Rituximab With or Without Stem Cell Transplant in Treating Patients With Minimal Residual Disease-Negative Mantle Cell Lymphoma in First Complete Remission

June 21, 2023 updated by: ECOG-ACRIN Cancer Research Group

A Randomized Phase III Trial of Consolidation With Autologous Hematopoietic Cell Transplantation Followed by Maintenance Rituximab vs. Maintenance Rituximab Alone for Patients With Mantle Cell Lymphoma in Minimal Residual Disease-Negative First Complete Remission

This randomized phase III trial studies rituximab after stem cell transplant and to see how well it works compared with rituximab alone in treating patients with in minimal residual disease-negative mantle cell lymphoma in first complete remission. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Giving chemotherapy before a stem cell transplant helps kill any cancer cells that are in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Giving rituximab with or without stem cell transplant may work better in treating patients with mantle cell lymphoma.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To compare overall survival in mantle cell lymphoma (MCL) patients in minimal residual disease (MRD)-negative first remission who undergo autologous hematopoietic stem cell transplantation (auto-HCT) followed by maintenance rituximab versus (vs.) maintenance rituximab alone (without auto-HCT).

SECONDARY OBJECTIVES:

I. To compare progression-free survival in MCL patients in MRD-negative first remission who undergo auto-HCT followed by maintenance rituximab vs. maintenance rituximab alone.

II. To define the overall survival and progression-free survival at 2 and 5 years of chemosensitive but MRD-positive (or MRD-indeterminate) patients who undergo auto-HCT followed by 2 years of maintenance rituximab.

III. To describe the rate of complications (serious infection, hospitalization, need for intravenous immune globulin) in MCL patients undergoing maintenance rituximab following auto-HCT.

IV. To determine the prognostic impact of MRD status at day 100, in MCL patients who were MRD-positive prior to auto-HCT.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive standard of care preparative chemotherapy and undergo auto-HCT. Beginning 60-120 days after transplant, patients receive rituximab intravenously (IV) once every 8 weeks for up to 18 courses in the absence of disease progression or unacceptable toxicity.

GROUP II: Patients receive standard of care induction chemotherapy. Beginning 40-120 days after completion of chemotherapy, patients receive rituximab as in Group I.

After completion of study treatment, patients are followed up every 3 and 6 months for 10 years.

Study Type

Interventional

Enrollment (Estimated)

689

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

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • University of Alabama at Birmingham Cancer Center
        • Principal Investigator:
          • Amitkumar N. Mehta
        • Contact:
    • Alaska
      • Anchorage, Alaska, United States, 99508
      • Anchorage, Alaska, United States, 99508
      • Anchorage, Alaska, United States, 99508
      • Anchorage, Alaska, United States, 98508
      • Anchorage, Alaska, United States, 99504
      • Anchorage, Alaska, United States, 99508
      • Anchorage, Alaska, United States, 99508
      • Anchorage, Alaska, United States, 99508
      • Fairbanks, Alaska, United States, 99701
        • Recruiting
        • Fairbanks Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Nicholas DiBella
    • Arizona
      • Kingman, Arizona, United States, 86401
        • Recruiting
        • Kingman Regional Medical Center
        • Principal Investigator:
          • John A. Ellerton
        • Contact:
      • Tucson, Arizona, United States, 85719
        • Recruiting
        • Banner University Medical Center - Tucson
        • Principal Investigator:
          • Daniel O. Persky
        • Contact:
      • Tucson, Arizona, United States, 85719
        • Recruiting
        • University of Arizona Cancer Center-North Campus
        • Principal Investigator:
          • Daniel O. Persky
        • Contact:
          • Site Public Contact
          • Phone Number: 800-327-2873
      • Tucson, Arizona, United States, 85704
        • Recruiting
        • University of Arizona Cancer Center-Orange Grove Campus
        • Principal Investigator:
          • Daniel O. Persky
        • Contact:
          • Site Public Contact
          • Phone Number: 520-694-8900
    • California
      • Arroyo Grande, California, United States, 93420
        • Recruiting
        • PCR Oncology
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Burbank, California, United States, 91505
        • Recruiting
        • Providence Saint Joseph Medical Center/Disney Family Cancer Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope Comprehensive Cancer Center
        • Principal Investigator:
          • Leslie L. Popplewell
        • Contact:
      • La Jolla, California, United States, 92093
        • Recruiting
        • UC San Diego Moores Cancer Center
        • Principal Investigator:
          • Carolyn M. Mulroney
        • Contact:
      • San Francisco, California, United States, 94143
        • Recruiting
        • UCSF Medical Center-Parnassus
        • Principal Investigator:
          • Lawrence D. Kaplan
        • Contact:
          • Site Public Contact
          • Phone Number: 877-827-3222
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Recruiting
        • Rocky Mountain Cancer Centers-Aurora
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
      • Aurora, Colorado, United States, 80012
        • Recruiting
        • The Medical Center of Aurora
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
      • Boulder, Colorado, United States, 80301
        • Recruiting
        • Boulder Community Hospital
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
      • Boulder, Colorado, United States, 80304
        • Recruiting
        • Rocky Mountain Cancer Centers-Boulder
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Colorado Blood Cancer Institute
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
      • Denver, Colorado, United States, 80206
        • Recruiting
        • National Jewish Health-Main Campus
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
      • 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, 80204
        • Suspended
        • Denver Health Medical Center
      • Denver, Colorado, United States, 80209
        • Recruiting
        • The Women's Imaging Center
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Presbyterian - Saint Lukes Medical Center - Health One
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
      • Denver, Colorado, United States, 80220
        • Recruiting
        • Rose Medical Center
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
      • Denver, Colorado, United States, 80218
        • Recruiting
        • SCL Health Saint Joseph Hospital
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
      • Denver, Colorado, United States, 80204
        • Recruiting
        • Cancer Center of Colorado at Sloan's Lake
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
          • Site Public Contact
          • Phone Number: 303-777-2663
      • Englewood, Colorado, United States, 80113
        • Recruiting
        • Mountain Blue Cancer Care Center - Swedish
        • Contact:
        • Principal Investigator:
          • Nicholas DiBella
      • Englewood, Colorado, United States, 80113
        • Recruiting
        • Swedish Medical Center
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
      • Golden, Colorado, United States, 80401
        • Recruiting
        • National Jewish Health-Western Hematology Oncology
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
      • Grand Junction, Colorado, United States, 81505
        • Active, not recruiting
        • Grand Valley Oncology
      • Grand Junction, Colorado, United States, 81501
        • Recruiting
        • Saint Mary's Hospital and Regional Medical Center
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
      • Greeley, Colorado, United States, 80631
        • Recruiting
        • North Colorado Medical Center
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
      • Greenwood Village, Colorado, United States, 80111
        • Suspended
        • Rocky Mountain Cancer Centers-Greenwood Village
      • Lafayette, Colorado, United States, 80026
        • Recruiting
        • Good Samaritan Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 303-673-1622
        • Principal Investigator:
          • Nicholas DiBella
      • Littleton, Colorado, United States, 80120
        • Recruiting
        • Rocky Mountain Cancer Centers-Littleton
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
      • Lone Tree, Colorado, United States, 80124
        • Recruiting
        • Rocky Mountain Cancer Centers-Sky Ridge
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
      • Lone Tree, Colorado, United States, 80124
        • Recruiting
        • Sky Ridge Medical Center
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
      • Loveland, Colorado, United States, 80539
        • Recruiting
        • McKee Medical Center
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
      • Thornton, Colorado, United States, 80260
        • Recruiting
        • National Jewish Health-Northern Hematology Oncology
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
      • Wheat Ridge, Colorado, United States, 80033
        • Recruiting
        • SCL Health Lutheran Medical Center
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
    • Connecticut
      • Hartford, Connecticut, United States, 06105
        • Recruiting
        • Smilow Cancer Hospital Care Center at Saint Francis
        • Principal Investigator:
          • Iris Isufi
        • Contact:
      • New Haven, Connecticut, United States, 06520
        • Recruiting
        • Yale University
        • Principal Investigator:
          • Iris Isufi
        • Contact:
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Smilow Cancer Center/Yale-New Haven Hospital
        • Principal Investigator:
          • Iris Isufi
        • Contact:
    • Florida
      • Gainesville, Florida, United States, 32610
        • Recruiting
        • University of Florida Health Science Center - Gainesville
        • Principal Investigator:
          • John R. Wingard
        • Contact:
      • Jacksonville, Florida, United States, 32224-9980
        • Recruiting
        • Mayo Clinic in Florida
        • Principal Investigator:
          • David J. Inwards
        • Contact:
          • Site Public Contact
          • Phone Number: 855-776-0015
      • Jacksonville, Florida, United States, 32207
        • Recruiting
        • Baptist MD Anderson Cancer Center
        • Principal Investigator:
          • William A. Hammond
        • Contact:
          • Site Public Contact
          • Phone Number: 904-202-7468
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami Miller School of Medicine-Sylvester Cancer Center
        • Principal Investigator:
          • Amer M. Beitinjaneh
        • Contact:
          • Site Public Contact
          • Phone Number: 305-243-2647
      • Tampa, Florida, United States, 33607
        • Recruiting
        • Moffitt Cancer Center-International Plaza
        • Principal Investigator:
          • Hien D. Liu
        • Contact:
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center - McKinley Campus
        • Principal Investigator:
          • Hien D. Liu
        • Contact:
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center
        • Principal Investigator:
          • Hien D. Liu
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University Hospital/Winship Cancer Institute
        • Contact:
          • Site Public Contact
          • Phone Number: 404-778-1868
        • Principal Investigator:
          • Kristie A. Blum
      • Atlanta, Georgia, United States, 30342
        • Recruiting
        • Emory Saint Joseph's Hospital
        • Principal Investigator:
          • Kristie A. Blum
        • Contact:
          • Site Public Contact
          • Phone Number: 404-851-7115
      • Augusta, Georgia, United States, 30912
        • Recruiting
        • Augusta University Medical Center
        • Principal Investigator:
          • Sharad A. Ghamande
        • Contact:
    • Idaho
      • Boise, Idaho, United States, 83706
        • Recruiting
        • Saint Alphonsus Cancer Care Center-Boise
        • Contact:
        • Principal Investigator:
          • John M. Schallenkamp
      • Boise, Idaho, United States, 83712
        • Recruiting
        • Saint Luke's Mountain States Tumor Institute
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • 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 Medical Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Emmett, Idaho, United States, 83617
        • Recruiting
        • Walter Knox Memorial Hospital
        • Contact:
        • Principal Investigator:
          • John M. Schallenkamp
      • Fruitland, Idaho, United States, 83619
        • Recruiting
        • Saint Luke's Mountain States Tumor Institute - Fruitland
        • Contact:
        • Principal Investigator:
          • Alison K. Conlin
      • Meridian, Idaho, United States, 83642
        • Recruiting
        • Idaho Urologic Institute-Meridian
        • Contact:
        • Principal Investigator:
          • John M. Schallenkamp
      • Meridian, Idaho, United States, 83642
        • Recruiting
        • Saint Luke's Mountain States Tumor Institute - Meridian
        • Contact:
        • Principal Investigator:
          • Alison K. Conlin
      • Nampa, Idaho, United States, 83686
        • Recruiting
        • Saint Alphonsus Medical Center-Nampa
        • Contact:
        • Principal Investigator:
          • John M. Schallenkamp
      • Nampa, Idaho, United States, 83686
        • Recruiting
        • Saint Luke's Mountain States Tumor Institute - Nampa
        • Contact:
        • Principal Investigator:
          • Alison K. Conlin
      • Post Falls, Idaho, United States, 83854
        • Recruiting
        • Kootenai Cancer Center
        • 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
        • Recruiting
        • Saint Luke's Mountain States Tumor Institute-Twin Falls
        • Contact:
        • Principal Investigator:
          • Alison K. Conlin
    • Illinois
      • Burr Ridge, Illinois, United States, 60527
        • Recruiting
        • Loyola Center for Health at Burr Ridge
        • Principal Investigator:
          • Patrick J. Stiff
        • Contact:
          • Site Public Contact
          • Phone Number: 708-216-9000
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush University Medical Center
        • Principal Investigator:
          • Sunita Nathan
        • Contact:
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Peter Riedell
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Principal Investigator:
          • Jane N. Winter
        • Contact:
      • DeKalb, Illinois, United States, 60115
        • Recruiting
        • Northwestern Medicine Cancer Center Kishwaukee
        • Contact:
        • Principal Investigator:
          • Robert M. Eisner
      • Geneva, Illinois, United States, 60134
        • Recruiting
        • Northwestern Medicine Cancer Center Delnor
        • Contact:
        • Principal Investigator:
          • Robert M. Eisner
      • Lake Forest, Illinois, United States, 60045
        • Recruiting
        • Northwestern Medicine Lake Forest Hospital
        • Principal Investigator:
          • Jane N. Winter
        • Contact:
      • Maywood, Illinois, United States, 60153
        • Recruiting
        • Loyola University Medical Center
        • Principal Investigator:
          • Patrick J. Stiff
        • Contact:
          • Site Public Contact
          • Phone Number: 708-226-4357
      • Melrose Park, Illinois, United States, 60160
        • Recruiting
        • Marjorie Weinberg Cancer Center at Loyola-Gottlieb
        • Principal Investigator:
          • Patrick J. Stiff
        • Contact:
          • Site Public Contact
          • Phone Number: 708-450-4554
      • New Lenox, Illinois, United States, 60451
        • Recruiting
        • UC Comprehensive Cancer Center at Silver Cross
        • Contact:
        • Principal Investigator:
          • Peter Riedell
      • Orland Park, Illinois, United States, 60462
        • Recruiting
        • University of Chicago Medicine-Orland Park
        • Contact:
        • Principal Investigator:
          • Peter Riedell
      • Orland Park, Illinois, United States, 60462
        • Recruiting
        • Loyola Center for Cancer Care and Research
        • Principal Investigator:
          • Patrick J. Stiff
        • Contact:
          • Site Public Contact
          • Phone Number: 708-216-9000
      • Warrenville, Illinois, United States, 60555
        • Recruiting
        • Northwestern Medicine Cancer Center Warrenville
        • Contact:
        • Principal Investigator:
          • Robert M. Eisner
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University/Melvin and Bren Simon Cancer Center
        • Principal Investigator:
          • Michael J. Robertson
        • Contact:
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Sidney and Lois Eskenazi Hospital
        • Principal Investigator:
          • Michael J. Robertson
        • Contact:
    • Kansas
      • Chanute, Kansas, United States, 66720
        • Recruiting
        • Cancer Center of Kansas - Chanute
        • Contact:
        • Principal Investigator:
          • Shaker R. Dakhil
      • Dodge City, Kansas, United States, 67801
        • Recruiting
        • Cancer Center of Kansas - Dodge City
        • Contact:
        • Principal Investigator:
          • Shaker R. Dakhil
      • El Dorado, Kansas, United States, 67042
        • Recruiting
        • Cancer Center of Kansas - El Dorado
        • Contact:
        • Principal Investigator:
          • Shaker R. Dakhil
      • Fort Scott, Kansas, United States, 66701
        • Suspended
        • Cancer Center of Kansas - Fort Scott
      • Independence, Kansas, United States, 67301
        • Recruiting
        • Cancer Center of Kansas-Independence
        • Contact:
        • Principal Investigator:
          • Shaker R. Dakhil
      • Kingman, Kansas, United States, 67068
        • Recruiting
        • Cancer Center of Kansas-Kingman
        • Contact:
        • Principal Investigator:
          • Shaker R. Dakhil
      • Lawrence, Kansas, United States, 66044
        • Recruiting
        • Lawrence Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Shaker R. Dakhil
      • Liberal, Kansas, United States, 67905
        • Recruiting
        • Cancer Center of Kansas-Liberal
        • Contact:
        • Principal Investigator:
          • Shaker R. Dakhil
      • Manhattan, Kansas, United States, 66502
        • Recruiting
        • Cancer Center of Kansas-Manhattan
        • Principal Investigator:
          • Shaker R. Dakhil
        • Contact:
      • McPherson, Kansas, United States, 67460
        • Recruiting
        • Cancer Center of Kansas - McPherson
        • Contact:
        • Principal Investigator:
          • Shaker R. Dakhil
      • Newton, Kansas, United States, 67114
        • Recruiting
        • Cancer Center of Kansas - Newton
        • Contact:
        • Principal Investigator:
          • Shaker R. Dakhil
      • Parsons, Kansas, United States, 67357
        • Recruiting
        • Cancer Center of Kansas - Parsons
        • Contact:
        • Principal Investigator:
          • Shaker R. Dakhil
      • Pratt, Kansas, United States, 67124
        • Recruiting
        • Cancer Center of Kansas - Pratt
        • Contact:
        • Principal Investigator:
          • Shaker R. Dakhil
      • Salina, Kansas, United States, 67401
        • Recruiting
        • Cancer Center of Kansas - Salina
        • Contact:
        • Principal Investigator:
          • Shaker R. Dakhil
      • Wellington, Kansas, United States, 67152
        • Recruiting
        • Cancer Center of Kansas - Wellington
        • Contact:
        • Principal Investigator:
          • Shaker R. Dakhil
      • Westwood, Kansas, United States, 66205
        • Recruiting
        • University of Kansas Hospital-Westwood Cancer Center
        • Principal Investigator:
          • Siddhartha Ganguly
        • Contact:
      • Wichita, Kansas, United States, 67208
        • Suspended
        • Associates In Womens Health
      • Wichita, Kansas, United States, 67208
        • Recruiting
        • Cancer Center of Kansas-Wichita Medical Arts Tower
        • Contact:
        • Principal Investigator:
          • Shaker R. Dakhil
      • Wichita, Kansas, United States, 67214
        • Recruiting
        • Ascension Via Christi Hospitals Wichita
        • Principal Investigator:
          • Shaker R. Dakhil
        • Contact:
      • Wichita, Kansas, United States, 67214
        • Recruiting
        • Cancer Center of Kansas - Wichita
        • Contact:
        • Principal Investigator:
          • Shaker R. Dakhil
      • Winfield, Kansas, United States, 67156
        • Recruiting
        • Cancer Center of Kansas - Winfield
        • Contact:
        • Principal Investigator:
          • Shaker R. Dakhil
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Recruiting
        • University of Kentucky/Markey Cancer Center
        • Principal Investigator:
          • Maxwell Krem
        • Contact:
          • Site Public Contact
          • Phone Number: 859-257-3379
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • The James Graham Brown Cancer Center at University of Louisville
        • Principal Investigator:
          • Robert V. Emmons
        • Contact:
          • Site Public Contact
          • Phone Number: 502-562-3429
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins University/Sidney Kimmel Cancer Center
        • Principal Investigator:
          • Nina D. Wagner-Johnston
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital Cancer Center
        • Principal Investigator:
          • Ann S. LaCasce
        • Contact:
          • Site Public Contact
          • Phone Number: 877-726-5130
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana-Farber Cancer Institute
        • Principal Investigator:
          • Ann S. LaCasce
        • Contact:
          • Site Public Contact
          • Phone Number: 877-442-3324
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess Medical Center
        • Principal Investigator:
          • Ann S. LaCasce
        • Contact:
          • Site Public Contact
          • Phone Number: 617-667-9925
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan Comprehensive Cancer Center
        • Principal Investigator:
          • Attaphol Pawarode
        • Contact:
          • Site Public Contact
          • Phone Number: 800-865-1125
      • Port Huron, Michigan, United States, 48060
        • Suspended
        • Huron Medical Center PC
      • Port Huron, Michigan, United States, 48060
        • Suspended
        • Lake Huron Medical Center
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Principal Investigator:
          • David J. Inwards
        • Contact:
          • Site Public Contact
          • Phone Number: 855-776-0015
    • Missouri
      • Creve Coeur, Missouri, United States, 63141
        • Recruiting
        • Siteman Cancer Center at West County Hospital
        • Principal Investigator:
          • Amanda F. Cashen
        • Contact:
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Principal Investigator:
          • Amanda F. Cashen
        • Contact:
      • Saint Louis, Missouri, United States, 63129
        • Recruiting
        • Siteman Cancer Center-South County
        • Principal Investigator:
          • Amanda F. Cashen
        • Contact:
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Saint Louis University Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 314-977-4440
        • Principal Investigator:
          • Mark J. Fesler
      • Saint Peters, Missouri, United States, 63376
        • Recruiting
        • Siteman Cancer Center at Saint Peters Hospital
        • Principal Investigator:
          • Amanda F. Cashen
        • Contact:
    • 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, 59102
        • Recruiting
        • Saint Vincent Frontier Cancer Center
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
          • Site Public Contact
          • Phone Number: 800-648-6274
      • Billings, Montana, United States, 59101
        • Recruiting
        • Saint Vincent Healthcare
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
      • Bozeman, Montana, United States, 59715
        • Recruiting
        • Bozeman Deaconess Hospital
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Butte, Montana, United States, 59701
        • Recruiting
        • Saint James Community Hospital and Cancer Treatment Center
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
          • Site Public Contact
          • Phone Number: 406-723-2621
      • Great Falls, Montana, United States, 59405
        • Recruiting
        • Benefis Healthcare- Sletten Cancer Institute
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Great Falls, Montana, United States, 59405
        • Recruiting
        • Great Falls Clinic
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Helena, Montana, United States, 59601
        • Suspended
        • Saint Peter's Community Hospital
      • Kalispell, Montana, United States, 59901
        • Recruiting
        • Kalispell Regional Medical Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Missoula, Montana, United States, 59804
        • Recruiting
        • Community Medical Hospital
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Missoula, Montana, United States, 59802
        • Recruiting
        • Saint Patrick Hospital - Community Hospital
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
    • Nebraska
      • Bellevue, Nebraska, United States, 68123
        • Recruiting
        • Nebraska Medicine-Bellevue
        • Principal Investigator:
          • Matthew A. Lunning
        • Contact:
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • University of Nebraska Medical Center
        • Principal Investigator:
          • Matthew A. Lunning
        • Contact:
      • Omaha, Nebraska, United States, 68118
        • Recruiting
        • Nebraska Medicine-Village Pointe
        • Principal Investigator:
          • Matthew A. Lunning
        • Contact:
          • Site Public Contact
          • Phone Number: 402-559-5600
    • Nevada
      • Carson City, Nevada, United States, 89703
        • Recruiting
        • Carson Tahoe Regional Medical Center
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Henderson, Nevada, United States, 89052
        • Recruiting
        • Cancer and Blood Specialists-Henderson
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Henderson, Nevada, United States, 89052
        • Recruiting
        • Comprehensive Cancer Centers of Nevada - Henderson
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Henderson, Nevada, United States, 89052
        • Recruiting
        • Comprehensive Cancer Centers of Nevada-Horizon Ridge
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Henderson, Nevada, United States, 89052
        • Recruiting
        • Las Vegas Cancer Center-Henderson
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Henderson, Nevada, United States, 89052
        • Recruiting
        • OptumCare Cancer Care at Seven Hills
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Henderson, Nevada, United States, 89074
        • Recruiting
        • Comprehensive Cancer Centers of Nevada-Southeast Henderson
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Henderson, Nevada, United States, 89074
        • Recruiting
        • Las Vegas Urology - Green Valley
        • Principal Investigator:
          • John A. Ellerton
        • Contact:
      • Henderson, Nevada, United States, 89074
        • Recruiting
        • Las Vegas Urology - Pebble
        • Principal Investigator:
          • John A. Ellerton
        • Contact:
      • Henderson, Nevada, United States, 89074
        • Recruiting
        • Urology Specialists of Nevada - Green Valley
        • Principal Investigator:
          • John A. Ellerton
        • Contact:
      • Henderson, Nevada, United States, 89074
        • Recruiting
        • 21st Century Oncology-Henderson
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89074
        • Recruiting
        • Las Vegas Urology - Pecos
        • Principal Investigator:
          • John A. Ellerton
        • Contact:
      • Las Vegas, Nevada, United States, 89102
        • Recruiting
        • University Medical Center of Southern Nevada
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89103
        • Recruiting
        • Hope Cancer Care of Nevada
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89106
        • Recruiting
        • Radiation Oncology Centers of Nevada Central
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89106
        • Recruiting
        • Urology Specialists of Nevada - Central
        • Principal Investigator:
          • John A. Ellerton
        • Contact:
      • Las Vegas, Nevada, United States, 89109
        • Recruiting
        • Sunrise Hospital and Medical Center
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89113
        • Recruiting
        • Las Vegas Prostate Cancer Center
        • Principal Investigator:
          • John A. Ellerton
        • Contact:
      • Las Vegas, Nevada, United States, 89113
        • Recruiting
        • Las Vegas Urology - Sunset
        • Principal Investigator:
          • John A. Ellerton
        • Contact:
      • Las Vegas, Nevada, United States, 89119
        • Recruiting
        • Radiation Oncology Centers of Nevada Southeast
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89128
        • Recruiting
        • Ann M Wierman MD LTD
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89128
        • Recruiting
        • Comprehensive Cancer Centers of Nevada - Northwest
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89128
        • Recruiting
        • Las Vegas Urology - Cathedral Rock
        • Principal Investigator:
          • John A. Ellerton
        • Contact:
      • Las Vegas, Nevada, United States, 89128
        • Recruiting
        • Las Vegas Urology - Smoke Ranch
        • Principal Investigator:
          • John A. Ellerton
        • Contact:
      • Las Vegas, Nevada, United States, 89128
        • Recruiting
        • OptumCare Cancer Care at MountainView
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89128
        • Recruiting
        • Urology Specialists of Nevada - Northwest
        • Principal Investigator:
          • John A. Ellerton
        • Contact:
      • Las Vegas, Nevada, United States, 89135
        • Recruiting
        • Alliance for Childhood Diseases/Cure 4 the Kids Foundation
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89144
        • Recruiting
        • Comprehensive Cancer Centers of Nevada - Town Center
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89144
        • Recruiting
        • Comprehensive Cancer Centers of Nevada-Summerlin
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89144
        • Recruiting
        • Summerlin Hospital Medical Center
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89148-2405
        • Recruiting
        • Las Vegas Cancer Center-Medical Center
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89148
        • Recruiting
        • Comprehensive Cancer Centers of Nevada
        • 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
      • Las Vegas, Nevada, United States, 89169
        • Recruiting
        • Comprehensive Cancer Centers of Nevada - Central Valley
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89169
        • Recruiting
        • University Cancer Center
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89109
        • Recruiting
        • 21st Century Oncology
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89102
        • Recruiting
        • Desert West Surgery
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89128
        • Recruiting
        • 21st Century Oncology-Vegas Tenaya
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89148
        • Recruiting
        • 21st Century Oncology-Fort Apache
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89148
        • Recruiting
        • Urology Specialists of Nevada - Southwest
        • Principal Investigator:
          • John A. Ellerton
        • Contact:
      • Las Vegas, Nevada, United States, 89102
        • Recruiting
        • OptumCare Cancer Care at Oakey
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89106
        • Recruiting
        • Cancer and Blood Specialists-Shadow
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89109
        • Recruiting
        • HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89113
        • Recruiting
        • HealthCare Partners Medical Group Oncology/Hematology-San Martin
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89128
        • Recruiting
        • Cancer and Blood Specialists-Tenaya
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89128
        • Recruiting
        • HealthCare Partners Medical Group Oncology/Hematology-Tenaya
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89149
        • Recruiting
        • HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Pahrump, Nevada, United States, 89048
        • Recruiting
        • Hope Cancer Care of Nevada-Pahrump
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Reno, Nevada, United States, 89502
        • Recruiting
        • Renown Regional Medical Center
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Reno, Nevada, United States, 89503
        • Recruiting
        • Saint Mary's Regional Medical Center
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Reno, Nevada, United States, 89509
        • Recruiting
        • Radiation Oncology Associates
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Recruiting
        • Dartmouth Hitchcock Medical Center
        • Contact:
        • Principal Investigator:
          • Frederick Lansigan
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • Recruiting
        • Rutgers Cancer Institute of New Jersey
        • Contact:
          • Site Public Contact
          • Phone Number: 732-235-8675
        • Principal Investigator:
          • Kevin A. David
    • New York
      • Buffalo, New York, United States, 14263
        • Not yet recruiting
        • Roswell Park Cancer Institute
        • Principal Investigator:
          • Pallawi Torka
        • Contact:
      • Glens Falls, New York, United States, 12801
        • Recruiting
        • Glens Falls Hospital
        • Principal Investigator:
          • Julian R. Sprague
        • Contact:
          • Site Public Contact
          • Phone Number: 518-926-6700
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Principal Investigator:
          • Craig S. Sauter
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
      • Rochester, New York, United States, 14642
        • Recruiting
        • University of Rochester
        • Contact:
          • Site Public Contact
          • Phone Number: 585-275-5830
        • Principal Investigator:
          • Paul M. Barr
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • UNC Lineberger Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Anne W. Beaven
      • Charlotte, North Carolina, United States, 28203
        • Recruiting
        • Carolinas Medical Center/Levine Cancer Institute
        • Principal Investigator:
          • Nilanjan Ghosh
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-9376
      • Charlotte, North Carolina, United States, 28210
        • Recruiting
        • Atrium Health Pineville/LCI-Pineville
        • Principal Investigator:
          • Nilanjan Ghosh
        • Contact:
          • Site Public Contact
          • Phone Number: 980-442-2000
      • Clemmons, North Carolina, United States, 27012
        • Recruiting
        • Wake Forest University at Clemmons
        • Principal Investigator:
          • Rakhee Vaidya
        • Contact:
          • Site Public Contact
          • Phone Number: 888-716-9259
      • Concord, North Carolina, United States, 28025
        • Recruiting
        • Atrium Health Cabarrus/LCI-Concord
        • Principal Investigator:
          • Nilanjan Ghosh
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-9376
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 888-275-3853
        • Principal Investigator:
          • Jeffrey Crawford
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest University Health Sciences
        • Principal Investigator:
          • Rakhee Vaidya
        • Contact:
          • Site Public Contact
          • Phone Number: 336-713-6771
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • University of Cincinnati/Barrett Cancer Center
        • Principal Investigator:
          • Tahir Latif
        • Contact:
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Foundation
        • Contact:
        • Principal Investigator:
          • Brian T. Hill
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • Case Western Reserve University
        • Principal Investigator:
          • Kirsten M. Boughan
        • Contact:
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University Comprehensive Cancer Center
        • Principal Investigator:
          • Kami J. Maddocks
        • Contact:
      • West Chester, Ohio, United States, 45069
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma Health Sciences Center
        • Contact:
        • Principal Investigator:
          • Mohamad Khawandanah
    • Oregon
      • Baker City, Oregon, United States, 97814
        • Recruiting
        • Saint Alphonsus Medical Center-Baker City
        • Contact:
        • Principal Investigator:
          • John M. Schallenkamp
      • Bend, Oregon, United States, 97701
        • Recruiting
        • Saint Charles Health System
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Clackamas, Oregon, United States, 97015
        • Recruiting
        • Providence Cancer Institute Clackamas Clinic
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Clackamas, Oregon, United States, 97015
        • Recruiting
        • Clackamas Radiation Oncology Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Coos Bay, Oregon, United States, 97420
        • Recruiting
        • Bay Area Hospital
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Newberg, Oregon, United States, 97132
        • Recruiting
        • Providence Newberg Medical Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Ontario, Oregon, United States, 97914
        • Recruiting
        • Saint Alphonsus Medical Center-Ontario
        • Contact:
        • Principal Investigator:
          • John M. Schallenkamp
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health and Science University
        • Principal Investigator:
          • Sarah J. Nagle
        • Contact:
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence Portland Medical Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Providence Saint Vincent Medical Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Redmond, Oregon, United States, 97756
        • Recruiting
        • Saint Charles Health System-Redmond
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
          • Site Public Contact
          • Phone Number: 541-706-2909
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Recruiting
        • Geisinger Medical Center
        • Contact:
        • Principal Investigator:
          • Joseph J. Vadakara
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania/Abramson Cancer Center
        • Principal Investigator:
          • James N. Gerson
        • Contact:
          • Site Public Contact
          • Phone Number: 800-474-9892
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • University of Pittsburgh Cancer Institute (UPCI)
        • Principal Investigator:
          • Kathleen A. Dorritie
        • Contact:
          • Site Public Contact
          • Phone Number: 412-647-8073
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
        • Principal Investigator:
          • Brian T. Hess
      • Clinton, South Carolina, United States, 29325
        • Recruiting
        • Prisma Health Cancer Institute - Laurens
        • Principal Investigator:
          • Jeffrey K. Giguere
        • Contact:
      • Easley, South Carolina, United States, 29640
        • Recruiting
        • Prisma Health Cancer Institute - Easley
        • Principal Investigator:
          • Jeffrey K. Giguere
        • Contact:
      • Greenville, South Carolina, United States, 29601
        • Recruiting
        • Saint Francis Hospital
        • Contact:
        • Principal Investigator:
          • Robert D. Siegel
      • Greenville, South Carolina, United States, 29605
        • Recruiting
        • Prisma Health Cancer Institute - Faris
        • Principal Investigator:
          • Jeffrey K. Giguere
        • Contact:
      • Greenville, South Carolina, United States, 29607
        • Recruiting
        • Saint Francis Cancer Center
        • Contact:
        • Principal Investigator:
          • Robert D. Siegel
      • Greenville, South Carolina, United States, 29605
        • Recruiting
        • Prisma Health Cancer Institute - Butternut
        • Principal Investigator:
          • Jeffrey K. Giguere
        • Contact:
      • Greenville, South Carolina, United States, 29615
        • Recruiting
        • Prisma Health Cancer Institute - Eastside
        • Principal Investigator:
          • Jeffrey K. Giguere
        • Contact:
      • Greenville, South Carolina, United States, 29605
        • Recruiting
        • Prisma Health Greenville Memorial Hospital
        • Principal Investigator:
          • Jeffrey K. Giguere
        • Contact:
      • Greer, South Carolina, United States, 29650
        • Recruiting
        • Prisma Health Cancer Institute - Greer
        • Principal Investigator:
          • Jeffrey K. Giguere
        • Contact:
      • Seneca, South Carolina, United States, 29672
        • Recruiting
        • Prisma Health Cancer Institute - Seneca
        • Principal Investigator:
          • Jeffrey K. Giguere
        • Contact:
      • Spartanburg, South Carolina, United States, 29307
        • Recruiting
        • Prisma Health Cancer Institute - Spartanburg
        • Principal Investigator:
          • Jeffrey K. Giguere
        • Contact:
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University/Ingram Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-811-8480
        • Principal Investigator:
          • Bhagirathbhai Dholaria
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Houston Methodist Hospital
        • Principal Investigator:
          • Sai Ravi Kiran Pingali
        • Contact:
          • Site Public Contact
          • Phone Number: 713-790-2700
      • Houston, Texas, United States, 77070
        • Suspended
        • Methodist Willowbrook Hospital
      • Sugar Land, Texas, United States, 77479
        • Suspended
        • Houston Methodist Sugar Land Hospital
    • Utah
      • American Fork, Utah, United States, 84003
        • Suspended
        • American Fork Hospital / Huntsman Intermountain Cancer Center
      • Cedar City, Utah, United States, 84720
        • Suspended
        • Sandra L Maxwell Cancer Center
      • Farmington, Utah, United States, 84025
        • Recruiting
        • Farmington Health Center
        • Contact:
        • Principal Investigator:
          • Deborah M. Stephens
      • Logan, Utah, United States, 84321
        • Suspended
        • Logan Regional Hospital
      • Murray, Utah, United States, 84107
        • Suspended
        • Intermountain Medical Center
      • Ogden, Utah, United States, 84403
        • Suspended
        • McKay-Dee Hospital Center
      • Provo, Utah, United States, 84604
        • Suspended
        • Utah Valley Regional Medical Center
      • Riverton, Utah, United States, 84065
        • Suspended
        • Riverton Hospital
      • Saint George, Utah, United States, 84770
        • Suspended
        • Dixie Medical Center Regional Cancer Center
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • Huntsman Cancer Institute/University of Utah
        • Contact:
        • Principal Investigator:
          • Deborah M. Stephens
      • Salt Lake City, Utah, United States, 84106
        • Suspended
        • Utah Cancer Specialists-Salt Lake City
      • Salt Lake City, Utah, United States, 84143
        • Suspended
        • LDS Hospital
      • South Jordan, Utah, United States, 84009
        • Recruiting
        • South Jordan Health Center
        • Contact:
        • Principal Investigator:
          • Deborah M. Stephens
    • Vermont
      • Berlin, Vermont, United States, 05602
        • Recruiting
        • Central Vermont Medical Center/National Life Cancer Treatment
        • Principal Investigator:
          • Julian R. Sprague
        • Contact:
          • Site Public Contact
          • Phone Number: 802-225-5400
      • Burlington, Vermont, United States, 05401
        • Recruiting
        • University of Vermont Medical Center
        • Principal Investigator:
          • Julian R. Sprague
        • Contact:
          • Site Public Contact
          • Phone Number: 802-656-4101
          • Email: rpo@uvm.edu
      • Burlington, Vermont, United States, 05405
        • Recruiting
        • University of Vermont and State Agricultural College
        • Principal Investigator:
          • Julian R. Sprague
        • Contact:
          • Site Public Contact
          • Phone Number: 802-656-8990
          • Email: rpo@uvm.edu
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia Cancer Center
        • Principal Investigator:
          • Craig A. Portell
        • Contact:
    • Washington
      • Aberdeen, Washington, United States, 98520
        • Recruiting
        • Providence Regional Cancer System-Aberdeen
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Auburn, Washington, United States, 98001
        • Suspended
        • MultiCare Auburn Medical Center
      • Bellevue, Washington, United States, 98004
        • Recruiting
        • Overlake Hospital Medical Center
        • Principal Investigator:
          • John A. Ellerton
        • Contact:
      • Bellingham, Washington, United States, 98225
        • Recruiting
        • PeaceHealth Saint Joseph Medical Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Centralia, Washington, United States, 98531
        • Recruiting
        • Providence Regional Cancer System-Centralia
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Edmonds, Washington, United States, 98026
        • Recruiting
        • Swedish Cancer Institute-Edmonds
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Everett, Washington, United States, 98201
        • Recruiting
        • Providence Regional Cancer Partnership
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Gig Harbor, Washington, United States, 98335
        • Suspended
        • MultiCare Gig Harbor Medical Park
      • Issaquah, Washington, United States, 98029
        • Recruiting
        • Swedish Cancer Institute-Issaquah
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Kennewick, Washington, United States, 99336
        • Recruiting
        • Kadlec Clinic Hematology and Oncology
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Lacey, Washington, United States, 98503
        • Recruiting
        • Providence Regional Cancer System-Lacey
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Longview, Washington, United States, 98632
        • Recruiting
        • PeaceHealth Saint John Medical Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Port Townsend, Washington, United States, 98368
        • Suspended
        • Jefferson Healthcare
      • Puyallup, Washington, United States, 98372
        • Suspended
        • MultiCare Good Samaritan Hospital
      • Renton, Washington, United States, 98055
        • Recruiting
        • Valley Medical Center
        • Principal Investigator:
          • John A. Ellerton
        • Contact:
      • Seattle, Washington, United States, 98195
        • Recruiting
        • University of Washington Medical Center
        • Principal Investigator:
          • Brian G. Till
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-8824
      • Seattle, Washington, United States, 98107
        • Recruiting
        • Swedish Medical Center-Ballard Campus
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Fred Hutchinson Cancer Research Center
        • Principal Investigator:
          • Brian G. Till
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-8824
      • Seattle, Washington, United States, 98112
        • Active, not recruiting
        • Kaiser Permanente Washington
      • Seattle, Washington, United States, 98122-5711
        • Recruiting
        • Swedish Medical Center-Cherry Hill
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Seattle Cancer Care Alliance
        • Principal Investigator:
          • Brian G. Till
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-8824
      • Seattle, Washington, United States, 98122-4307
        • Recruiting
        • Swedish Medical Center-First Hill
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Seattle, Washington, United States, 98104
        • Recruiting
        • Pacific Gynecology Specialists
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Sedro-Woolley, Washington, United States, 98284
        • Recruiting
        • PeaceHealth United General Medical Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Shelton, Washington, United States, 98584
        • Recruiting
        • Providence Regional Cancer System-Shelton
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Spokane, Washington, United States, 99204
        • Suspended
        • MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
      • Spokane, Washington, United States, 99218
        • Suspended
        • MultiCare Deaconess Cancer and Blood Specialty Center - North
      • Spokane Valley, Washington, United States, 99216
        • Suspended
        • MultiCare Deaconess Cancer and Blood Specialty Center - Valley
      • Tacoma, Washington, United States, 98405
        • Suspended
        • MultiCare Tacoma General Hospital
      • Tacoma, Washington, United States, 98405
        • Suspended
        • Mary Bridge Children's Hospital and Health Center
      • Vancouver, Washington, United States, 98664
        • Recruiting
        • PeaceHealth Southwest Medical Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Walla Walla, Washington, United States, 99362
        • Recruiting
        • Providence Saint Mary Regional Cancer Center
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
      • Yelm, Washington, United States, 98597
        • Recruiting
        • Providence Regional Cancer System-Yelm
        • Principal Investigator:
          • Alison K. Conlin
        • Contact:
    • West Virginia
      • Bridgeport, West Virginia, United States, 26330
        • Recruiting
        • United Hospital Center
        • Contact:
        • Principal Investigator:
          • Lauren W. Veltri
      • Martinsburg, West Virginia, United States, 25401
        • Recruiting
        • WVUH-Berkely Medical Center
        • Contact:
        • Principal Investigator:
          • Lauren W. Veltri
      • Morgantown, West Virginia, United States, 26506
        • Recruiting
        • West Virginia University Healthcare
        • Contact:
        • Principal Investigator:
          • Lauren W. Veltri
      • Parkersburg, West Virginia, United States, 26101
        • Recruiting
        • Camden Clark Medical Center
        • Contact:
        • Principal Investigator:
          • Lauren W. Veltri
    • Wisconsin
      • Chippewa Falls, Wisconsin, United States, 54729
      • Eau Claire, Wisconsin, United States, 54701
      • Eau Claire, Wisconsin, United States, 54701
        • Active, not recruiting
        • Mayo Clinic Health System-Eau Claire Clinic
      • Green Bay, Wisconsin, United States, 54301
        • Recruiting
        • Saint Vincent Hospital Cancer Center Green Bay
        • Contact:
        • Principal Investigator:
          • Brian L. Burnette
      • Green Bay, Wisconsin, United States, 54303
        • Recruiting
        • Saint Vincent Hospital Cancer Center at Saint Mary's
        • Contact:
        • Principal Investigator:
          • Brian L. Burnette
      • La Crosse, Wisconsin, United States, 54601
        • Recruiting
        • Gundersen Lutheran Medical Center
        • Contact:
        • Principal Investigator:
          • Kurt Oettel
      • Ladysmith, Wisconsin, United States, 54848
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University of Wisconsin Hospital and Clinics
        • Principal Investigator:
          • Vaishalee P. Kenkre
        • Contact:
          • Site Public Contact
          • Phone Number: 800-622-8922
      • Marshfield, Wisconsin, United States, 54449
      • Marshfield, Wisconsin, United States, 54449
        • Suspended
        • Marshfield Medical Center
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College Of Wisconsin
        • Principal Investigator:
          • Timothy S. Fenske
        • Contact:
          • Site Public Contact
          • Phone Number: 414-805-3666
      • Minocqua, Wisconsin, United States, 54548
      • Mukwonago, Wisconsin, United States, 53149
        • Recruiting
        • ProHealth D N Greenwald Center
        • Contact:
        • Principal Investigator:
          • Timothy R. Wassenaar
      • Oconomowoc, Wisconsin, United States, 53066
        • Recruiting
        • ProHealth Oconomowoc Memorial Hospital
        • Principal Investigator:
          • Timothy R. Wassenaar
        • Contact:
          • Site Public Contact
          • Phone Number: 262-928-7878
      • Oconto Falls, Wisconsin, United States, 54154
        • Recruiting
        • Saint Vincent Hospital Cancer Center at Oconto Falls
        • Contact:
        • Principal Investigator:
          • Brian L. Burnette
      • Rice Lake, Wisconsin, United States, 54868
      • Stevens Point, Wisconsin, United States, 54482
      • Sturgeon Bay, Wisconsin, United States, 54235-1495
        • Recruiting
        • Saint Vincent Hospital Cancer Center at Sturgeon Bay
        • Contact:
        • Principal Investigator:
          • Brian L. Burnette
      • Waukesha, Wisconsin, United States, 53188
        • Recruiting
        • ProHealth Waukesha Memorial Hospital
        • Principal Investigator:
          • Timothy R. Wassenaar
        • Contact:
          • Site Public Contact
          • Phone Number: 262-928-7632
      • Waukesha, Wisconsin, United States, 53188
        • Recruiting
        • UW Cancer Center at ProHealth Care
        • Principal Investigator:
          • Timothy R. Wassenaar
        • Contact:
      • Wausau, Wisconsin, United States, 54401
      • Weston, Wisconsin, United States, 54476
      • Wisconsin Rapids, Wisconsin, United States, 54494
    • Wyoming
      • Cheyenne, Wyoming, United States, 82001
        • Recruiting
        • Cheyenne Regional Medical Center-West
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
      • Cody, Wyoming, United States, 82414
        • Recruiting
        • Billings Clinic-Cody
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Sheridan, Wyoming, United States, 82801
        • Recruiting
        • Welch Cancer Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:

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 to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • INCLUSION CRITERIA FOR SCREENING (STEP 0 - PREREGISTRATION)
  • Patients must have histologically confirmed mantle cell lymphoma, with cyclin D1 by immunohistochemical stains and/or t(11;14) by cytogenetics or FISH. If patient has cyclin D1 negative mantle cell lymphoma with classical morphology and an expression profile (including SOX11+) that is otherwise indistinguishable from mantle cell lymphoma, communication with investigator is required for consideration of enrollment. The proliferation rate, using Ki-67 or MIB-1, should also be determined, but is not required until Step 1 registration. Patients may register to Step 0 without a documented Ki-67 index.
  • Patients should be deemed to be potentially eligible and willing candidates for auto-HCT by the enrolling physician

  • Patient may be receiving or have completed induction therapy within 60 days prior to preregistration to step 0; no more than 300 days may have passed between the first day of induction therapy and preregistration to step 0

    • For patients who have completed induction therapy, restaging evaluation must show status of partial (PR) or complete response (CR); patients preregistered post-induction with evidence of clinical disease progression are not eligible for preregistration

    • Up to two regimens of chemotherapy are allowed as long as a continuous response was ongoing throughout therapy

      • NOTE: For example, a patient who started treatment with rituximab/bendamustine and was then switched to rituximab(R)-cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone (CHOP) (due to insufficient response or excessive toxicity) would be counted as having received 2 regimens; however, R-CHOP alternating with R-dexamethasone, high-dose cytarabine, and cisplatin (DHAP) as a planned induction regimen would count as one regimen
  • Patient does not have any documented history of central nervous system (CNS) involvement by mantle cell lymphoma; this includes no evidence of parenchymal brain, spinal cord, or cerebrospinal fluid involvement; radiculopathy symptoms from nerve root compression by lymphoma do not constitute CNS involvement

  • Patient must have archived formalin-fixed paraffin-embedded (FFPE) tumor tissue specimen from the original diagnostic biopsy available for submission to Adaptive Biotechnologies for ClonoSEQ ID molecular marker identification of unique clonal immunoglobulin deoxyribonucleic acid (DNA) sequence

    • NOTE: Patients for whom the molecular marker is identified will have peripheral blood collected after completion of induction (patient?s disease status is PR or CR) and submitted to Adaptive Biotechnologies for minimal residual disease (MRD) assessment
  • INCLUSION CRITERIA FOR TREATMENT ASSIGNMENT (STEP 1)
  • Patients must have met eligibility criteria for the screening step

  • Institution has received results from Adaptive Biotechnologies as defined by one of the following criteria:

    • Patients are ?MRD Indeterminate?: ClonoSEQ ID molecular marker assessment did not identify any unique clonal immunoglobulin DNA sequence OR
    • ClonoSEQ ID molecular marker assessment identified unique clonal immunoglobulin DNA sequence and MRD assessment is completed

  • Patients must have completed induction therapy within 120 days prior to preregistration to step 0, AND no more than 300 days may have elapsed from the first dose of induction chemotherapy (cycle 1 [C1] day 1 [D1]) given, until the last day of induction chemotherapy administered; for those assigned to Arms A, C, or D, the date of transplant (?day 0?) must not be greater than 365 days after the first dose of induction chemotherapy (C1D1) given

    • Patient must have received at least four (4) cycles of induction therapy

    • Up to two regimens of chemotherapy are allowed as long as a continuous response was ongoing throughout therapy

      • NOTE: For example, a patient who started treatment with rituximab/bendamustine and was then switched to R-CHOP (due to insufficient response or excessive toxicity) would be counted as having received 2 regimens; however, R-CHOP alternating with R-DHAP as a planned induction regimen would count as one regimen
  • Patients must have achieved a radiologic complete or partial remission as defined by the Lugano criteria
  • Patients must meet institutional eligibility requirements for stem cell transplant, including cardiac, renal, liver, and pulmonary requirements
  • Patients have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

  • Human immunodeficiency virus (HIV) positive patients are not excluded, but to enroll, must meet all of the below criteria:

    • HIV is sensitive to antiretroviral therapy
    • Must be willing to take effective antiretroviral therapy if indicated
    • CD4 count at screening >= 300 cells/mm^3
    • No history of acquired immune deficiency syndrome (AIDS)-defining conditions
  • Patient must be disease-free >= 3 years of prior malignancies with the exception of adequately treated non-melanoma skin cancer, adequately treated in situ carcinoma, low grade prostate carcinoma (Gleason grade =< 6) managed with observation that has been stable for at least 6 months

  • Women must not be pregnant or breast-feeding

    • All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy
    • A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
  • Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study

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
Experimental: Group I (auto-HCT, rituximab)
Patients receive standard of care preparative chemotherapy and undergo auto-HCT. Beginning 60-120 days after transplant, patients receive rituximab IV once every 8 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Correlative studies
Biological: Rituximab
Given IV
Procedure: Autologous Hematopoietic Stem Cell Transplantation
Undergo HCT
Other Names:
  • Autologous Hematopoietic Cell Transplantation
  • autologous stem cell transplantation
Experimental: Group II (rituximab alone)
Patients receive standard of care induction chemotherapy. Beginning 40-120 days after completion of chemotherapy, patients receive rituximab as in Group I.
Other: Laboratory Biomarker Analysis
Correlative studies
Biological: Rituximab
Given IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS) in MCL patients in MRD-negative first remission who undergo auto-HCT followed by rituximab vs. maintenance rituximab alone
Time Frame: Time between randomization and death from any cause, assessed up to 10 years
The Kaplan-Meier method will be used to estimate OS, including medians and confidence intervals. Comparison of OS between treatment arms will be conducted using a one-sided log-rank test stratified with mantle cell lymphoma International Prognostic Index (MIPI)-c score and induction regimen.
Time between randomization and death from any cause, assessed up to 10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Time Frame: Up to 10 years
The primary safety analysis will be based on the toxicity population, and the analysis will be performed by treatment received.
Up to 10 years
MRD status in MCL patients who were MRD-positive prior to auto-HCT
Time Frame: At 100 days
Will be reported together with confidence intervals.
At 100 days
OS in MRD-positive patients (or patients in PR) who undergo auto-HCT followed by rituximab
Time Frame: Time between randomization and death from any cause, assessed up to 10 years
Will be estimated by the method of Kaplan and Meier.
Time between randomization and death from any cause, assessed up to 10 years
PFS in MRD-positive patients (or patients in PR) who undergo auto-HCT followed by rituximab
Time Frame: From randomization to the earliest of documented disease progression or death without progression, assessed up to 10 years
Will be estimated by the method of Kaplan and Meier.
From randomization to the earliest of documented disease progression or death without progression, assessed up to 10 years
Progression-free survival (PFS) in MCL patients in MRD-negative first remission who undergo auto-HCT followed by rituximab vs rituximab alone
Time Frame: From randomization to the earliest of documented disease progression or death without progression, assessed up to 10 years
The method of Kaplan and Meier will be used to estimate PFS, and stratified log-rank test will be used to compare PFS between two arms.
From randomization to the earliest of documented disease progression or death without progression, assessed up to 10 years
Rate of complications in MCL patients undergoing maintenance rituximab
Time Frame: Up to 10 years
Up to 10 years

Collaborators and Investigators

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

Sponsor

ECOG-ACRIN Cancer Research Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Timothy Fenske, ECOG-ACRIN Cancer Research Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 6, 2018

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

January 31, 2032

Study Registration Dates

First Submitted

August 28, 2017

First Submitted That Met QC Criteria

August 29, 2017

First Posted (Actual)

August 30, 2017

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 21, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EA4151 (Other Identifier: CTEP)
  • U10CA180820 (U.S. NIH Grant/Contract)
  • NCI-2016-01403 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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