Pembrolizumab and Dasatinib, Imatinib Mesylate, or Nilotinib in Treating Patients With Chronic Myeloid Leukemia and Persistently Detectable Minimal Residual Disease

November 27, 2023 updated by: ECOG-ACRIN Cancer Research Group

Phase II Study of Adding the Anti-PD-1 Pembrolizumab to Tyrosine Kinase Inhibitors in Patients With Chronic Myeloid Leukemia and Persistently Detectable Minimal Residual Disease

This phase II trial studies how well pembrolizumab and dasatinib, imatinib mesylate, or nilotinib work in treating patients with chronic myeloid leukemia and persistent detection of minimal residual disease, defined as the levels of a gene product called bcr-abl in the blood. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of cancer cells to grow and spread. Dasatinib, imatinib mesylate, and nilotinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and dasatinib, imatinib mesylate, or nilotinib may work better in treating patients with chronic myeloid leukemia.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. Assess the proportion of chronic myelogenous leukemia (CML) patients on stable-dose tyrosine kinase inhibitor (TKI) who convert to undetectable minimal residual disease (UMRD) (molecular response [MR]^4.5) during or within 2 years of initiating pembrolizumab therapy.

SECONDARY OBJECTIVES:

I. Among patients who have converted to UMRD (MR^4.5), assess the proportion of CML patients who maintain UMRD for 6 months and 12 months.

II. Among patients who have converted to UMRD (MR^4.5), assess the proportion of CML patients who discontinue their TKI.

III. Among patients who have converted to UMRD (MR^4.5), assess the proportion of CML patients who are UMRD and TKI-free at 2 years from first determined UMRD.

IV. Assess the proportion of CML patients who develop grade 3 or 4 immune related adverse events related to pembrolizumab treatment during the first 2 years after registration (not including grade 3 events that respond to corticosteroids and improve to grade 1 or less within 4 weeks).

OUTLINE:

Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1 and dasatinib, imatinib mesylate, or nilotinib orally (PO) as clinically indicated per the treating physician. Treatment repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity. Patients with detectable MRD after course 18 continue pembrolizumab and dasatinib, imatinib mesylate, or nilotinib every 21 days for up to an additional 18 courses in the absence of disease progression or unacceptable toxicity. Patients with UMRD at any time before course 18 discontinue pembrolizumab after course 18 and continue dasatinib, imatinib mesylate, or nilotinib every 21 days for up to an additional 18 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months for 6 years from the date of registration.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2

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
    • Arizona
      • Goodyear, Arizona, United States, 85338
        • Active, not recruiting
        • CTCA at Western Regional Medical Center
      • Phoenix, Arizona, United States, 85004
        • Recruiting
        • Cancer Center at Saint Joseph's
        • Contact:
          • Site Public Contact
          • Phone Number: 602-406-8222
        • Principal Investigator:
          • Richard L. Deming
    • Arkansas
      • Fort Smith, Arkansas, United States, 72903
        • Recruiting
        • Mercy Hospital Fort Smith
        • Contact:
          • Site Public Contact
          • Phone Number: 800-378-9373
        • Principal Investigator:
          • Jay W. Carlson
      • Hot Springs, Arkansas, United States, 71913
        • Recruiting
        • CHI Saint Vincent Cancer Center Hot Springs
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
    • California
      • Arroyo Grande, California, United States, 93420
        • Recruiting
        • Mission Hope Medical Oncology - Arroyo Grande
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • San Luis Obispo, California, United States, 93401
      • Santa Maria, California, United States, 93444
        • Recruiting
        • Mission Hope Medical Oncology - Santa Maria
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Recruiting
        • Penrose-Saint Francis Healthcare
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • Colorado Springs, Colorado, United States, 80907
        • Recruiting
        • Rocky Mountain Cancer Centers-Penrose
        • Contact:
        • Principal Investigator:
          • Richard L. Deming
      • Denver, Colorado, United States, 80210
        • Recruiting
        • Porter Adventist Hospital
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • Durango, Colorado, United States, 81301
        • Recruiting
        • Mercy Medical Center
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • Durango, Colorado, United States, 81301
        • Recruiting
        • Southwest Oncology PC
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • Golden, Colorado, United States, 80401
        • Suspended
        • Mountain Blue Cancer Care Center
      • Lakewood, Colorado, United States, 80228
        • Suspended
        • Rocky Mountain Cancer Centers-Lakewood
      • Lakewood, Colorado, United States, 80228
        • Recruiting
        • Saint Anthony Hospital
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • Littleton, Colorado, United States, 80122
        • Recruiting
        • Littleton Adventist Hospital
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • Longmont, Colorado, United States, 80501
        • Recruiting
        • Longmont United Hospital
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • Longmont, Colorado, United States, 80501
        • Recruiting
        • Rocky Mountain Cancer Centers-Longmont
        • Contact:
        • Principal Investigator:
          • Richard L. Deming
      • Parker, Colorado, United States, 80138
        • Recruiting
        • Parker Adventist Hospital
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • Parker, Colorado, United States, 80138
        • Suspended
        • Rocky Mountain Cancer Centers-Parker
      • Pueblo, Colorado, United States, 81004
        • Recruiting
        • Saint Mary Corwin Medical Center
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • Pueblo, Colorado, United States, 81008
        • Suspended
        • Rocky Mountain Cancer Centers - Pueblo
      • Thornton, Colorado, United States, 80260
        • Suspended
        • Rocky Mountain Cancer Centers-Thornton
    • Connecticut
      • Derby, Connecticut, United States, 06418
        • Recruiting
        • Smilow Cancer Hospital-Derby Care Center
        • Principal Investigator:
          • Amer M. Zeidan
        • Contact:
      • Fairfield, Connecticut, United States, 06824
        • Recruiting
        • Smilow Cancer Hospital Care Center-Fairfield
        • Principal Investigator:
          • Amer M. Zeidan
        • Contact:
      • Guilford, Connecticut, United States, 06437
        • Recruiting
        • Smilow Cancer Hospital Care Center - Guiford
        • Principal Investigator:
          • Amer M. Zeidan
        • Contact:
      • Hartford, Connecticut, United States, 06105
        • Recruiting
        • Smilow Cancer Hospital Care Center at Saint Francis
        • Principal Investigator:
          • Amer M. Zeidan
        • Contact:
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Smilow Cancer Center/Yale-New Haven Hospital
        • Principal Investigator:
          • Amer M. Zeidan
        • Contact:
      • North Haven, Connecticut, United States, 06473
        • Recruiting
        • Yale-New Haven Hospital North Haven Medical Center
        • Principal Investigator:
          • Amer M. Zeidan
        • Contact:
      • Torrington, Connecticut, United States, 06790
        • Recruiting
        • Smilow Cancer Hospital-Torrington Care Center
        • Principal Investigator:
          • Amer M. Zeidan
        • Contact:
      • Trumbull, Connecticut, United States, 06611
        • Recruiting
        • Smilow Cancer Hospital Care Center-Trumbull
        • Principal Investigator:
          • Amer M. Zeidan
        • Contact:
      • Waterbury, Connecticut, United States, 06708
        • Recruiting
        • Smilow Cancer Hospital-Waterbury Care Center
        • Principal Investigator:
          • Amer M. Zeidan
        • Contact:
      • Waterford, Connecticut, United States, 06385
        • Recruiting
        • Smilow Cancer Hospital Care Center - Waterford
        • Principal Investigator:
          • Amer M. Zeidan
        • Contact:
    • Delaware
      • Frankford, Delaware, United States, 19945
        • Active, not recruiting
        • Beebe South Coastal Health Campus
      • Lewes, Delaware, United States, 19958
        • Active, not recruiting
        • Beebe Medical Center
      • Newark, Delaware, United States, 19713
        • Active, not recruiting
        • Helen F Graham Cancer Center
      • Newark, Delaware, United States, 19713
        • Active, not recruiting
        • Medical Oncology Hematology Consultants PA
      • Newark, Delaware, United States, 19713
        • Active, not recruiting
        • Delaware Clinical and Laboratory Physicians PA
      • Newark, Delaware, United States, 19718
        • Active, not recruiting
        • Christiana Care Health System-Christiana Hospital
      • Rehoboth Beach, Delaware, United States, 19971
        • Active, not recruiting
        • Beebe Health Campus
      • Seaford, Delaware, United States, 19973
        • Active, not recruiting
        • TidalHealth Nanticoke / Allen Cancer Center
      • Wilmington, Delaware, United States, 19801
        • Active, not recruiting
        • Christiana Care Health System-Wilmington Hospital
    • Idaho
      • Boise, Idaho, United States, 83706
        • Recruiting
        • Saint Alphonsus Cancer Care Center-Boise
        • Contact:
        • Principal Investigator:
          • John M. Schallenkamp
      • 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
      • Meridian, Idaho, United States, 83642
        • Recruiting
        • Idaho Urologic Institute-Meridian
        • Contact:
        • Principal Investigator:
          • John M. Schallenkamp
      • Nampa, Idaho, United States, 83686
        • Recruiting
        • Saint Alphonsus Medical Center-Nampa
        • Contact:
        • Principal Investigator:
          • John M. Schallenkamp
      • 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:
    • Illinois
      • Aurora, Illinois, United States, 60504
        • Recruiting
        • Rush - Copley Medical Center
        • Contact:
        • Principal Investigator:
          • Priyank P. Patel
      • Bloomington, Illinois, United States, 61704
        • Recruiting
        • Illinois CancerCare-Bloomington
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Canton, Illinois, United States, 61520
        • Recruiting
        • Illinois CancerCare-Canton
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Carbondale, Illinois, United States, 62902
        • Recruiting
        • Memorial Hospital of Carbondale
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Carterville, Illinois, United States, 62918
        • Recruiting
        • SIH Cancer Institute
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Carthage, Illinois, United States, 62321
        • Recruiting
        • Illinois CancerCare-Carthage
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Centralia, Illinois, United States, 62801
        • Recruiting
        • Centralia Oncology Clinic
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Principal Investigator:
          • Jessica K. Altman
        • Contact:
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • University of Illinois
        • Principal Investigator:
          • Irum Khan
        • Contact:
          • Site Public Contact
          • Phone Number: 312-355-3046
      • Danville, Illinois, United States, 61832
        • Recruiting
        • Carle on Vermilion
        • Contact:
        • Principal Investigator:
          • Priyank P. Patel
      • Decatur, Illinois, United States, 62526
        • Recruiting
        • Cancer Care Specialists of Illinois - Decatur
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Decatur, Illinois, United States, 62526
        • Recruiting
        • Decatur Memorial Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Dixon, Illinois, United States, 61021
        • Recruiting
        • Illinois CancerCare-Dixon
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 815-285-7800
      • Effingham, Illinois, United States, 62401
        • Recruiting
        • Carle Physician Group-Effingham
        • Contact:
        • Principal Investigator:
          • Priyank P. Patel
      • Effingham, Illinois, United States, 62401
        • Recruiting
        • Crossroads Cancer Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Eureka, Illinois, United States, 61530
        • Recruiting
        • Illinois CancerCare-Eureka
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Galesburg, Illinois, United States, 61401
        • Recruiting
        • Illinois CancerCare-Galesburg
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Galesburg, Illinois, United States, 61401
        • Recruiting
        • Western Illinois Cancer Treatment Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 309-344-2831
      • Kewanee, Illinois, United States, 61443
        • Recruiting
        • Illinois CancerCare-Kewanee Clinic
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Lake Forest, Illinois, United States, 60045
        • Recruiting
        • Northwestern Medicine Lake Forest Hospital
        • Principal Investigator:
          • Jessica K. Altman
        • Contact:
      • Macomb, Illinois, United States, 61455
        • Recruiting
        • Illinois CancerCare-Macomb
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Mattoon, Illinois, United States, 61938
        • Recruiting
        • Carle Physician Group-Mattoon/Charleston
        • Contact:
        • Principal Investigator:
          • Priyank P. Patel
      • 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
      • O'Fallon, Illinois, United States, 62269
        • Recruiting
        • Cancer Care Center of O'Fallon
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Ottawa, Illinois, United States, 61350
        • Recruiting
        • Illinois CancerCare-Ottawa Clinic
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Pekin, Illinois, United States, 61554
        • Recruiting
        • Illinois CancerCare-Pekin
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Peoria, Illinois, United States, 61615
        • Recruiting
        • Illinois CancerCare-Peoria
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Peoria, Illinois, United States, 61636
        • Recruiting
        • Methodist Medical Center of Illinois
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Peru, Illinois, United States, 61354
        • Recruiting
        • Illinois CancerCare-Peru
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Peru, Illinois, United States, 61354
        • Recruiting
        • Valley Radiation Oncology
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 815-664-4141
      • Princeton, Illinois, United States, 61356
        • Recruiting
        • Illinois CancerCare-Princeton
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • 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
        • Recruiting
        • Memorial Medical Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 217-788-3528
      • Swansea, Illinois, United States, 62226
        • Suspended
        • Southwest Illinois Health Services LLP
      • Urbana, Illinois, United States, 61801
        • Recruiting
        • Carle Cancer Center
        • Contact:
        • Principal Investigator:
          • Priyank P. Patel
      • Urbana, Illinois, United States, 61801
        • Recruiting
        • The Carle Foundation Hospital
        • Contact:
        • Principal Investigator:
          • Priyank P. Patel
      • Yorkville, Illinois, United States, 60560
        • Recruiting
        • Rush-Copley Healthcare Center
        • Contact:
        • Principal Investigator:
          • Priyank P. Patel
    • Iowa
      • Ames, Iowa, United States, 50010
        • Recruiting
        • Mary Greeley Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 515-956-4132
        • Principal Investigator:
          • Debra M. Prow
      • Ames, Iowa, United States, 50010
        • Recruiting
        • McFarland Clinic PC - Ames
        • Principal Investigator:
          • Debra M. Prow
        • Contact:
      • Boone, Iowa, United States, 50036
        • Recruiting
        • McFarland Clinic PC-Boone
        • Contact:
          • Site Public Contact
          • Phone Number: 515-956-4132
        • Principal Investigator:
          • Debra M. Prow
      • Clive, Iowa, United States, 50325
        • Recruiting
        • Medical Oncology and Hematology Associates-West Des Moines
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • Clive, Iowa, United States, 50325
        • Recruiting
        • Mercy Cancer Center-West Lakes
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • Council Bluffs, Iowa, United States, 51503
        • Recruiting
        • Alegent Health Mercy Hospital
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • Creston, Iowa, United States, 50801
        • Recruiting
        • Greater Regional Medical Center
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • Des Moines, Iowa, United States, 50309
        • Recruiting
        • Medical Oncology and Hematology Associates-Des Moines
        • Contact:
          • Site Public Contact
          • Phone Number: 515-282-2921
        • Principal Investigator:
          • Robert J. Behrens
      • Des Moines, Iowa, United States, 50314
        • Recruiting
        • Broadlawns Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 515-282-2200
        • Principal Investigator:
          • Robert J. Behrens
      • Des Moines, Iowa, United States, 50314
        • Recruiting
        • Mercy Medical Center - Des Moines
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • Des Moines, Iowa, United States, 50309
        • Recruiting
        • Iowa Methodist Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-6727
        • Principal Investigator:
          • Robert J. Behrens
      • Des Moines, Iowa, United States, 50316
        • Recruiting
        • Iowa Lutheran Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-8704
        • Principal Investigator:
          • Robert J. Behrens
      • Des Moines, Iowa, United States, 50314
        • Recruiting
        • Medical Oncology and Hematology Associates-Laurel
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • Fort Dodge, Iowa, United States, 50501
        • Recruiting
        • McFarland Clinic PC-Trinity Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 515-956-4132
        • Principal Investigator:
          • Debra M. Prow
      • Fort Dodge, Iowa, United States, 50501
        • Recruiting
        • Trinity Regional Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 515-574-8302
        • Principal Investigator:
          • Robert J. Behrens
      • Jefferson, Iowa, United States, 50129
        • Recruiting
        • McFarland Clinic PC-Jefferson
        • Contact:
          • Site Public Contact
          • Phone Number: 515-956-4132
        • Principal Investigator:
          • Debra M. Prow
      • Marshalltown, Iowa, United States, 50158
        • Recruiting
        • McFarland Clinic PC-Marshalltown
        • Contact:
          • Site Public Contact
          • Phone Number: 515-956-4132
        • Principal Investigator:
          • Debra M. Prow
      • West Des Moines, Iowa, United States, 50266
        • Recruiting
        • Mercy Medical Center-West Lakes
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • West Des Moines, Iowa, United States, 50266-7700
        • Recruiting
        • Methodist West Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 515-343-1000
        • Principal Investigator:
          • Robert J. Behrens
    • Kansas
      • Lawrence, Kansas, United States, 66044
        • Suspended
        • Lawrence Memorial Hospital
      • 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
      • Wichita, Kansas, United States, 67214
        • Recruiting
        • Wesley Medical Center
        • Contact:
        • Principal Investigator:
          • Shaker R. Dakhil
    • Kentucky
      • Bardstown, Kentucky, United States, 40004
        • Recruiting
        • Flaget Memorial Hospital
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • Corbin, Kentucky, United States, 40701
        • Recruiting
        • Commonwealth Cancer Center-Corbin
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • Lexington, Kentucky, United States, 40509
        • Recruiting
        • Saint Joseph Hospital East
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • Lexington, Kentucky, United States, 40504
        • Recruiting
        • Saint Joseph Radiation Oncology Resource Center
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • London, Kentucky, United States, 40741
        • Recruiting
        • Saint Joseph London
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • Jewish Hospital
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • Louisville, Kentucky, United States, 40215
        • Recruiting
        • Saints Mary and Elizabeth Hospital
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • Louisville, Kentucky, United States, 40245
        • Recruiting
        • Jewish Hospital Medical Center Northeast
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • Shepherdsville, Kentucky, United States, 40165
        • Recruiting
        • Jewish Hospital Medical Center South
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21229
        • Recruiting
        • Saint Agnes Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 410-368-2910
        • Principal Investigator:
          • Carole B. Miller
    • Michigan
      • Adrian, Michigan, United States, 49221
        • Recruiting
        • Hickman Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 517-265-0116
        • Principal Investigator:
          • Rex B. Mowat
      • Monroe, Michigan, United States, 48162
        • Recruiting
        • Toledo Clinic Cancer Centers-Monroe
        • Principal Investigator:
          • Rex B. Mowat
        • Contact:
          • Site Public Contact
          • Phone Number: 800-444-3561
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic in Rochester
        • Principal Investigator:
          • Mark R. Litzow
        • Contact:
          • Site Public Contact
          • Phone Number: 855-776-0015
      • Saint Cloud, Minnesota, United States, 56303
        • Recruiting
        • Coborn Cancer Center at Saint Cloud Hospital
        • Contact:
        • Principal Investigator:
          • Donald J. Jurgens
    • Missouri
      • Ballwin, Missouri, United States, 63011
        • Recruiting
        • Saint Louis Cancer and Breast Institute-Ballwin
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 314-251-7058
      • Bonne Terre, Missouri, United States, 63628
        • Suspended
        • Parkland Health Center-Bonne Terre
      • Branson, Missouri, United States, 65616
        • Suspended
        • Cox Cancer Center Branson
      • 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
        • Recruiting
        • Southeast Cancer Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 573-651-5550
      • 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
        • Recruiting
        • Capital Region Southwest Campus
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Joplin, Missouri, United States, 64804
        • Recruiting
        • Freeman Health System
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Joplin, Missouri, United States, 64804
        • Recruiting
        • Mercy Hospital Joplin
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Rolla, Missouri, United States, 65401
        • Recruiting
        • Delbert Day Cancer Institute at PCRMC
        • Contact:
        • Principal Investigator:
          • Jay W. Carlson
      • Rolla, Missouri, United States, 65401
        • Recruiting
        • Mercy Clinic-Rolla-Cancer and Hematology
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 573-458-6379
      • Saint Joseph, Missouri, United States, 64506
        • Recruiting
        • Heartland Regional Medical Center
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • 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
        • Recruiting
        • Saint Louis Cancer and Breast Institute-South City
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 314-353-1870
      • Saint Louis, Missouri, United States, 63128
        • Recruiting
        • Mercy Hospital South
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • 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
        • Recruiting
        • Mercy Hospital Springfield
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 417-269-4520
      • Springfield, Missouri, United States, 65807
        • Recruiting
        • CoxHealth South Hospital
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 417-269-4520
      • 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
        • Missouri Baptist Outpatient Center-Sunset Hills
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Washington, Missouri, United States, 63090
        • Recruiting
        • Mercy Hospital Washington
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 636-390-1600
    • 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:
      • 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
        • 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:
    • Nebraska
      • Bellevue, Nebraska, United States, 68123
        • Recruiting
        • Nebraska Medicine-Bellevue
        • Principal Investigator:
          • Vijaya R. Bhatt
        • Contact:
      • Grand Island, Nebraska, United States, 68803
        • Recruiting
        • CHI Health Saint Francis
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • Kearney, Nebraska, United States, 68847
        • Recruiting
        • CHI Health Good Samaritan
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • Kearney, Nebraska, United States, 68845
        • Suspended
        • Heartland Hematology and Oncology
      • Lincoln, Nebraska, United States, 68510
        • Recruiting
        • Saint Elizabeth Regional Medical Center
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • University of Nebraska Medical Center
        • Principal Investigator:
          • Vijaya R. Bhatt
        • Contact:
      • Omaha, Nebraska, United States, 68118
        • Recruiting
        • Nebraska Medicine-Village Pointe
        • Principal Investigator:
          • Vijaya R. Bhatt
        • Contact:
          • Site Public Contact
          • Phone Number: 402-559-5600
      • Omaha, Nebraska, United States, 68122
        • Recruiting
        • Alegent Health Immanuel Medical Center
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • Omaha, Nebraska, United States, 68122
        • Suspended
        • Hematology and Oncology Consultants PC
      • Omaha, Nebraska, United States, 68124
        • Recruiting
        • Alegent Health Bergan Mercy Medical Center
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • Omaha, Nebraska, United States, 68130
        • Recruiting
        • Alegent Health Lakeside Hospital
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • Omaha, Nebraska, United States, 68131
        • Recruiting
        • Creighton University Medical Center
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • Papillion, Nebraska, United States, 68046
        • Recruiting
        • Midlands Community Hospital
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Recruiting
        • Morristown Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 973-971-5900
        • Principal Investigator:
          • Charles M. Farber
    • New York
      • Middletown, New York, United States, 10940
        • Recruiting
        • Garnet Health Medical Center
        • Contact:
        • Principal Investigator:
          • Jeffrey M. Stewart
    • North Carolina
      • Clinton, North Carolina, United States, 28328
        • Recruiting
        • Southeastern Medical Oncology Center-Clinton
        • Contact:
        • Principal Investigator:
          • Samer S. Kasbari
      • Goldsboro, North Carolina, United States, 27534
        • Recruiting
        • Southeastern Medical Oncology Center-Goldsboro
        • Contact:
        • Principal Investigator:
          • Samer S. Kasbari
      • Goldsboro, North Carolina, United States, 27534
        • Active, not recruiting
        • Wayne Memorial Hospital
      • Jacksonville, North Carolina, United States, 28546
        • Active, not recruiting
        • Onslow Memorial Hospital
      • Jacksonville, North Carolina, United States, 28546
        • Recruiting
        • Southeastern Medical Oncology Center-Jacksonville
        • Principal Investigator:
          • Samer S. Kasbari
        • Contact:
    • Ohio
      • Cincinnati, Ohio, United States, 45220
        • Recruiting
        • Good Samaritan Hospital - Cincinnati
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • Cincinnati, Ohio, United States, 45242
        • Recruiting
        • Bethesda North Hospital
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • Cincinnati, Ohio, United States, 45247
        • Recruiting
        • TriHealth Cancer Institute-Westside
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • Cincinnati, Ohio, United States, 45255
        • Recruiting
        • TriHealth Cancer Institute-Anderson
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • Cleveland, Ohio, United States, 44109
        • Recruiting
        • MetroHealth Medical Center
        • Contact:
        • Principal Investigator:
          • William Tse
      • Perrysburg, Ohio, United States, 43551
        • Suspended
        • Mercy Health Perrysburg Cancer Center
      • Toledo, Ohio, United States, 43623
        • Recruiting
        • Mercy Health - Saint Anne Hospital
        • Principal Investigator:
          • Rex B. Mowat
        • Contact:
      • 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
    • Oklahoma
      • Lawton, Oklahoma, United States, 73505
        • Recruiting
        • Cancer Centers of Southwest Oklahoma Research
        • Contact:
          • Site Public Contact
          • Phone Number: 877-231-4440
        • Principal Investigator:
          • Mohamad Khawandanah
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma Health Sciences Center
        • Contact:
        • Principal Investigator:
          • Mohamad Khawandanah
      • Oklahoma City, Oklahoma, United States, 73120
        • Recruiting
        • Mercy Hospital Oklahoma City
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 405-752-3402
      • Tulsa, Oklahoma, United States, 74146
        • Recruiting
        • Oklahoma Cancer Specialists and Research Institute-Tulsa
        • Contact:
          • Site Public Contact
          • Phone Number: 918-505-3200
        • Principal Investigator:
          • Mohamad Khawandanah
    • Oregon
      • Baker City, Oregon, United States, 97814
        • Recruiting
        • Saint Alphonsus Medical Center-Baker City
        • Contact:
        • Principal Investigator:
          • John M. Schallenkamp
      • Ontario, Oregon, United States, 97914
        • Recruiting
        • Saint Alphonsus Medical Center-Ontario
        • Contact:
        • Principal Investigator:
          • John M. Schallenkamp
    • Pennsylvania
      • Chadds Ford, Pennsylvania, United States, 19317
        • Active, not recruiting
        • Christiana Care Health System-Concord Health Center
      • Danville, Pennsylvania, United States, 17822
        • Recruiting
        • Geisinger Medical Center
        • Contact:
        • Principal Investigator:
          • Joseph J. Vadakara
      • Hazleton, Pennsylvania, United States, 18201
        • Recruiting
        • Geisinger Medical Center-Cancer Center Hazleton
        • Contact:
        • Principal Investigator:
          • Joseph J. Vadakara
      • Lewisburg, Pennsylvania, United States, 17837
        • Recruiting
        • Geisinger Medical Oncology-Lewisburg
        • Contact:
        • Principal Investigator:
          • Joseph J. Vadakara
      • Lewistown, Pennsylvania, United States, 17044
        • Recruiting
        • Lewistown Hospital
        • Contact:
        • Principal Investigator:
          • Joseph J. Vadakara
      • Pottsville, Pennsylvania, United States, 17901
        • Recruiting
        • Geisinger Cancer Services-Pottsville
        • Contact:
        • Principal Investigator:
          • Joseph J. Vadakara
      • Scranton, Pennsylvania, United States, 18510
        • Recruiting
        • Community Medical Center
        • Contact:
        • Principal Investigator:
          • Joseph J. Vadakara
      • Selinsgrove, Pennsylvania, United States, 17870
        • Recruiting
        • Geisinger Medical Oncology-Selinsgrove
        • Contact:
        • Principal Investigator:
          • Joseph J. Vadakara
      • State College, Pennsylvania, United States, 16801
        • Recruiting
        • Geisinger Medical Group
        • Contact:
        • Principal Investigator:
          • Joseph J. Vadakara
      • Wilkes-Barre, Pennsylvania, United States, 18711
        • Recruiting
        • Geisinger Wyoming Valley/Henry Cancer Center
        • Contact:
        • Principal Investigator:
          • Joseph J. Vadakara
    • South Carolina
      • Boiling Springs, South Carolina, United States, 29316
        • Recruiting
        • Prisma Health Cancer Institute - Spartanburg
        • Principal Investigator:
          • Jeffrey K. Giguere
        • Contact:
      • 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, 29605
        • Recruiting
        • BI-LO Charities Children's Cancer Center
        • Principal Investigator:
          • Jeffrey K. Giguere
        • Contact:
      • Greenville, South Carolina, United States, 29605
        • Recruiting
        • Prisma Health Cancer Institute - Faris
        • Principal Investigator:
          • Jeffrey K. Giguere
        • Contact:
      • 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:
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Suspended
        • Memorial Hospital
      • Hixson, Tennessee, United States, 37343
        • Suspended
        • Pulmonary Medicine Center of Chattanooga-Hixson
      • Ooltewah, Tennessee, United States, 37363
        • Suspended
        • Memorial GYN Plus
    • Texas
      • Bryan, Texas, United States, 77802
        • Recruiting
        • Saint Joseph Regional Cancer Center
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
    • Virginia
      • Martinsville, Virginia, United States, 24115
        • Recruiting
        • Sovah Health Martinsville
        • Contact:
        • Principal Investigator:
          • Mohammed Saad
    • Washington
      • Bremerton, Washington, United States, 98310
        • Recruiting
        • Harrison HealthPartners Hematology and Oncology-Bremerton
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • Bremerton, Washington, United States, 98310
        • Recruiting
        • Harrison Medical Center
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • Burien, Washington, United States, 98166
        • Recruiting
        • Highline Medical Center-Main Campus
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • Enumclaw, Washington, United States, 98022
        • Recruiting
        • Saint Elizabeth Hospital
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • Federal Way, Washington, United States, 98003
        • Recruiting
        • Saint Francis Hospital
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • Lakewood, Washington, United States, 98499
        • Recruiting
        • Saint Clare Hospital
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • Poulsbo, Washington, United States, 98370
        • Recruiting
        • Harrison HealthPartners Hematology and Oncology-Poulsbo
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • Tacoma, Washington, United States, 98405
        • Recruiting
        • Franciscan Research Center-Northwest Medical Plaza
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • Tacoma, Washington, United States, 98405
        • Recruiting
        • Northwest Medical Specialties PLLC
        • Contact:
        • Principal Investigator:
          • Richard L. Deming
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Recruiting
        • West Virginia University Healthcare
        • Principal Investigator:
          • Kelly G. Ross
        • Contact:
    • Wisconsin
      • Eau Claire, Wisconsin, United States, 54701
      • Eau Claire, Wisconsin, United States, 54701
        • Recruiting
        • Mayo Clinic Health System-Eau Claire Clinic
        • Principal Investigator:
          • Mark R. Litzow
        • Contact:
          • Site Public Contact
          • Phone Number: 855-776-0015
      • Eau Claire, Wisconsin, United States, 54703
        • Recruiting
        • Mayo Clinic Health System Eau Claire Hospital-Luther Campus
        • Principal Investigator:
          • Mark R. Litzow
        • Contact:
          • Site Public Contact
          • Phone Number: 855-776-0015
      • Ladysmith, Wisconsin, United States, 54848
      • Marshfield, Wisconsin, United States, 54449
      • Minocqua, Wisconsin, United States, 54548
      • Rice Lake, Wisconsin, United States, 54868
      • Stevens Point, Wisconsin, United States, 54482
      • Wausau, Wisconsin, United States, 54401
      • Weston, Wisconsin, United States, 54476
      • Wisconsin Rapids, Wisconsin, United States, 54494
    • Wyoming
      • 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • PREREGISTRATION (STEP 0): Patient has pathologically-confirmed chronic phase-CML on a first line TKI and must meet the following criteria:

    • The patient has to be on first-line TKI therapy (the same TKI) for at least 2 years prior to pre-registration
    • Has been in MMR (i.e. MR^3) but still have detectable BCR-ABL transcript by a standard real-time quantitative polymerase chain reaction (RQ-PCR) assay with a limit of detection (sensitivity) of 4.5 for at least 12 months from the first documentation of the MMR
    • Patient has not achieved MR^4.5 (complete molecular remission [CMR]) within the time of initiation of TKI therapy and pre-registration
  • PREREGISTRATION (STEP 0): Patient must be scheduled to undergo a standard of care bone marrow biopsy within 7 days of step 0 registration
  • PREREGISTRATION (STEP 0): Peripheral blood must be collected for submission to Fred Hutchinson Cancer Research Center for central assessment of the establishment of BCR/ABL status to confirm patient?s eligibility for registration to Step 1; Fred Hutchinson will forward results within 1-2 business days of receipt of the peripheral blood to the submitting institution
  • REGISTRATION TO TREATMENT (STEP 1): Institution has received central BCR-ABL test results confirming MRD positive status
  • REGISTRATION TO TREATMENT (STEP 1): Patients have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • REGISTRATION TO TREATMENT (STEP 1): No active hemolytic anemia requiring immunosuppressive therapy or other pharmacologic treatment; patients who have a positive Coombs test but no evidence of hemolysis are NOT excluded from participation
  • REGISTRATION TO TREATMENT (STEP 1): No current use of corticosteroids; EXCEPTION: Low doses of steroids (< 10 mg of prednisone or equivalent dose of other steroid) used for treatment of non-hematologic medical condition (e.g. chronic adrenal insufficiency) is permitted

  • REGISTRATION TO TREATMENT (STEP 1): No other active primary malignancy (other than non-melanomatous skin cancer or carcinoma in situ of the cervix) requiring treatment or limiting expected survival to =< 2 years

    • NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment (other than hormonal therapy for their cancer)
  • REGISTRATION TO TREATMENT (STEP 1): Women must not be pregnant or breastfeeding; patients must also not expect to conceive or father children from the time of registration, while on study treatment, and continue for 120 days after the last dose of study treatment; all females of childbearing potential must have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of pembrolizumab; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required; 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)
  • REGISTRATION TO TREATMENT (STEP 1): Women of childbearing potential and sexually active males must use an accepted and effective method of contraception or to abstain from sexual from time of registration, while on study treatment, and continue for 120 days after the last dose of study treatment
  • REGISTRATION TO TREATMENT (STEP 1): Patients must have been on a stable dose of the TKI for the last 3 months prior to pre-registration
  • REGISTRATION TO TREATMENT (STEP 1): Patient may not be currently participating and receiving study therapy or have participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment
  • REGISTRATION TO TREATMENT (STEP 1): Patient must not have a diagnosis of immunodeficiency or be receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of treatment
  • REGISTRATION TO TREATMENT (STEP 1): Patient must not have a known history of active TB (Bacillus Tuberculosis)
  • REGISTRATION TO TREATMENT (STEP 1): Patient must not have a history of hypersensitivity to pembrolizumab or any of its excipients
  • REGISTRATION TO TREATMENT (STEP 1): Patient must not have received a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study registration or have not recovered (i.e., =< grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier

  • REGISTRATION TO TREATMENT (STEP 1): Patient must not have had prior chemotherapy, targeted small molecule therapy (aside from imatinib, dasatinib, or nilotinib), or radiation therapy within 2 weeks prior to study registration; patients also must have recovered from all adverse events due to a previously administered agent

    • Note: Patients with =< grade 2 neuropathy are an exception to this criterion and may qualify for the study
  • REGISTRATION TO TREATMENT (STEP 1): Patients who have received major surgery must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy
  • REGISTRATION TO TREATMENT (STEP 1): Patient must not have a known additional malignancy that is progressing or requires active treatment; exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer
  • REGISTRATION TO TREATMENT (STEP 1): Patient must not have known active central nervous system (CNS) metastases and/or carcinomatous meningitis; subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of protocol treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to protocol treatment; this exception does not include carcinomatous meningitis which is excluded regardless of clinical stability
  • REGISTRATION TO TREATMENT (STEP 1): Patient must not have active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs); replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
  • REGISTRATION TO TREATMENT (STEP 1): Patient must not have known history of, or any evidence of active, non-infectious pneumonitis
  • REGISTRATION TO TREATMENT (STEP 1): Patient must not have an active infection requiring systemic therapy
  • REGISTRATION TO TREATMENT (STEP 1): Patient must not have a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
  • REGISTRATION TO TREATMENT (STEP 1): Patient must not have known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
  • REGISTRATION TO TREATMENT (STEP 1): Patient must not have received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent
  • REGISTRATION TO TREATMENT (STEP 1): Patients who are Human Immunodeficiency Virus (HIV) positive are eligible if they have undetectable HIV viral load and CD4+ T-cell count ≥ 250/mm3.
  • REGISTRATION TO TREATMENT (STEP 1): Patients with a known positive test for Hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection might be enrolled if the viral load by PCR is undetectable with/without active treatment.
  • REGISTRATION TO TREATMENT (STEP 1): Patients must not have known history of hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive).

  • REGISTRATION TO TREATMENT (STEP 1): Patient must not have received a live vaccine within 30 days of planned start of study therapy

    • NOTE: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed
  • REGISTRATION TO TREATMENT (STEP 1): Absolute neutrophil count (ANC) >= 1,500 /mcL, within 14 days prior to first dose of pembrolizumab
  • REGISTRATION TO TREATMENT (STEP 1): Platelet count >= 100,000 /mcL, within 14 days prior to first dose of pembrolizumab
  • REGISTRATION TO TREATMENT (STEP 1): Hemoglobin (Hgb) >= 9 g/dL OR >= 5.6 mmol/L without transfusion of erythropoietin (EPO) dependency, within 14 days prior to first dose of pembrolizumab
  • REGISTRATION TO TREATMENT (STEP 1): Serum creatinine =< 1.5 X upper limit of normal (ULN) OR creatinine clearance (per institutional standards) >= 60 mL/min for patient with creatinine levels > 1.5 X ULN, within 14 days prior to first dose of pembrolizumab

  • REGISTRATION TO TREATMENT (STEP 1): Serum total bilirubin =< 1.5 X ULN OR direct bilirubin

    =< ULN for subjects with total bilirubin levels > 1.5 X ULN, within 14 days prior to first dose of pembrolizumab

  • REGISTRATION TO TREATMENT (STEP 1): Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 2.5 X ULN OR =< 5 X ULN for subjects with liver metastases, within 14 days prior to first dose of pembrolizumab
  • REGISTRATION TO TREATMENT (STEP 1): Patients should not be receiving concomitant strong CYP3A4 inducers or inhibitors ≤ 7 days prior to registration due to their potential to effect the activity or pharmacokinetics of study agents and/or QT interval prolongation toxicity. Should treatment with any of these agents be required, consult with study chair.
  • REGISTRATION TO TREATMENT (STEP 1): Patients should not have received prior allogeneic transplant.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment (pembrolizumab, dasatinib, imatinib, nilotinib)
Patients receive pembrolizumab IV over 30 minutes on day 1 and dasatinib, imatinib mesylate, or nilotinib PO as clinically indicated per the treating physician. Treatment repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity. Patients with detectable MRD after course 18 continue pembrolizumab and dasatinib, imatinib mesylate, or nilotinib every 21 days for up to an additional 18 courses in the absence of disease progression or unacceptable toxicity. Patients with UMRD at any time before course 18 discontinue pembrolizumab after course 18 and continue dasatinib, imatinib mesylate, or nilotinib every 21 days for up to an additional 18 courses in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Correlative studies
Drug: Nilotinib
Given PO
Other Names:
  • AMN 107
  • Tasigna
Drug: Dasatinib
Given PO
Other Names:
  • BMS-354825
  • Sprycel
Biological: Pembrolizumab
Given IV
Other Names:
  • Keytruda
  • MK-3475
  • Lambrolizumab
  • SCH 900475
Drug: Imatinib Mesylate
Given PO
Other Names:
  • Gleevec
  • CGP 57148
  • CGP57148B
  • Glivec
  • STI 571
  • STI-571
  • STI571

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients on tyrosine kinase inhibitor (TKI) who convert to undetectable minimal residual disease (UMRD)
Time Frame: Up to 2 years of initiating pembrolizumab
Will be reported with exact confidence intervals. The binomial test will be used to test the null hypothesis that this proportion is 0.2 with the alternative hypothesis being that this proportion is greater than 0.2.
Up to 2 years of initiating pembrolizumab

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients who maintain UMRD for 6 months
Time Frame: Up to 6 years
Will be assessed among patients who achieve UMRD within two years of initiating pembrolizumab. The proportions will be reported with exact confidence intervals.
Up to 6 years
Proportion of patients who maintain UMRD for 6 and 12 months
Time Frame: Up to 6 years
Will be assessed among patients who achieve UMRD within two years of initiating pembrolizumab. The proportions will be reported with exact confidence intervals.
Up to 6 years
Proportion of patients who meet the criteria for discontinuing TKI
Time Frame: Up to 6 years
Will be assessed among patients who achieve and maintain UMRD within two years of initiating pembrolizumab. The proportions will be reported with exact confidence intervals.
Up to 6 years
Proportion of patients who maintain UMRD for 2 years after first achieving UMRD
Time Frame: Up to 6 years
Will be assessed among patients who have converted to UMRD (molecular response [MR]^4.5) and discontinued TKI. The proportions will be reported with exact confidence intervals.
Up to 6 years
Proportion of patients who develop grade 3 or 4 immune related adverse events (not including grade 3 events that respond to corticosteroids and improve to grade 1 or less within 4 weeks)
Time Frame: Up to 6 years
Will be tabulated based on grade Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Up to 6 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: Amer Zeidan, ECOG-ACRIN Cancer Research Group

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)

June 26, 2019

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

August 31, 2031

Study Registration Dates

First Submitted

April 24, 2018

First Submitted That Met QC Criteria

April 24, 2018

First Posted (Actual)

May 4, 2018

Study Record Updates

Last Update Posted (Actual)

November 28, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EA9171 (Other Identifier: CTEP)
  • U10CA180820 (U.S. NIH Grant/Contract)
  • NCI-2017-02161 (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

product manufactured in and exported from the U.S.

Yes

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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