast
        • Contact:
        • Principal Investigator:
          • David M. King
      • Maplewood, Minnesota, United States, 55109
        • Suspended
        • Minnesota Oncology Hematology PA-Maplewood
      • Minneapolis, Minnesota, United States, 55407
        • Suspended
        • Abbott-Northwestern Hospital
      • Minneapolis, Minnesota, United States, 55415
        • Suspended
        • Hennepin County Medical Center
      • Minneapolis, Minnesota, United States, 55454
        • Suspended
        • Health Partners Inc
      • Minneapolis, Minnesota, United States, 55417
        • Recruiting
        • Minneapolis VA Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 612-467-2800
        • Principal Investigator:
          • Mark A. Klein
      • Monticello, Minnesota, United States, 55362
        • Suspended
        • Monticello Cancer Center
      • New Ulm, Minnesota, United States, 56073
        • Suspended
        • New Ulm Medical Center
      • Princeton, Minnesota, United States, 55371
        • Suspended
        • Fairview Northland Medical Center
      • Robbinsdale, Minnesota, United States, 55422
        • Suspended
        • North Memorial Medical Health Center
      • Saint Louis Park, Minnesota, United States, 55416
        • Recruiting
        • Park Nicollet Clinic - Saint Louis Park
        • Contact:
        • Principal Investigator:
          • David M. King
      • Saint Paul, Minnesota, United States, 55102
        • Suspended
        • United Hospital
      • Saint Paul, Minnesota, United States, 55101
        • Suspended
        • Regions Hospital
      • Shakopee, Minnesota, United States, 55379
        • Suspended
        • Saint Francis Regional Medical Center
      • Stillwater, Minnesota, United States, 55082
        • Suspended
        • Lakeview Hospital
      • Virginia, Minnesota, United States, 55792
        • Recruiting
        • Essentia Health Virginia Clinic
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Waconia, Minnesota, United States, 55387
        • Recruiting
        • Ridgeview Medical Center
        • Contact:
        • Principal Investigator:
          • David M. King
      • Willmar, Minnesota, United States, 56201
        • Suspended
        • Rice Memorial Hospital
      • Woodbury, Minnesota, United States, 55125
        • Suspended
        • Minnesota Oncology Hematology PA-Woodbury
      • Wyoming, Minnesota, United States, 55092
        • Suspended
        • Fairview Lakes Medical Center
    • Mississippi
      • Columbus, Mississippi, United States, 39705
        • Recruiting
        • Baptist Memorial Hospital and Cancer Center-Golden Triangle
        • Contact:
        • Principal Investigator:
          • Muhammad Raza
      • Grenada, Mississippi, United States, 38901
        • Recruiting
        • Baptist Cancer Center-Grenada
        • Contact:
        • Principal Investigator:
          • Muhammad Raza
      • New Albany, Mississippi, United States, 38652
        • Recruiting
        • Baptist Memorial Hospital and Cancer Center-Union County
        • Contact:
        • Principal Investigator:
          • Muhammad Raza
      • Southhaven, Mississippi, United States, 38671
        • Recruiting
        • Baptist Memorial Hospital and Cancer Center-Desoto
        • Contact:
        • Principal Investigator:
          • Muhammad Raza
    • Missouri
      • Ballwin, Missouri, United States, 63011
        • Suspended
        • Saint Louis Cancer and Breast Institute-Ballwin
      • Bolivar, Missouri, United States, 65613
        • Suspended
        • Central Care Cancer Center - Bolivar
      • Cape Girardeau, Missouri, United States, 63703
        • Recruiting
        • Saint Francis Medical Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 573-334-2230
          • Email: sfmc@sfmc.net
      • Cape Girardeau, Missouri, United States, 63703
        • Suspended
        • Southeast Cancer Center
      • Chesterfield, Missouri, United States, 63017
        • Recruiting
        • Saint Luke's Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 314-205-6936
        • Principal Investigator:
          • Joseph Sokhn
      • Creve Coeur, Missouri, United States, 63141
        • Active, not recruiting
        • Siteman Cancer Center at West County Hospital
      • Farmington, Missouri, United States, 63640
        • Recruiting
        • Parkland Health Center - Farmington
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Jefferson City, Missouri, United States, 65109
        • Suspended
        • Capital Region Southwest Campus
      • Joplin, Missouri, United States, 64804
        • Suspended
        • Freeman Health System
      • Joplin, Missouri, United States, 64804
        • Suspended
        • Mercy Hospital Joplin
      • Rolla, Missouri, United States, 65401
        • Suspended
        • Delbert Day Cancer Institute at PCRMC
      • Rolla, Missouri, United States, 65401
        • Suspended
        • Mercy Clinic-Rolla-Cancer and Hematology
      • Saint Joseph, Missouri, United States, 64506
        • Suspended
        • Heartland Regional Medical Center
      • Saint Louis, Missouri, United States, 63141
        • Recruiting
        • Mercy Hospital Saint Louis
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 314-251-7066
      • Saint Louis, Missouri, United States, 63131
        • Recruiting
        • Missouri Baptist Medical Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Saint Louis, Missouri, United States, 63109
        • Suspended
        • Saint Louis Cancer and Breast Institute-South City
      • Saint Louis, Missouri, United States, 63128
        • Recruiting
        • Mercy Hospital South
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Saint Louis, Missouri, United States, 63110
        • Active, not recruiting
        • Washington University School of Medicine
      • Saint Louis, Missouri, United States, 63129
        • Active, not recruiting
        • Siteman Cancer Center-South County
      • Saint Louis, Missouri, United States, 63136
        • Active, not recruiting
        • Siteman Cancer Center at Christian Hospital
      • Saint Peters, Missouri, United States, 63376
        • Active, not recruiting
        • Siteman Cancer Center at Saint Peters Hospital
      • Sainte Genevieve, Missouri, United States, 63670
        • Recruiting
        • Sainte Genevieve County Memorial Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Springfield, Missouri, United States, 65804
        • Suspended
        • Mercy Hospital Springfield
      • Springfield, Missouri, United States, 65807
        • Suspended
        • CoxHealth South Hospital
      • Sullivan, Missouri, United States, 63080
        • Recruiting
        • Missouri Baptist Sullivan Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Sunset Hills, Missouri, United States, 63127
        • Recruiting
        • BJC Outpatient Center at Sunset Hills
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Washington, Missouri, United States, 63090
        • Suspended
        • Mercy Hospital Washington
    • Montana
      • Anaconda, Montana, United States, 59711
        • Recruiting
        • Community Hospital of Anaconda
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Billings, Montana, United States, 59101
        • Recruiting
        • Billings Clinic Cancer Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Billings, Montana, United States, 59101
        • Suspended
        • Saint Vincent Healthcare
      • Billings, Montana, United States, 59102
        • Suspended
        • Saint Vincent Frontier Cancer Center
      • Bozeman, Montana, United States, 59715
        • Recruiting
        • Bozeman Deaconess Hospital
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Great Falls, Montana, United States, 59405
        • Recruiting
        • Benefis Healthcare- Sletten Cancer Institute
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Great Falls, Montana, United States, 59405
        • Suspended
        • Great Falls Clinic
      • Kalispell, Montana, United States, 59901
        • Recruiting
        • Kalispell Regional Medical Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Missoula, Montana, United States, 59802
        • Suspended
        • Saint Patrick Hospital - Community Hospital
      • Missoula, Montana, United States, 59804
        • Recruiting
        • Community Medical Hospital
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
    • Nebraska
      • Grand Island, Nebraska, United States, 68803
        • Suspended
        • CHI Health Saint Francis
      • Kearney, Nebraska, United States, 68847
        • Suspended
        • CHI Health Good Samaritan
      • Lincoln, Nebraska, United States, 68510
        • Suspended
        • Saint Elizabeth Regional Medical Center
      • Lincoln, Nebraska, United States, 68516
        • Recruiting
        • Cancer Partners of Nebraska - Pine Lake
        • Contact:
        • Principal Investigator:
          • Joni A. Tilford
      • Lincoln, Nebraska, United States, 68516
        • Recruiting
        • Southeast Nebraska Cancer Center - 68th Street Place
        • Contact:
        • Principal Investigator:
          • Joni A. Tilford
      • Omaha, Nebraska, United States, 68122
        • Suspended
        • Alegent Health Immanuel Medical Center
      • Omaha, Nebraska, United States, 68124
        • Suspended
        • Alegent Health Bergan Mercy Medical Center
      • Omaha, Nebraska, United States, 68130
        • Suspended
        • Alegent Health Lakeside Hospital
      • Omaha, Nebraska, United States, 68131
        • Suspended
        • Creighton University Medical Center
      • Papillion, Nebraska, United States, 68046
        • Suspended
        • Midlands Community Hospital
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Recruiting
        • OptumCare Cancer Care at Charleston
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89148
        • Recruiting
        • OptumCare Cancer Care at Fort Apache
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Recruiting
        • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
        • Contact:
        • Principal Investigator:
          • Frederick Lansigan
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Recruiting
        • Memorial Sloan Kettering Basking Ridge
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Lindsey E. Roeker
      • Camden, New Jersey, United States, 08103
        • Recruiting
        • Cooper Hospital University Medical Center
        • Principal Investigator:
          • Tulin Budak-Alpdogan
        • Contact:
          • Site Public Contact
          • Phone Number: 856-325-6757
      • Jersey City, New Jersey, United States, 07302
        • Recruiting
        • Jersey City Medical Center
        • Principal Investigator:
          • Joanna M. Rhodes
        • Contact:
      • Lakewood, New Jersey, United States, 08701
        • Recruiting
        • Monmouth Medical Center Southern Campus
        • Principal Investigator:
          • Joanna M. Rhodes
        • Contact:
      • Long Branch, New Jersey, United States, 07740
        • Recruiting
        • Monmouth Medical Center
        • Principal Investigator:
          • Joanna M. Rhodes
        • Contact:
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • Memorial Sloan Kettering Monmouth
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Lindsey E. Roeker
      • Montvale, New Jersey, United States, 07645
        • Recruiting
        • Memorial Sloan Kettering Bergen
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Lindsey E. Roeker
      • New Brunswick, New Jersey, United States, 08903
        • Recruiting
        • Rutgers Cancer Institute of New Jersey
        • Principal Investigator:
          • Joanna M. Rhodes
        • Contact:
          • Site Public Contact
          • Phone Number: 732-235-7356
      • Toms River, New Jersey, United States, 08755
        • Recruiting
        • Community Medical Center
        • Principal Investigator:
          • Joanna M. Rhodes
        • Contact:
      • Voorhees, New Jersey, United States, 08043
        • Recruiting
        • MD Anderson Cancer Center at Cooper-Voorhees
        • Principal Investigator:
          • Tulin Budak-Alpdogan
        • Contact:
          • Site Public Contact
          • Phone Number: 856-325-6757
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Recruiting
        • University of New Mexico Cancer Center
        • Contact:
        • Principal Investigator:
          • Leslie A. Andritsos
      • Albuquerque, New Mexico, United States, 87110
        • Recruiting
        • Presbyterian Kaseman Hospital
        • Contact:
        • Principal Investigator:
          • Leslie A. Andritsos
      • Las Cruces, New Mexico, United States, 88011
        • Recruiting
        • Memorial Medical Center - Las Cruces
        • Contact:
        • Principal Investigator:
          • Leslie A. Andritsos
      • Rio Rancho, New Mexico, United States, 87124
        • Recruiting
        • Presbyterian Rust Medical Center/Jorgensen Cancer Center
        • Contact:
        • Principal Investigator:
          • Leslie A. Andritsos
    • New York
      • Auburn, New York, United States, 13021
        • Suspended
        • Hematology Oncology Associates of Central New York-Auburn
      • Commack, New York, United States, 11725
        • Recruiting
        • Memorial Sloan Kettering Commack
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Lindsey E. Roeker
      • East Syracuse, New York, United States, 13057
        • Recruiting
        • Hematology Oncology Associates of Central New York-East Syracuse
        • Contact:
          • Site Public Contact
          • Phone Number: 315-472-7504
        • Principal Investigator:
          • Steven M. Duffy
      • Glens Falls, New York, United States, 12801
        • Recruiting
        • Glens Falls Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 518-926-6700
        • Principal Investigator:
          • Christopher R. Mason
      • Harrison, New York, United States, 10604
        • Recruiting
        • Memorial Sloan Kettering Westchester
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Lindsey E. Roeker
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Lindsey E. Roeker
      • New York, New York, United States, 10029
        • Active, not recruiting
        • Mount Sinai Hospital
      • Oswego, New York, United States, 13126
        • Recruiting
        • Upstate Cancer Center at Oswego
        • Contact:
        • Principal Investigator:
          • Krishna Ghimire
      • Rochester, New York, United States, 14642
        • Recruiting
        • University of Rochester
        • Contact:
          • Site Public Contact
          • Phone Number: 585-275-5830
        • Principal Investigator:
          • Paul M. Barr
      • Rochester, New York, United States, 14621
        • Active, not recruiting
        • Rochester General Hospital
      • Syracuse, New York, United States, 13210
        • Recruiting
        • State University of New York Upstate Medical University
        • Contact:
          • Site Public Contact
          • Phone Number: 315-464-5476
        • Principal Investigator:
          • Krishna Ghimire
      • Syracuse, New York, United States, 13215
        • Recruiting
        • Hematology Oncology Associates of Central New York-Onondaga Hill
        • Contact:
          • Site Public Contact
          • Phone Number: 315-472-7504
        • Principal Investigator:
          • Steven M. Duffy
      • Syracuse, New York, United States, 13215
        • Recruiting
        • SUNY Upstate Medical Center-Community Campus
        • Contact:
          • Site Public Contact
          • Phone Number: 315-464-5476
        • Principal Investigator:
          • Krishna Ghimire
      • Uniondale, New York, United States, 11553
        • Recruiting
        • Memorial Sloan Kettering Nassau
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Lindsey E. Roeker
      • Verona, New York, United States, 13478
        • Recruiting
        • Upstate Cancer Center at Verona
        • Contact:
        • Principal Investigator:
          • Krishna Ghimire
      • Webster, New York, United States, 14580
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • UNC Lineberger Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Christopher E. Jensen
      • Clinton, North Carolina, United States, 28328
        • Recruiting
        • Southeastern Medical Oncology Center-Clinton
        • Contact:
        • Principal Investigator:
          • Samer S. Kasbari
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 888-275-3853
        • Principal Investigator:
          • Danielle M. Brander
      • Durham, North Carolina, United States, 27705
        • Recruiting
        • Durham VA Medical Center
        • Contact:
        • Principal Investigator:
          • Thomas D. Rodgers
      • Goldsboro, North Carolina, United States, 27534
        • Recruiting
        • Southeastern Medical Oncology Center-Goldsboro
        • Contact:
        • Principal Investigator:
          • Samer S. Kasbari
      • Hendersonville, North Carolina, United States, 28791
        • Recruiting
        • Margaret R Pardee Memorial Hospital
        • Principal Investigator:
          • Praveen Vashist
        • Contact:
      • Jacksonville, North Carolina, United States, 28546
        • Recruiting
        • Southeastern Medical Oncology Center-Jacksonville
        • Principal Investigator:
          • Samer S. Kasbari
        • Contact:
      • Kenansville, North Carolina, United States, 28349
        • Recruiting
        • Vidant Oncology-Kenansville
        • Contact:
        • Principal Investigator:
          • Misbah U. Qadir
      • Kinston, North Carolina, United States, 28501
        • Recruiting
        • Vidant Oncology-Kinston
        • Contact:
        • Principal Investigator:
          • Misbah U. Qadir
      • Richlands, North Carolina, United States, 28574
        • Recruiting
        • Vidant Oncology-Richlands
        • Contact:
        • Principal Investigator:
          • Misbah U. Qadir
    • Ohio
      • Beavercreek, Ohio, United States, 45431
        • Suspended
        • Indu and Raj Soin Medical Center
      • Belpre, Ohio, United States, 45714
        • Recruiting
        • Strecker Cancer Center-Belpre
        • Contact:
        • Principal Investigator:
          • Timothy D. Moore
      • Boardman, Ohio, United States, 44512
        • Suspended
        • Saint Elizabeth Boardman Hospital
      • Canton, Ohio, United States, 44708
        • Recruiting
        • Cleveland Clinic Mercy Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 888-293-4673
        • Principal Investigator:
          • Mitchell Haut
      • Canton, Ohio, United States, 44708
        • Suspended
        • Mercy Hematology and Oncology Associates Inc
      • Centerville, Ohio, United States, 45459
        • Recruiting
        • Dayton Physicians LLC-Miami Valley South
        • Contact:
        • Principal Investigator:
          • Howard M. Gross
      • Centerville, Ohio, United States, 45459
        • Active, not recruiting
        • Miami Valley Hospital South
      • Chillicothe, Ohio, United States, 45601
        • Recruiting
        • Adena Regional Medical Center
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • University of Cincinnati Cancer Center-UC Medical Center
        • Contact:
        • Principal Investigator:
          • John C. Byrd
      • Cincinnati, Ohio, United States, 45220
        • Suspended
        • Good Samaritan Hospital - Cincinnati
      • Cincinnati, Ohio, United States, 45236
        • Suspended
        • Oncology Hematology Care Inc-Kenwood
      • Cincinnati, Ohio, United States, 45242
        • Suspended
        • Bethesda North Hospital
      • Cincinnati, Ohio, United States, 45247
        • Suspended
        • TriHealth Cancer Institute-Westside
      • Cincinnati, Ohio, United States, 45255
        • Suspended
        • TriHealth Cancer Institute-Anderson
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Foundation
        • Contact:
        • Principal Investigator:
          • Brian T. Hill
      • Cleveland, Ohio, United States, 44111
        • Recruiting
        • Cleveland Clinic Cancer Center/Fairview Hospital
        • Contact:
        • Principal Investigator:
          • Brian T. Hill
      • Columbus, Ohio, United States, 43219
        • Recruiting
        • The Mark H Zangmeister Center
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Seema A. Bhat
      • Columbus, Ohio, United States, 43213
        • Suspended
        • Mount Carmel East Hospital
      • Columbus, Ohio, United States, 43214
        • Suspended
        • Riverside Methodist Hospital
      • Columbus, Ohio, United States, 43222
        • Suspended
        • Mount Carmel Health Center West
      • Columbus, Ohio, United States, 43215
        • Suspended
        • Grant Medical Center
      • Columbus, Ohio, United States, 43228
        • Suspended
        • Doctors Hospital
      • Columbus, Ohio, United States, 43214
        • Suspended
        • Columbus Oncology and Hematology Associates Inc
      • Dayton, Ohio, United States, 45415
        • Recruiting
        • Dayton Physician LLC-Miami Valley Hospital North
        • Contact:
        • Principal Investigator:
          • Howard M. Gross
      • Dayton, Ohio, United States, 45415
        • Active, not recruiting
        • Miami Valley Hospital North
      • Dayton, Ohio, United States, 45409
        • Suspended
        • Miami Valley Hospital
      • Delaware, Ohio, United States, 43015
        • Suspended
        • Grady Memorial Hospital
      • Delaware, Ohio, United States, 43015
        • Suspended
        • Delaware Health Center-Grady Cancer Center
      • Dublin, Ohio, United States, 43016
        • Suspended
        • Dublin Methodist Hospital
      • Findlay, Ohio, United States, 45840
        • Recruiting
        • Armes Family Cancer Center
        • Contact:
        • Principal Investigator:
          • Howard M. Gross
      • Findlay, Ohio, United States, 45840
        • Suspended
        • Blanchard Valley Hospital
      • Findlay, Ohio, United States, 45840
        • Suspended
        • Orion Cancer Care
      • Franklin, Ohio, United States, 45005
        • Recruiting
        • Dayton Physicians LLC-Atrium
        • Contact:
        • Principal Investigator:
          • Howard M. Gross
      • Franklin, Ohio, United States, 45005-1066
        • Suspended
        • Atrium Medical Center-Middletown Regional Hospital
      • Gahanna, Ohio, United States, 43230
        • Suspended
        • Central Ohio Breast and Endocrine Surgery
      • Greenville, Ohio, United States, 45331
        • Suspended
        • Dayton Physicians LLC-Wayne
      • Greenville, Ohio, United States, 45331
        • Suspended
        • Wayne Hospital
      • Grove City, Ohio, United States, 43123
        • Suspended
        • Mount Carmel Grove City Hospital
      • Kettering, Ohio, United States, 45409
        • Recruiting
        • Greater Dayton Cancer Center
        • Contact:
        • Principal Investigator:
          • Howard M. Gross
      • Kettering, Ohio, United States, 45429
        • Recruiting
        • Kettering Medical Center
        • Contact:
        • Principal Investigator:
          • Howard M. Gross
      • Lancaster, Ohio, United States, 43130
        • Suspended
        • Fairfield Medical Center
      • Lima, Ohio, United States, 45801
        • Suspended
        • Saint Rita's Medical Center
      • Mansfield, Ohio, United States, 44903
        • Suspended
        • OhioHealth Mansfield Hospital
      • Marietta, Ohio, United States, 45750
        • Recruiting
        • Marietta Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Timothy D. Moore
      • Marion, Ohio, United States, 43302
        • Suspended
        • OhioHealth Marion General Hospital
      • Marysville, Ohio, United States, 43040
        • Recruiting
        • Memorial Hospital
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Mayfield Heights, Ohio, United States, 44124
        • Recruiting
        • Hillcrest Hospital Cancer Center
        • Contact:
        • Principal Investigator:
          • Brian T. Hill
      • Mount Vernon, Ohio, United States, 43050
        • Suspended
        • Knox Community Hospital
      • Newark, Ohio, United States, 43055
        • Recruiting
        • Licking Memorial Hospital
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Newark, Ohio, United States, 43055
        • Suspended
        • Newark Radiation Oncology
      • Perrysburg, Ohio, United States, 43551
        • Suspended
        • Mercy Health Perrysburg Cancer Center
      • Portsmouth, Ohio, United States, 45662
        • Recruiting
        • Southern Ohio Medical Center
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Springfield, Ohio, United States, 45504
        • Recruiting
        • Springfield Regional Cancer Center
        • Contact:
        • Principal Investigator:
          • Timothy D. Moore
      • Springfield, Ohio, United States, 45505
        • Suspended
        • Springfield Regional Medical Center
      • Sylvania, Ohio, United States, 43560
        • Recruiting
        • ProMedica Flower Hospital
        • Contact:
        • Principal Investigator:
          • Abhijit B. Saste
      • Toledo, Ohio, United States, 43623
        • Suspended
        • Mercy Health - Saint Anne Hospital
      • Toledo, Ohio, United States, 43608
        • Suspended
        • Saint Vincent Mercy Medical Center
      • Toledo, Ohio, United States, 43623
        • Recruiting
        • Toledo Clinic Cancer Centers-Toledo
        • Principal Investigator:
          • Rex B. Mowat
        • Contact:
          • Site Public Contact
          • Phone Number: 800-444-3561
      • Troy, Ohio, United States, 45373
        • Suspended
        • Upper Valley Medical Center
      • Troy, Ohio, United States, 45373
        • Suspended
        • Dayton Physicians LLC - Troy
      • Warren, Ohio, United States, 44484
        • Suspended
        • Saint Joseph Warren Hospital
      • West Chester, Ohio, United States, 45069
        • Recruiting
        • University of Cincinnati Cancer Center-West Chester
        • Contact:
        • Principal Investigator:
          • John C. Byrd
      • Westerville, Ohio, United States, 43081
        • Suspended
        • Saint Ann's Hospital
      • Wright-Patterson Air Force Base, Ohio, United States, 45433
        • Recruiting
        • Wright-Patterson Medical Center
        • Contact:
        • Principal Investigator:
          • Matthew Rendo
      • Youngstown, Ohio, United States, 44501
        • Suspended
        • Saint Elizabeth Youngstown Hospital
      • Zanesville, Ohio, United States, 43701
        • Recruiting
        • Genesis Healthcare System Cancer Care Center
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma Health Sciences Center
        • Contact:
        • Principal Investigator:
          • Mohamad Khawandanah
      • Oklahoma City, Oklahoma, United States, 73120
        • Suspended
        • Mercy Hospital Oklahoma City
    • Oregon
      • Baker City, Oregon, United States, 97814
        • Suspended
        • Saint Alphonsus Medical Center-Baker City
      • Bend, Oregon, United States, 97701
        • Suspended
        • Saint Charles Health System
      • Clackamas, Oregon, United States, 97015
        • Recruiting
        • Providence Cancer Institute Clackamas Clinic
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Clackamas, Oregon, United States, 97015
        • Recruiting
        • Clackamas Radiation Oncology Center
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Coos Bay, Oregon, United States, 97420
        • Suspended
        • Bay Area Hospital
      • Newberg, Oregon, United States, 97132
        • Recruiting
        • Providence Newberg Medical Center
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Ontario, Oregon, United States, 97914
        • Recruiting
        • Saint Alphonsus Medical Center-Ontario
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Oregon City, Oregon, United States, 97045
        • Recruiting
        • Providence Willamette Falls Medical Center
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence Portland Medical Center
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Providence Saint Vincent Medical Center
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Redmond, Oregon, United States, 97756
        • Suspended
        • Saint Charles Health System-Redmond
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Recruiting
        • Lehigh Valley Hospital-Cedar Crest
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Bethlehem, Pennsylvania, United States, 18017
        • Recruiting
        • Lehigh Valley Hospital - Muhlenberg
        • Contact:
        • Principal Investigator:
          • Elie G. Dib
      • Chadds Ford, Pennsylvania, United States, 19317
        • Suspended
        • Christiana Care Health System-Concord Health Center
      • Danville, Pennsylvania, United States, 17822
        • Recruiting
        • Geisinger Medical Center
        • Contact:
        • Principal Investigator:
          • Joseph J. Vadakara
      • East Stroudsburg, Pennsylvania, United States, 18301
        • Suspended
        • Pocono Medical Center
      • Hazleton, Pennsylvania, United States, 18201
        • Suspended
        • Lehigh Valley Hospital-Hazleton
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University Hospital
        • Contact:
        • Principal Investigator:
          • Gina M. Keiffer
      • Philadelphia, Pennsylvania, United States, 19114
        • Recruiting
        • Jefferson Torresdale Hospital
        • Contact:
        • Principal Investigator:
          • Gina M. Keiffer
      • Pittsburgh, Pennsylvania, United States, 15232
        • Active, not recruiting
        • University of Pittsburgh Cancer Institute (UPCI)
      • Wilkes-Barre, Pennsylvania, United States, 18711
        • Recruiting
        • Geisinger Wyoming Valley/Henry Cancer Center
        • Contact:
        • Principal Investigator:
          • Joseph J. Vadakara
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
        • Principal Investigator:
          • Brian T. Hess
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Suspended
        • Bristol Regional Medical Center
      • Kingsport, Tennessee, United States, 37660
        • Recruiting
        • Ballad Health Cancer Care - Kingsport
        • Principal Investigator:
          • Asheesh Shipstone
        • Contact:
      • Kingsport, Tennessee, United States, 37660
        • Suspended
        • Wellmont Holston Valley Hospital and Medical Center
      • Memphis, Tennessee, United States, 38120
        • Recruiting
        • Baptist Memorial Hospital and Cancer Center-Memphis
        • Contact:
        • Principal Investigator:
          • Muhammad Raza
      • Nashville, Tennessee, United States, 37232
        • Suspended
        • Vanderbilt University/Ingram Cancer Center
    • Texas
      • Bryan, Texas, United States, 77802
        • Suspended
        • Saint Joseph Regional Cancer Center
      • Dallas, Texas, United States, 75390
        • Recruiting
        • UT Southwestern/Simmons Cancer Center-Dallas
        • Contact:
        • Principal Investigator:
          • Farrukh T. Awan
      • Edinburg, Texas, United States, 78539
        • Recruiting
        • STCC at DHR Health Institute for Research and Development
        • Contact:
        • Principal Investigator:
          • Jose Cruz
      • Richardson, Texas, United States, 75080
        • Recruiting
        • UT Southwestern Clinical Center at Richardson/Plano
        • Contact:
        • Principal Investigator:
          • Farrukh T. Awan
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • Huntsman Cancer Institute/University of Utah
        • Principal Investigator:
          • Lindsey Fitzgerald
        • Contact:
    • Virginia
      • Bristol, Virginia, United States, 24201
        • Recruiting
        • Wellmont Medical Associates-Bristol
        • Contact:
        • Principal Investigator:
          • Asheesh Shipstone
      • Norton, Virginia, United States, 24273
        • Recruiting
        • Southwest VA Regional Cancer Center
        • Contact:
        • Principal Investigator:
          • Asheesh Shipstone
    • Washington
      • Aberdeen, Washington, United States, 98520
        • Suspended
        • Providence Regional Cancer System-Aberdeen
      • Bellevue, Washington, United States, 98004
        • Recruiting
        • FHCC Overlake
        • Contact:
          • Site Public Contact
          • Phone Number: 425-454-2148
        • Principal Investigator:
          • Jason Comer
      • Bellingham, Washington, United States, 98225
        • Suspended
        • PeaceHealth Saint Joseph Medical Center
      • Bremerton, Washington, United States, 98310
        • Recruiting
        • Harrison HealthPartners Hematology and Oncology-Bremerton
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • Bremerton, Washington, United States, 98310
        • Suspended
        • Harrison Medical Center
      • Burien, Washington, United States, 98166
        • Suspended
        • Highline Medical Center-Main Campus
      • Centralia, Washington, United States, 98531
        • Suspended
        • Providence Regional Cancer System-Centralia
      • Edmonds, Washington, United States, 98026
        • Recruiting
        • Swedish Cancer Institute-Edmonds
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Enumclaw, Washington, United States, 98022
        • Suspended
        • Saint Elizabeth Hospital
      • Everett, Washington, United States, 98201
        • Suspended
        • Providence Regional Cancer Partnership
      • Federal Way, Washington, United States, 98003
        • Suspended
        • Saint Francis Hospital
      • Issaquah, Washington, United States, 98029
        • Recruiting
        • Swedish Cancer Institute-Issaquah
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Kennewick, Washington, United States, 99336
        • Recruiting
        • Kadlec Clinic Hematology and Oncology
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Kirkland, Washington, United States, 98034
        • Recruiting
        • Seattle Cancer Care Alliance at EvergreenHealth
        • Principal Investigator:
          • Prakash Varadarajan
        • Contact:
          • Site Public Contact
          • Phone Number: 425-899-6000
      • Lacey, Washington, United States, 98503
        • Suspended
        • Providence Regional Cancer System-Lacey
      • Lakewood, Washington, United States, 98499
        • Suspended
        • Saint Clare Hospital
      • Longview, Washington, United States, 98632
        • Suspended
        • PeaceHealth Saint John Medical Center
      • Port Townsend, Washington, United States, 98368
        • Recruiting
        • Jefferson Healthcare
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
          • Site Public Contact
          • Phone Number: 360-344-3091
      • Poulsbo, Washington, United States, 98370
        • Active, not recruiting
        • Harrison HealthPartners Hematology and Oncology-Poulsbo
      • Seattle, Washington, United States, 98104
        • Suspended
        • Pacific Gynecology Specialists
      • Seattle, Washington, United States, 98107
        • Suspended
        • Swedish Medical Center-Ballard Campus
      • Seattle, Washington, United States, 98122-5711
        • Suspended
        • Swedish Medical Center-Cherry Hill
      • Seattle, Washington, United States, 98122
        • Recruiting
        • Swedish Medical Center-First Hill
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Seattle, Washington, United States, 98109
        • Recruiting
        • FHCC South Lake Union
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-8824
        • Principal Investigator:
          • Mazyar Shadman
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Fred Hutchinson Cancer Research Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-8824
        • Principal Investigator:
          • Mazyar Shadman
      • Seattle, Washington, United States, 98195
        • Recruiting
        • University of Washington Medical Center - Montlake
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-8824
        • Principal Investigator:
          • Mazyar Shadman
      • Seattle, Washington, United States, 98133
        • Recruiting
        • FHCC at Northwest Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 206-606-5800
        • Principal Investigator:
          • Paul S. Martin
      • Sedro-Woolley, Washington, United States, 98284
        • Suspended
        • PeaceHealth United General Medical Center
      • Shelton, Washington, United States, 98584
        • Suspended
        • Providence Regional Cancer System-Shelton
      • Tacoma, Washington, United States, 98405
        • Suspended
        • Franciscan Research Center-Northwest Medical Plaza
      • Tacoma, Washington, United States, 98405
        • Suspended
        • Northwest Medical Specialties PLLC
      • Vancouver, Washington, United States, 98664
        • Recruiting
        • PeaceHealth Southwest Medical Center
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Walla Walla, Washington, United States, 99362
        • Suspended
        • Providence Saint Mary Regional Cancer Center
      • Yakima, Washington, United States, 98902
        • Recruiting
        • North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
        • Principal Investigator:
          • John A. Ellerton
        • Contact:
      • Yelm, Washington, United States, 98597
        • Suspended
        • Providence Regional Cancer System-Yelm
    • Wisconsin
      • Appleton, Wisconsin, United States, 54911
        • Recruiting
        • ThedaCare Regional Cancer Center
        • Contact:
        • Principal Investigator:
          • Yazhini Vallatharasu
      • Eau Claire, Wisconsin, United States, 54701
      • Eau Claire, Wisconsin, United States, 54701
        • Recruiting
        • HSHS Sacred Heart Hospital
        • Contact:
        • Principal Investigator:
          • Matthew L. Ryan
      • Green Bay, Wisconsin, United States, 54301
        • Recruiting
        • Saint Vincent Hospital Cancer Center Green Bay
        • Contact:
        • Principal Investigator:
          • Matthew L. Ryan
      • Green Bay, Wisconsin, United States, 54303
        • Recruiting
        • Saint Vincent Hospital Cancer Center at Saint Mary's
        • Contact:
        • Principal Investigator:
          • Matthew L. Ryan
      • La Crosse, Wisconsin, United States, 54601
        • Recruiting
        • Gundersen Lutheran Medical Center
        • Contact:
        • Principal Investigator:
          • David E. Marinier
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University of Wisconsin Carbone Cancer Center
        • Principal Investigator:
          • Priyanka Pophali
        • Contact:
      • Marshfield, Wisconsin, United States, 54449
      • Minocqua, Wisconsin, United States, 54548
      • New Richmond, Wisconsin, United States, 54017
        • Suspended
        • Cancer Center of Western Wisconsin
      • Oconto Falls, Wisconsin, United States, 54154
        • Recruiting
        • Saint Vincent Hospital Cancer Center at Oconto Falls
        • Contact:
        • Principal Investigator:
          • Matthew L. Ryan
      • Rice Lake, Wisconsin, United States, 54868
      • Sheboygan, Wisconsin, United States, 53081
        • Recruiting
        • Saint Vincent Hospital Cancer Center at Sheboygan
        • Contact:
        • Principal Investigator:
          • Matthew L. Ryan
      • Stevens Point, Wisconsin, United States, 54482
      • Weston, Wisconsin, United States, 54476
    • Wyoming
      • Cheyenne, Wyoming, United States, 82001
        • Suspended
        • Cheyenne Regional Medical Center-West
      • Cody, Wyoming, United States, 82414
        • Suspended
        • Billings Clinic-Cody
      • Sheridan, Wyoming, United States, 82801
        • Suspended
        • Welch Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants must have a confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) (collectively referred to as CLL throughout) according to the 2018 International Workshop on CLL. Participants must have been diagnosed within 18 months prior to registration
  • Participants must have CLL-International Prognostic Index (CLL-IPI) score >= 4 and/or complex cytogenetics (defined as 3+ chromosomal abnormalities)
  • Cytogenetic AND/OR FISH analyses must be completed at a Clinical Laboratory Improvement Act (CLIA)-approved (or laboratories accredited under Accreditation Canada Diagnostics to conduct FISH analyses) laboratory within 18 months prior to registration. FISH panel should use probes to detect for abnormalities in chromosomes 13q, 12, 11q, and 17p
  • TP53 mutation status from an next generation sequencing (NGS) test performed at any CLIA-approved (or laboratories accredited under Accreditation Canada Diagnostics) lab (if completed) must be obtained within 18 months prior to registration. This sequencing test is distinct from FISH studies for del(17p)
  • Immunoglobulin heavy chain locus variable (IgVH) mutational status from an NGS test performed at any CLIA-approved lab (or laboratories accredited under Accreditation Canada Diagnostics) must be obtained prior to registration (at any time prior to registration)
  • Serum beta-2 microglobulin level must be obtained within 28 days prior to registration
  • Participants must not meet any of the IWCLL specified criteria for active CLL therapy
  • Treatment with high dose corticosteroids and/or intravenous immunoglobulin for autoimmune complications of CLL must be complete at least 4 weeks prior to enrollment
  • Steroids used for treatment of conditions other than CLL/SLL must be at a dose of at most 20 mg/day of prednisone or equivalent corticosteroid at the time of registration
  • Prior therapy with anti CD20 monoclonal antibodies is not allowed
  • Participants must not have received or be currently receiving any prior CLL-directed therapy, including non-protocol-related therapy, anti-cancer immunotherapy, experimental therapy (with exception of agents approved for emergency access use for the prevention or treatment of COVID-19), or radiotherapy
  • Participants must not be receiving or planning to receive any other investigational agents before completing protocol therapy
  • Participants must be >= 18 years of age
  • Participants must have Eastern Cooperative Oncology Group (ECOG) performance status =< 2
  • Platelet count >= 100,000/mm^3 within 28 days prior to registration
  • Absolute neutrophil count (ANC) >= 1,000/mm^3 within 28 days prior to registration
  • Creatinine clearance >= 30mL/min (by Cockcroft Gault) within 28 days prior to registration
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3.0 x upper limit of normal (ULN) within 28 days prior to registration
  • Total bilirubin =< 2.0 x ULN (or 5.0 x ULN if the participant has a history of Gilbert's disease), within 28 days prior to registration
  • Participants must be able to take oral medications
  • Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
  • Participants with history of malignancy are allowed providing the cancer has not required active treatment within 2 years prior to registration (hormonal therapy is permissible). The following exceptions are permissible: basal cell, squamous cell skin, or non-melanomatous skin cancer, in situ cervical cancer, superficial bladder cancer not treated with intravesical chemotherapy or Bacillus Calmette-Guerin (BCG) within 6 months, localized prostate cancer requiring no more than chronic hormonal therapy, or localized breast cancer requiring no more than chronic hormonal therapy
  • Participants must not have current, clinically significant gastrointestinal malabsorption, in the opinion of treating doctor
  • Participants must not have cirrhosis

  • Obinutuzumab has been associated with hepatitis reactivation. Participants must not have uncontrolled active infection with hepatitis B or C. Participants with latent hepatitis B infection must agree to take prophylaxis during and for 6 months following active protocol therapy with V-O.

    • Active infection with hepatitis B or C:

      • Active infection is defined as detectable hepatitis B deoxyribonucleic acid (DNA) or hepatitis C ribonucleic acid (RNA) by quantitative polymerase chain reaction (PCR).

    • Latent infection with hepatitis B:

      • Latent infection is defined as meeting all of the following criteria:

        • Hepatitis B surface antigen positive
        • Anti-hepatitis B total core antibody positive
        • Anti-hepatitis IgM core antibody undetectable
        • Hepatitis B PCR undetectable
      • Participants with latent hepatitis B infection must agree to take prophylaxis with anti-hepatitis agents during and for 6 months following active protocol therapy with V-O.
      • Participants who have received intravenous immunoglobulin (IVIG) therapy within 6 months who are hepatitis B core total antibody positive but PCR undetectable are not mandated to take prophylaxis
  • Participants must not have had major surgery within 30 days prior registration or minor surgery within 7 days prior to registration. Examples of major surgery include neurosurgical procedures, joint replacements, and surgeries that occur inside the thoracic or abdomino-pelvic cavities. Examples of minor surgery include dental surgery, insertion of a venous access device, skin biopsy, or aspiration of a joint. If a participant has had a bone marrow biopsy for diagnosis or evaluation of CLL, this will not exclude the patient from registration to the study. If there is a question about whether a surgery is major or minor, this should be discussed with the Study Chair
  • Participants must not have known bleeding disorders (e.g., von Willebrand's disease or hemophilia)
  • Participants must not have a history of stroke or intracranial hemorrhage within 6 months prior to enrollment
  • Participants must not require continued therapy with a strong inhibitor or inducer of CYP3A4/5, as venetoclax is extensively metabolized by CYP3A4/5
  • Participants must not have uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura
  • Participants must not have any currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification
  • Participants must not have a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to enrollment
  • Participants must not be pregnant or nursing, as there are no safety data available for these drug regimens during pregnancy. Women/men of reproductive potential must have agreed to use an effective contraceptive method. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
  • Participants must agree to have specimens submitted for translational medicine (MRD) and specimens must be submitted as outlined
  • Participants must be offered participation in banking for future research. With patient's consent, specimens must be submitted as outlined
  • Participants who are able to complete patient reported outcome (PRO) forms in English, Spanish, French, German, Russian or Mandarin must agree to participate in the quality of life assessments. (Those participants who are unable to read and write in English, Spanish, French, German, Russian or Mandarin may be registered to S1925 without contributing to the quality of life portion of the study.)
  • Participants must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
  • NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm I (delayed V-O)
Treatment begins once 2018 IWCLL indications are met. Patients receive obinutuzumab IV over 4 hours on days 1, 2, 8, and 15 of cycle 1 and on day 1 of cycles 2-6. Patients also receive venetoclax PO QD on days 22-28 of cycle 1 and on days 1-28 of cycles 2-12. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, collection of blood samples, and bone marrow aspiration throughout the trial.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Procedure: Biospecimen Collection
Undergo collection of blood samples
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Procedure: Computed Tomography
Undergo CT
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
  • Computerized axial tomography (procedure)
  • Computerized Tomography (CT) scan
Drug: Venetoclax
Given PO
Other Names:
  • Venclexta
  • ABT-0199
  • ABT-199
  • ABT199
  • GDC-0199
  • RG7601
  • Venclyxto
Procedure: Bone Marrow Aspiration
Undergo bone marrow aspiration
Biological: Obinutuzumab
Given IV
Other Names:
  • Gazyva
  • RO5072759
  • GA101
  • Anti-CD20 Monoclonal Antibody R7159
  • GA-101
  • huMAB(CD20)
  • R7159
  • RO 5072759
  • RO-5072759
Experimental: Arm II (early V-O)
Treatment begins as soon as eligibility criteria are met. Patients receive obinutuzumab IV over 4 hours on days 1, 2, 8, and 15 of cycle 1 and on day 1 of cycles 2-6. Patients also receive venetoclax PO QD on days 22-28 of cycle 1 and on days 1-28 of cycles 2-12. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, collection of blood samples, and bone marrow aspiration throughout the trial.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Procedure: Biospecimen Collection
Undergo collection of blood samples
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Procedure: Computed Tomography
Undergo CT
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
  • Computerized axial tomography (procedure)
  • Computerized Tomography (CT) scan
Drug: Venetoclax
Given PO
Other Names:
  • Venclexta
  • ABT-0199
  • ABT-199
  • ABT199
  • GDC-0199
  • RG7601
  • Venclyxto
Procedure: Bone Marrow Aspiration
Undergo bone marrow aspiration
Biological: Obinutuzumab
Given IV
Other Names:
  • Gazyva
  • RO5072759
  • GA101
  • Anti-CD20 Monoclonal Antibody R7159
  • GA-101
  • huMAB(CD20)
  • R7159
  • RO 5072759
  • RO-5072759

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: From the day of registration on study until death from any cause with observations censored on the day of last contact for patients not known to have died, assessed up to 10 years
The final analysis will use stratified Cox proportional hazards regression stratified by Chronic Lymphocytic Leukemia [CLL] International Prognostic Indicator [CLL-IPI] Risk score status (high risk versus very high risk) with a two-sided alpha of 0.042. The final analysis will occur after 58 OS events have been observed, or at 4 years after accrual completes, whichever occurs first. Under the alternative hypothesis, the final analysis is expected to occur at approximately 7.9 years after study activation (about 3.8 years after accrual completes).
From the day of registration on study until death from any cause with observations censored on the day of last contact for patients not known to have died, assessed up to 10 years
Functional Assessment of Cancer Therapy (FACT)-Leukemia total score
Time Frame: At 2 years
A single comparison in the FACT-Leukemia total scores between patients randomized to early V-O versus delayed V-O will be conducted at the alpha=.05 level. The analysis of the 2-year FACT-Leukemia Total score will be conducted using multiple linear regression analysis, adjusting for stratification factor and the baseline FACT-Leukemia Total score as covariates. Will also conduct longitudinal modeling of the outcome measures over time.
At 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events
Time Frame: Up to 10 years
Will utilize the CTCAE (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events) version 5.0 for toxicity and adverse event reporting.
Up to 10 years
Overall Response rate
Time Frame: Up to 10 years
Will be compared using Fisher's exact test.
Up to 10 years
Progression free survival
Time Frame: From the day of registration on study until the first of: relapse from complete response, progression, or death from any cause, assessed up to 10 years
Will be estimated using the Kaplan-Meier method and will be compared using log-rank tests and Cox regression models.
From the day of registration on study until the first of: relapse from complete response, progression, or death from any cause, assessed up to 10 years
Event free survival
Time Frame: From the day of registration on study until the first of: relapse from complete response, death from any cause, start of new (non-protocol) therapy, or completion of protocol therapy without documentation of complete response, assessed up to 10 years
Will be estimated using the Kaplan-Meier method and will be compared using log-rank tests and Cox regression models.
From the day of registration on study until the first of: relapse from complete response, death from any cause, start of new (non-protocol) therapy, or completion of protocol therapy without documentation of complete response, assessed up to 10 years
Relapse free survival
Time Frame: From the date the patient first achieves complete response until relapse from complete response or death from any cause, assessed up to 10 years
Will be estimated using the Kaplan-Meier method and will be compared using log-rank tests and Cox regression models.
From the date the patient first achieves complete response until relapse from complete response or death from any cause, assessed up to 10 years
Time to second treatment
Time Frame: Up to 10 years
Will be defined as the next chronic lymphocytic leukemia (CLL) treatment the patient receives after removal from protocol therapy. Will be estimated using the Kaplan-Meier method and will be compared using log-rank tests and Cox regression models.
Up to 10 years
Patient compliance
Time Frame: Up to 10 years
Will be reported descriptively by arm.
Up to 10 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
FACT-Leukemia total score
Time Frame: At randomization and at months 3, 6, 9, 12, 15, 18, 24, 30, and 36
Will include linear regression analyses by arm.
At randomization and at months 3, 6, 9, 12, 15, 18, 24, 30, and 36
The individual components of the FACT-Leukemia
Time Frame: At randomization and at months 3, 6, 9, 12, 15, 18, 24, 30, and 36
Will include physical, social, emotional, and functional well-being. Will include linear regression analyses by arm.
At randomization and at months 3, 6, 9, 12, 15, 18, 24, 30, and 36
Patient-reported health-related quality of life (HRQoL)
Time Frame: Up to 36 months
Will use simple descriptive statistics (means, medians, standard deviations, ranges) to describe patient-reported health related quality of life using the FACT-Leukemia and its individual domains between randomized arms. To assess potential trends, P-values using t-tests will be provided.
Up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Deborah M Stephens, SWOG Cancer Research Network

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2021

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

October 1, 2028

Study Registration Dates

First Submitted

February 13, 2020

First Submitted That Met QC Criteria

February 13, 2020

First Posted (Actual)

February 17, 2020

Study Record Updates

Last Update Posted (Estimated)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2020-00752 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • U10CA180888 (U.S. NIH Grant/Contract)
  • S1925 (Other Identifier: CTEP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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