- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04799275
Testing CC-486 (Oral Azacitidine) Plus the Standard Drug Therapy in Patients 75 Years or Older With Newly Diagnosed Diffuse Large B Cell Lymphoma
A Phase II/III Randomized Study of R-MiniCHOP With or Without CC-486 (Oral Azacitidine) in Participants Age 75 Years or Older With Newly Diagnosed Diffuse Large B Cell Lymphoma, Grade IIIB Follicular Lymphoma, Transformed Lymphoma, and High-Grade B-Cell Lymphomas With MYC AND BCL2 and/or BCL6 Rearrangements
Study Overview
Status
Conditions
- Lymphoplasmacytic Lymphoma
- Ann Arbor Stage III Diffuse Large B-Cell Lymphoma
- Ann Arbor Stage IV Diffuse Large B-Cell Lymphoma
- High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
- High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements
- Grade 3b Follicular Lymphoma
- Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
- EBV-Positive Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
- High Grade B-Cell Lymphoma, Not Otherwise Specified
- Diffuse Large B-Cell Lymphoma Associated With Chronic Inflammation
- Primary Cutaneous Diffuse Large B-Cell Lymphoma, Leg Type
- Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma
- Intravascular Large B-Cell Lymphoma
- T-Cell/Histiocyte-Rich Large B-Cell Lymphoma
- High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements
- Diffuse Large B-Cell Lymphoma Activated B-Cell Type
- Diffuse Large B-Cell Lymphoma Germinal Center B-Cell Type
- HHV8-Positive Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
- Transformed Marginal Zone Lymphoma to Diffuse Large B-Cell Lymphoma
- Ann Arbor Stage IIX (Bulky) Diffuse Large B-Cell Lymphoma
- Nodular Lymphocyte Predominant B-Cell Lymphoma
Detailed Description
PRIMARY OBJECTIVES:
I. To determine if the addition of CC-486 (oral azacitidine) to R-miniCHOP results in excess toxicity compared to R-miniCHOP alone that would preclude the combination from being studied further. (Safety run-in) II. To determine if the CC-486 + R-miniCHOP regimen should be tested further (Phase III) against the control R-miniCHOP alone based on progression-free survival (PFS). (Phase II component) III. To compare the overall survival (OS) between CC-486 + R-miniCHOP and R-miniCHOP alone. (Phase III component)
SECONDARY OBJECTIVES:
I. To assess the feasibility of delivering at least 4 cycles of CC-486 with R-miniCHOP in this population.
II. To assess toxicity for CC-486 + R-miniCHOP and for R-miniCHOP. III. To compare complete response rates, as defined by Lugano 2014 classification, between CC-486 + R-miniCHOP and R-miniCHOP alone.
INTEGRATED CORRELATIVE GERIATRIC ASSESSMENTS:
I. To compare functioning as assessed by the S1918 Comprehensive Geriatric Assessment (S1918 CGA) between participants treated with CC-486 + R-miniCHOP versus R-miniCHOP alone.
II. To evaluate if frailty status (fit/unfit versus [vs] frail/superfrail) as assessed by the FIL tool is associated with OS.
III. To evaluate if frailty as measured by the FIL tool correlates with the summary frailty index as measured using components of the S1918 CGA.
BANKING OBJECTIVE:
I. To bank specimens for future correlative studies.
OUTLINE:
Beginning 7 days prior to starting [protocol treatment, all patients receive vincristine sulfate intravenously (IV) on day 1, and prednisone orally (PO) daily on days 1-7.
Patients are then randomized to 1 of 2 arms.
ARM I: Patients receive CC-486 PO for 7 days prior to cycle 1. Patients then receive CC-486 PO on days 8-21. Treatment repeats every 21 days for cycles 1-5 in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab IV (or subcutaneously [SC] for cycles 2-6), cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 1, and prednisone PO on days 1-5. Treatment repeats every 21 days for cycles 1-6 (6 cycles total) in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive rituximab IV (or SC for cycles 2-6), cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 1, and prednisone PO on days 1-5. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically until 5 years from the date of registration.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
Arizona
-
Tucson, Arizona, United States, 85719
- Active, not recruiting
- Banner University Medical Center - Tucson
-
Tucson, Arizona, United States, 85719
- Active, not recruiting
- University of Arizona Cancer Center-North Campus
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72205
- Recruiting
- University of Arkansas for Medical Sciences
-
Contact:
- Site Public Contact
- Phone Number: 501-686-8274
-
Principal Investigator:
- Cesar Gentille
-
-
California
-
Anaheim, California, United States, 92806
- Recruiting
- Kaiser Permanente-Anaheim
-
Principal Investigator:
- Ashraf R. Aziz
-
Contact:
- Site Public Contact
- Phone Number: 800-398-3996
- Email: clinical.trials@kp.org
-
Baldwin Park, California, United States, 91706
- Recruiting
- Kaiser Permanente-Baldwin Park
-
Principal Investigator:
- Ashraf R. Aziz
-
Contact:
- Site Public Contact
- Phone Number: 800-398-3996
- Email: clinical.trials@kp.org
-
Bellflower, California, United States, 90706
- Recruiting
- Kaiser Permanente-Bellflower
-
Principal Investigator:
- Ashraf R. Aziz
-
Contact:
- Site Public Contact
- Phone Number: 800-398-3996
- Email: clinical.trials@kp.org
-
Beverly Hills, California, United States, 90211
- Recruiting
- Tower Cancer Research Foundation
-
Principal Investigator:
- Justin M. Darrah
-
Contact:
- Site Public Contact
- Email: towercancerresearch@toweroncology.com
-
Costa Mesa, California, United States, 92627
- Suspended
- UC Irvine Health Cancer Center-Newport
-
Duarte, California, United States, 91010
- Recruiting
- City of Hope Comprehensive Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 800-826-4673
- Email: becomingapatient@coh.org
-
Principal Investigator:
- Matthew Mei
-
Fontana, California, United States, 92335
- Recruiting
- Kaiser Permanente-Fontana
-
Principal Investigator:
- Ashraf R. Aziz
-
Contact:
- Site Public Contact
- Phone Number: 800-398-3996
- Email: clinical.trials@kp.org
-
Harbor City, California, United States, 90710
- Recruiting
- Kaiser Permanente - Harbor City
-
Principal Investigator:
- Ashraf R. Aziz
-
Contact:
- Site Public Contact
- Phone Number: 800-398-3996
- Email: clinical.trials@kp.org
-
Huntington Beach, California, United States, 92648
- Recruiting
- City of Hope at Huntington Beach
-
Contact:
- Site Public Contact
- Phone Number: 877-467-3411
-
Principal Investigator:
- Matthew Mei
-
Irvine, California, United States, 92618
- Recruiting
- Kaiser Permanente-Irvine
-
Principal Investigator:
- Ashraf R. Aziz
-
Contact:
- Site Public Contact
- Phone Number: 800-398-3996
- Email: clinical.trials@kp.org
-
Irvine, California, United States, 92618
- Recruiting
- City of Hope at Irvine Lennar
-
Contact:
- Site Public Contact
- Phone Number: 877-467-3411
-
Principal Investigator:
- Matthew Mei
-
Lancaster, California, United States, 93534
- Recruiting
- City of Hope Antelope Valley
-
Contact:
- Site Public Contact
- Phone Number: 800-826-4673
- Email: becomingapatient@coh.org
-
Principal Investigator:
- Matthew Mei
-
Long Beach, California, United States, 90813
- Recruiting
- City of Hope at Long Beach Elm
-
Contact:
- Site Public Contact
- Phone Number: 877-467-3411
-
Principal Investigator:
- Matthew Mei
-
Los Angeles, California, United States, 90048
- Recruiting
- Cedars Sinai Medical Center
-
Principal Investigator:
- Justin M. Darrah
-
Contact:
- Site Public Contact
- Phone Number: 310-423-8965
-
Los Angeles, California, United States, 90027
- Recruiting
- Kaiser Permanente Los Angeles Medical Center
-
Principal Investigator:
- Ashraf R. Aziz
-
Contact:
- Site Public Contact
- Phone Number: 800-398-3996
- Email: clinical.trials@kp.org
-
Los Angeles, California, United States, 90034
- Recruiting
- Kaiser Permanente West Los Angeles
-
Principal Investigator:
- Ashraf R. Aziz
-
Contact:
- Site Public Contact
- Phone Number: 800-398-3996
- Email: clinical.trials@kp.org
-
Newport Beach, California, United States, 92660
- Recruiting
- City of Hope Newport Beach
-
Contact:
- Site Public Contact
- Phone Number: 877-467-3411
-
Principal Investigator:
- Matthew Mei
-
Ontario, California, United States, 91761
- Recruiting
- Kaiser Permanente-Ontario
-
Principal Investigator:
- Ashraf R. Aziz
-
Contact:
- Site Public Contact
- Phone Number: 800-398-3996
- Email: clinical.trials@kp.org
-
Orange, California, United States, 92868
- Recruiting
- UC Irvine Health/Chao Family Comprehensive Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 877-827-8839
- Email: ucstudy@uci.edu
-
Principal Investigator:
- Elizabeth A. Brem
-
Palo Alto, California, United States, 94304
- Recruiting
- Stanford Cancer Institute Palo Alto
-
Contact:
- Site Public Contact
- Phone Number: 650-498-7061
- Email: ccto-office@stanford.edu
-
Principal Investigator:
- Ranjana H. Advani
-
Panorama City, California, United States, 91402
- Recruiting
- Kaiser Permanente - Panorama City
-
Principal Investigator:
- Ashraf R. Aziz
-
Contact:
- Site Public Contact
- Phone Number: 800-398-3996
- Email: clinical.trials@kp.org
-
Riverside, California, United States, 92505
- Recruiting
- Kaiser Permanente-Riverside
-
Principal Investigator:
- Ashraf R. Aziz
-
Contact:
- Site Public Contact
- Phone Number: 800-398-3996
- Email: clinical.trials@kp.org
-
San Diego, California, United States, 92120
- Recruiting
- Kaiser Permanente-San Diego Zion
-
Principal Investigator:
- Ashraf R. Aziz
-
Contact:
- Site Public Contact
- Phone Number: 800-398-3996
- Email: clinical.trials@kp.org
-
San Marcos, California, United States, 92078
- Recruiting
- Kaiser Permanente-San Marcos
-
Principal Investigator:
- Ashraf R. Aziz
-
Contact:
- Site Public Contact
- Phone Number: 800-398-3996
- Email: clinical.trials@kp.org
-
San Mateo, California, United States, 94402
- Recruiting
- UCSF Cancer Center - San Mateo
-
Principal Investigator:
- Bradley C. Ekstrand
-
Contact:
- Site Public Contact
- Phone Number: 877-827-3222
- Email: cancertrials@ucsf.edu
-
Upland, California, United States, 91786
- Recruiting
- City of Hope Upland
-
Contact:
- Site Public Contact
- Phone Number: 800-826-4673
- Email: becomingapatient@coh.org
-
Principal Investigator:
- Matthew Mei
-
Woodland Hills, California, United States, 91367
- Recruiting
- Kaiser Permanente-Woodland Hills
-
Principal Investigator:
- Ashraf R. Aziz
-
Contact:
- Site Public Contact
- Phone Number: 800-398-3996
- Email: clinical.trials@kp.org
-
-
Colorado
-
Golden, Colorado, United States, 80401
- Recruiting
- SCL Health Cancer Centers of Colorado - Lutheran Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 303-813-5225
- Email: Alan.miller@sclhealth.org
-
Principal Investigator:
- Karng S. Log
-
-
Delaware
-
Newark, Delaware, United States, 19713
- Recruiting
- Helen F Graham Cancer Center
-
Principal Investigator:
- Gregory A. Masters
-
Contact:
- Site Public Contact
- Phone Number: 302-623-4450
- Email: lbarone@christianacare.org
-
Newark, Delaware, United States, 19713
- Suspended
- Delaware Clinical and Laboratory Physicians PA
-
Newark, Delaware, United States, 19713
- Recruiting
- Medical Oncology Hematology Consultants PA
-
Principal Investigator:
- Gregory A. Masters
-
Contact:
- Site Public Contact
- Phone Number: 302-623-4450
- Email: lbarone@christianacare.org
-
-
Florida
-
Miami, Florida, United States, 33136
- Active, not recruiting
- University of Miami Miller School of Medicine-Sylvester Cancer Center
-
-
Georgia
-
Atlanta, Georgia, United States, 30322
- Recruiting
- Emory University Hospital/Winship Cancer Institute
-
Contact:
- Site Public Contact
- Phone Number: 404-778-1868
-
Principal Investigator:
- Jonathon B. Cohen
-
Atlanta, Georgia, United States, 30342
- Recruiting
- Emory Saint Joseph's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 404-851-7115
-
Principal Investigator:
- Jonathon B. Cohen
-
Augusta, Georgia, United States, 30912
- Recruiting
- Augusta University Medical Center
-
Principal Investigator:
- Locke J. Bryan
-
Contact:
- Site Public Contact
- Phone Number: 706-721-2388
- Email: ga_cares@augusta.edu
-
-
Hawaii
-
'Aiea, Hawaii, United States, 96701
- Recruiting
- Pali Momi Medical Center
-
Principal Investigator:
- Craig S. Boddy
-
Contact:
- Site Public Contact
- Phone Number: 808-486-6000
-
'Aiea, Hawaii, United States, 96701
- Recruiting
- Hawaii Cancer Care - Westridge
-
Principal Investigator:
- Craig S. Boddy
-
Contact:
- Site Public Contact
- Phone Number: 808-539-2273
- Email: info@hawaiicancercare.com
-
Honolulu, Hawaii, United States, 96813
- Recruiting
- Hawaii Cancer Care Inc - Waterfront Plaza
-
Principal Investigator:
- Craig S. Boddy
-
Contact:
- Site Public Contact
- Phone Number: 808-524-6115
- Email: i.webster@hawaiicancercare.com
-
Honolulu, Hawaii, United States, 96813
- Recruiting
- Queen's Cancer Cenrer - POB I
-
Principal Investigator:
- Craig S. Boddy
-
Contact:
- Site Public Contact
- Phone Number: 808-532-0315
-
Honolulu, Hawaii, United States, 96813
- Recruiting
- Queen's Medical Center
-
Principal Investigator:
- Craig S. Boddy
-
Contact:
- Site Public Contact
- Phone Number: 808-545-8548
-
Honolulu, Hawaii, United States, 96813
- Recruiting
- Straub Clinic and Hospital
-
Principal Investigator:
- Craig S. Boddy
-
Contact:
- Site Public Contact
- Phone Number: 808-522-4333
-
Honolulu, Hawaii, United States, 96817
- Recruiting
- Queen's Cancer Center - Kuakini
-
Principal Investigator:
- Craig S. Boddy
-
Contact:
- Site Public Contact
- Phone Number: 808-531-8521
-
-
Illinois
-
Chicago, Illinois, United States, 60637
- Recruiting
- University of Chicago Comprehensive Cancer Center
-
Principal Investigator:
- Sonali M. Smith
-
Contact:
- Site Public Contact
- Phone Number: 773-702-8222
- Email: cancerclinicaltrials@bsd.uchicago.edu
-
Chicago, Illinois, United States, 60611
- Recruiting
- Northwestern University
-
Contact:
- Site Public Contact
- Phone Number: 312-695-1301
- Email: cancer@northwestern.edu
-
Principal Investigator:
- Reem Karmali
-
Chicago, Illinois, United States, 60612
- Recruiting
- University of Illinois
-
Contact:
- Site Public Contact
- Phone Number: 312-355-3046
-
Principal Investigator:
- Paul G. Rubinstein
-
Danville, Illinois, United States, 61832
- Recruiting
- Carle at The Riverfront
-
Contact:
- Site Public Contact
- Phone Number: 800-446-5532
- Email: Research@carle.com
-
Principal Investigator:
- Tanmay Sahai
-
DeKalb, Illinois, United States, 60115
- Recruiting
- Northwestern Medicine Cancer Center Kishwaukee
-
Contact:
- Site Public Contact
- Phone Number: 630-352-5360
- Email: Donald.Smith3@nm.org
-
Principal Investigator:
- Reem Karmali
-
Decatur, Illinois, United States, 62526
- Recruiting
- Cancer Care Specialists of Illinois - Decatur
-
Principal Investigator:
- Bryan A. Faller
-
Contact:
- Site Public Contact
- Phone Number: 217-876-4762
- Email: morganthaler.jodi@mhsil.com
-
Decatur, Illinois, United States, 62526
- Recruiting
- Decatur Memorial Hospital
-
Principal Investigator:
- Bryan A. Faller
-
Contact:
- Site Public Contact
- Phone Number: 217-876-4762
- Email: morganthaler.jodi@mhsil.com
-
Effingham, Illinois, United States, 62401
- Recruiting
- Crossroads Cancer Center
-
Principal Investigator:
- Bryan A. Faller
-
Contact:
- Site Public Contact
- Phone Number: 217-876-4762
- Email: morganthaler.jodi@mhsil.com
-
Evanston, Illinois, United States, 60201
- Recruiting
- NorthShore University HealthSystem-Evanston Hospital
-
Principal Investigator:
- Lynne S. Kaminer
-
Contact:
- Site Public Contact
- Phone Number: 847-570-2109
-
Geneva, Illinois, United States, 60134
- Recruiting
- Northwestern Medicine Cancer Center Delnor
-
Contact:
- Site Public Contact
- Phone Number: 630-352-5360
- Email: Donald.Smith3@nm.org
-
Principal Investigator:
- Reem Karmali
-
Glenview, Illinois, United States, 60026
- Recruiting
- NorthShore University HealthSystem-Glenbrook Hospital
-
Principal Investigator:
- Lynne S. Kaminer
-
Contact:
- Site Public Contact
- Phone Number: 847-570-2109
-
Highland Park, Illinois, United States, 60035
- Recruiting
- NorthShore University HealthSystem-Highland Park Hospital
-
Principal Investigator:
- Lynne S. Kaminer
-
Contact:
- Site Public Contact
- Phone Number: 847-570-2109
-
Lake Forest, Illinois, United States, 60045
- Recruiting
- Northwestern Medicine Lake Forest Hospital
-
Principal Investigator:
- Reem Karmali
-
Contact:
- Site Public Contact
- Email: cancertrials@northwestern.edu
-
New Lenox, Illinois, United States, 60451
- Recruiting
- UC Comprehensive Cancer Center at Silver Cross
-
Principal Investigator:
- Sonali M. Smith
-
Contact:
- Site Public Contact
- Phone Number: 773-702-8222
- Email: cancerclinicaltrials@bsd.uchicago.edu
-
O'Fallon, Illinois, United States, 62269
- Recruiting
- Cancer Care Center of O'Fallon
-
Principal Investigator:
- Bryan A. Faller
-
Contact:
- Site Public Contact
- Phone Number: 217-876-4762
- Email: morganthaler.jodi@mhsil.com
-
Orland Park, Illinois, United States, 60462
- Recruiting
- University of Chicago Medicine-Orland Park
-
Principal Investigator:
- Sonali M. Smith
-
Contact:
- Site Public Contact
- Phone Number: 773-702-8222
- Email: cancerclinicaltrials@bsd.uchicago.edu
-
Peoria, Illinois, United States, 61615
- Recruiting
- Illinois CancerCare-Peoria
-
Contact:
- Site Public Contact
- Phone Number: 309-243-3605
- Email: andersonj@illinoiscancercare.com
-
Principal Investigator:
- Bryan A. Faller
-
Shiloh, Illinois, United States, 62269
- Recruiting
- Memorial Hospital East
-
Contact:
- Site Public Contact
- Phone Number: 314-747-9912
- Email: dschwab@wustl.edu
-
Principal Investigator:
- Nancy L. Bartlett
-
Urbana, Illinois, United States, 61801
- Recruiting
- Carle Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 800-446-5532
- Email: Research@carle.com
-
Principal Investigator:
- Tanmay Sahai
-
Warrenville, Illinois, United States, 60555
- Recruiting
- Northwestern Medicine Cancer Center Warrenville
-
Contact:
- Site Public Contact
- Phone Number: 630-352-5360
- Email: Donald.Smith3@nm.org
-
Principal Investigator:
- Reem Karmali
-
-
Iowa
-
Ames, Iowa, United States, 50010
- Recruiting
- McFarland Clinic - Ames
-
Principal Investigator:
- Joseph J. Merchant
-
Contact:
- Site Public Contact
- Phone Number: 515-239-4734
- Email: ksoder@mcfarlandclinic.com
-
Des Moines, Iowa, United States, 50309
- Suspended
- Iowa Methodist Medical Center
-
Des Moines, Iowa, United States, 50309
- Recruiting
- Medical Oncology and Hematology Associates-Des Moines
-
Principal Investigator:
- Joshua Lukenbill
-
Contact:
- Site Public Contact
- Phone Number: 515-241-3305
-
-
Louisiana
-
Monroe, Louisiana, United States, 71202
- Recruiting
- Ochsner LSU Health Monroe Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 318-813-1404
- Email: LPost@lsuhsc.edu
-
Principal Investigator:
- Poornima Ramadas
-
Shreveport, Louisiana, United States, 71103
- Recruiting
- LSU Health Sciences Center at Shreveport
-
Contact:
- Site Public Contact
- Phone Number: 318-813-1404
- Email: LPost@lsuhsc.edu
-
Principal Investigator:
- Poornima Ramadas
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02111
- Recruiting
- Tufts Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 617-636-5000
- Email: ContactUsCancerCenter@TuftsMedicalCenter.org
-
Principal Investigator:
- Yun Choi
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48106
- Recruiting
- Saint Joseph Mercy Hospital
-
Contact:
- Site Public Contact
- Phone Number: 734-712-7251
- Email: MCRCwebsitecontactform@stjoeshealth.org
-
Principal Investigator:
- Christopher M. Reynolds
-
Brighton, Michigan, United States, 48114
- Recruiting
- Saint Joseph Mercy Brighton
-
Contact:
- Site Public Contact
- Phone Number: 734-712-7251
- Email: MCRCwebsitecontactform@stjoeshealth.org
-
Principal Investigator:
- Christopher M. Reynolds
-
Brighton, Michigan, United States, 48114
- Recruiting
- Trinity Health IHA Medical Group Hematology Oncology - Brighton
-
Contact:
- Site Public Contact
- Phone Number: 734-712-7251
- Email: MCRCwebsitecontactform@stjoeshealth.org
-
Principal Investigator:
- Christopher M. Reynolds
-
Canton, Michigan, United States, 48188
- Recruiting
- Saint Joseph Mercy Canton
-
Contact:
- Site Public Contact
- Phone Number: 734-712-7251
- Email: MCRCwebsitecontactform@stjoeshealth.org
-
Principal Investigator:
- Christopher M. Reynolds
-
Canton, Michigan, United States, 48188
- Recruiting
- Trinity Health IHA Medical Group Hematology Oncology - Canton
-
Contact:
- Site Public Contact
- Phone Number: 734-712-7251
- Email: MCRCwebsitecontactform@stjoeshealth.org
-
Principal Investigator:
- Christopher M. Reynolds
-
Chelsea, Michigan, United States, 48118
- Recruiting
- Saint Joseph Mercy Chelsea
-
Contact:
- Site Public Contact
- Phone Number: 734-712-7251
- Email: MCRCwebsitecontactform@stjoeshealth.org
-
Principal Investigator:
- Christopher M. Reynolds
-
Chelsea, Michigan, United States, 48118
- Recruiting
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
-
Contact:
- Site Public Contact
- Phone Number: 734-712-7251
- Email: MCRCwebsitecontactform@stjoeshealth.org
-
Principal Investigator:
- Christopher M. Reynolds
-
Livonia, Michigan, United States, 48154
- Suspended
- Hope Cancer Clinic
-
Livonia, Michigan, United States, 48154
- Recruiting
- Trinity Health Saint Mary Mercy Livonia Hospital
-
Contact:
- Site Public Contact
- Phone Number: 734-712-7251
- Email: MCRCwebsitecontactform@stjoeshealth.org
-
Principal Investigator:
- Christopher M. Reynolds
-
Ypsilanti, Michigan, United States, 48106
- Recruiting
- Huron Gastroenterology PC
-
Contact:
- Site Public Contact
- Phone Number: 734-712-7251
- Email: MCRCwebsitecontactform@stjoeshealth.org
-
Principal Investigator:
- Christopher M. Reynolds
-
Ypsilanti, Michigan, United States, 48197
- Recruiting
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
-
Contact:
- Site Public Contact
- Phone Number: 734-712-7251
- Email: MCRCwebsitecontactform@stjoeshealth.org
-
Principal Investigator:
- Christopher M. Reynolds
-
-
Minnesota
-
Deer River, Minnesota, United States, 56636
- Recruiting
- Essentia Health - Deer River Clinic
-
Contact:
- Site Public Contact
- Phone Number: 218-786-3308
- Email: CancerTrials@EssentiaHealth.org
-
Principal Investigator:
- Bret E. Friday
-
Duluth, Minnesota, United States, 55805
- Recruiting
- Essentia Health Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 218-786-3308
- Email: CancerTrials@EssentiaHealth.org
-
Principal Investigator:
- Bret E. Friday
-
Hibbing, Minnesota, United States, 55746
- Recruiting
- Essentia Health Hibbing Clinic
-
Principal Investigator:
- Bret E. Friday
-
Contact:
- Site Public Contact
- Phone Number: 218-786-3308
-
Sandstone, Minnesota, United States, 55072
- Recruiting
- Essentia Health Sandstone
-
Contact:
- Site Public Contact
- Phone Number: 218-786-3308
- Email: CancerTrials@EssentiaHealth.org
-
Principal Investigator:
- Bret E. Friday
-
Virginia, Minnesota, United States, 55792
- Recruiting
- Essentia Health Virginia Clinic
-
Contact:
- Site Public Contact
- Phone Number: 218-786-3308
- Email: CancerTrials@EssentiaHealth.org
-
Principal Investigator:
- Bret E. Friday
-
-
Mississippi
-
Oxford, Mississippi, United States, 38655
- Recruiting
- Baptist Memorial Hospital and Cancer Center-Oxford
-
Contact:
- Site Public Contact
- Phone Number: 901-226-1366
- Email: BCCclintrials@bmhcc.org
-
Principal Investigator:
- Muhammad Raza
-
Southhaven, Mississippi, United States, 38671
- Recruiting
- Baptist Memorial Hospital and Cancer Center-Desoto
-
Contact:
- Site Public Contact
- Phone Number: 901-226-1366
- Email: BCCclintrials@bmhcc.org
-
Principal Investigator:
- Muhammad Raza
-
-
Missouri
-
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
-
Chesterfield, Missouri, United States, 63017
- Recruiting
- Saint Luke's Hospital
-
Principal Investigator:
- Mark J. Fesler
-
Contact:
- Site Public Contact
- Phone Number: 314-205-6936
-
Creve Coeur, Missouri, United States, 63141
- Recruiting
- Siteman Cancer Center at West County Hospital
-
Principal Investigator:
- Nancy L. Bartlett
-
Contact:
- Site Public Contact
- Phone Number: 800-600-3606
- Email: info@siteman.wustl.edu
-
Saint Louis, Missouri, United States, 63110
- Recruiting
- Washington University School of Medicine
-
Principal Investigator:
- Nancy L. Bartlett
-
Contact:
- Site Public Contact
- Phone Number: 800-600-3606
- Email: info@siteman.wustl.edu
-
Saint Louis, Missouri, United States, 63129
- Recruiting
- Siteman Cancer Center-South County
-
Principal Investigator:
- Nancy L. Bartlett
-
Contact:
- Site Public Contact
- Phone Number: 800-600-3606
- Email: info@siteman.wustl.edu
-
Saint Louis, Missouri, United States, 63136
- Recruiting
- Siteman Cancer Center at Christian Hospital
-
Principal Investigator:
- Nancy L. Bartlett
-
Contact:
- Site Public Contact
- Phone Number: 800-600-3606
- Email: info@siteman.wustl.edu
-
Saint Peters, Missouri, United States, 63376
- Recruiting
- Siteman Cancer Center at Saint Peters Hospital
-
Principal Investigator:
- Nancy L. Bartlett
-
Contact:
- Site Public Contact
- Phone Number: 800-600-3606
- Email: info@siteman.wustl.edu
-
-
Nebraska
-
Lincoln, Nebraska, United States, 68516
- Recruiting
- Cancer Partners of Nebraska - Pine Lake
-
Contact:
- Site Public Contact
- Phone Number: 402-327-7363
- Email: research@cancerpartners.com
-
Principal Investigator:
- Joni A. Tilford
-
Lincoln, Nebraska, United States, 68516
- Recruiting
- Southeast Nebraska Cancer Center - 68th Street Place
-
Contact:
- Site Public Contact
- Phone Number: 402-327-7363
- Email: research@cancerpartners.com
-
Principal Investigator:
- Joni A. Tilford
-
-
New Jersey
-
Basking Ridge, New Jersey, United States, 07920
- Recruiting
- Memorial Sloan Kettering Basking Ridge
-
Principal Investigator:
- Colette N. Owens
-
Contact:
- Site Public Contact
- Phone Number: 212-639-7592
-
Englewood, New Jersey, United States, 07631
- Active, not recruiting
- Englewood Hospital and Medical Center
-
Lakewood, New Jersey, United States, 08701
- Suspended
- Monmouth Medical Center Southern Campus
-
Long Branch, New Jersey, United States, 07740
- Suspended
- Monmouth Medical Center
-
Middletown, New Jersey, United States, 07748
- Recruiting
- Memorial Sloan Kettering Monmouth
-
Principal Investigator:
- Colette N. Owens
-
Contact:
- Site Public Contact
- Phone Number: 212-639-7592
-
Montvale, New Jersey, United States, 07645
- Recruiting
- Memorial Sloan Kettering Bergen
-
Principal Investigator:
- Colette N. Owens
-
Contact:
- Site Public Contact
- Phone Number: 212-639-7592
-
New Brunswick, New Jersey, United States, 08903
- Recruiting
- Rutgers Cancer Institute of New Jersey
-
Principal Investigator:
- Matthew J. Matasar
-
Contact:
- Site Public Contact
- Phone Number: 732-235-7356
-
Newark, New Jersey, United States, 07112
- Suspended
- Newark Beth Israel Medical Center
-
Toms River, New Jersey, United States, 08755
- Suspended
- Community Medical Center
-
-
New York
-
Buffalo, New York, United States, 14263
- Recruiting
- Roswell Park Cancer Institute
-
Principal Investigator:
- Matthew J. Cortese
-
Contact:
- Site Public Contact
- Phone Number: 800-767-9355
- Email: askroswell@roswellpark.org
-
Commack, New York, United States, 11725
- Recruiting
- Memorial Sloan Kettering Commack
-
Principal Investigator:
- Colette N. Owens
-
Contact:
- Site Public Contact
- Phone Number: 212-639-7592
-
Glens Falls, New York, United States, 12801
- Active, not recruiting
- Glens Falls Hospital
-
Harrison, New York, United States, 10604
- Recruiting
- Memorial Sloan Kettering Westchester
-
Principal Investigator:
- Colette N. Owens
-
Contact:
- Site Public Contact
- Phone Number: 212-639-7592
-
Mineola, New York, United States, 11501
- Recruiting
- NYU Winthrop Hospital
-
Contact:
- Site Public Contact
- Phone Number: 212-263-4432
- Email: cancertrials@nyulangone.org
-
Principal Investigator:
- Catherine S. Diefenbach
-
New York, New York, United States, 10032
- Recruiting
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
-
Principal Investigator:
- Jennifer E. Amengual
-
Contact:
- Site Public Contact
- Phone Number: 212-342-5162
- Email: cancerclinicaltrials@cumc.columbia.edu
-
New York, New York, United States, 10065
- Recruiting
- Memorial Sloan Kettering Cancer Center
-
Principal Investigator:
- Colette N. Owens
-
Contact:
- Site Public Contact
- Phone Number: 212-639-7592
-
New York, New York, United States, 10016
- Recruiting
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
-
Contact:
- Site Public Contact
- Email: CancerTrials@nyulangone.org
-
Principal Investigator:
- Catherine S. Diefenbach
-
New York, New York, United States, 10065
- Recruiting
- NYP/Weill Cornell Medical Center
-
Principal Investigator:
- Peter Martin
-
Contact:
- Site Public Contact
- Phone Number: 212-746-1848
-
Oswego, New York, United States, 13126
- Recruiting
- Upstate Cancer Center at Oswego
-
Contact:
- Site Public Contact
- Phone Number: 315-464-8230
- Email: McDowelE@upstate.edu
-
Principal Investigator:
- Krishna Ghimire
-
Syracuse, New York, United States, 13210
- Recruiting
- State University of New York Upstate Medical University
-
Contact:
- Site Public Contact
- Phone Number: 315-464-5476
-
Principal Investigator:
- Krishna Ghimire
-
Uniondale, New York, United States, 11553
- Recruiting
- Memorial Sloan Kettering Nassau
-
Principal Investigator:
- Colette N. Owens
-
Contact:
- Site Public Contact
- Phone Number: 212-639-7592
-
Verona, New York, United States, 13478
- Recruiting
- Upstate Cancer Center at Verona
-
Contact:
- Site Public Contact
- Phone Number: 315-464-8230
- Email: McDowelE@upstate.edu
-
Principal Investigator:
- Krishna Ghimire
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27599
- Recruiting
- UNC Lineberger Comprehensive Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 877-668-0683
- Email: cancerclinicaltrials@med.unc.edu
-
Principal Investigator:
- Anne W. Beaven
-
-
Ohio
-
Cleveland, Ohio, United States, 44195
- Recruiting
- Cleveland Clinic Foundation
-
Principal Investigator:
- Allison M. Winter
-
Contact:
- Site Public Contact
- Phone Number: 866-223-8100
- Email: TaussigResearch@ccf.org
-
Cleveland, Ohio, United States, 44111
- Recruiting
- Cleveland Clinic Cancer Center/Fairview Hospital
-
Principal Investigator:
- Allison M. Winter
-
Contact:
- Site Public Contact
- Phone Number: 866-223-8100
- Email: TaussigResearch@ccf.org
-
Columbus, Ohio, United States, 43210
- Recruiting
- Ohio State University Comprehensive Cancer Center
-
Principal Investigator:
- Yazeed Sawalha
-
Contact:
- Site Public Contact
- Phone Number: 800-293-5066
- Email: Jamesline@osumc.edu
-
Independence, Ohio, United States, 44131
- Recruiting
- Cleveland Clinic Cancer Center Independence
-
Principal Investigator:
- Allison M. Winter
-
Contact:
- Site Public Contact
- Phone Number: 866-223-8100
- Email: TaussigResearch@ccf.org
-
Mansfield, Ohio, United States, 44906
- Recruiting
- Cleveland Clinic Cancer Center Mansfield
-
Principal Investigator:
- Allison M. Winter
-
Contact:
- Site Public Contact
- Phone Number: 866-223-8100
- Email: TaussigResearch@ccf.org
-
Mayfield Heights, Ohio, United States, 44124
- Recruiting
- Hillcrest Hospital Cancer Center
-
Principal Investigator:
- Allison M. Winter
-
Contact:
- Site Public Contact
- Phone Number: 866-223-8100
- Email: TaussigResearch@ccf.org
-
Sandusky, Ohio, United States, 44870
- Recruiting
- North Coast Cancer Care
-
Principal Investigator:
- Allison M. Winter
-
Contact:
- Site Public Contact
- Phone Number: 866-223-8100
- Email: TaussigResearch@ccf.org
-
Strongsville, Ohio, United States, 44136
- Recruiting
- Cleveland Clinic Cancer Center Strongsville
-
Principal Investigator:
- Allison M. Winter
-
Contact:
- Site Public Contact
- Phone Number: 866-223-8100
- Email: TaussigResearch@ccf.org
-
Warrensville Heights, Ohio, United States, 44122
- Recruiting
- South Pointe Hospital
-
Principal Investigator:
- Allison M. Winter
-
Contact:
- Site Public Contact
- Phone Number: 866-223-8100
- Email: TaussigResearch@ccf.org
-
Wooster, Ohio, United States, 44691
- Recruiting
- Cleveland Clinic Wooster Family Health and Surgery Center
-
Principal Investigator:
- Allison M. Winter
-
Contact:
- Site Public Contact
- Phone Number: 866-223-8100
- Email: TaussigResearch@ccf.org
-
-
Oklahoma
-
Lawton, Oklahoma, United States, 73505
- Recruiting
- Cancer Centers of Southwest Oklahoma Research
-
Contact:
- Site Public Contact
- Phone Number: 877-231-4440
-
Principal Investigator:
- Sami Ibrahimi
-
Oklahoma City, Oklahoma, United States, 73104
- Recruiting
- University of Oklahoma Health Sciences Center
-
Principal Investigator:
- Sami Ibrahimi
-
Contact:
- Site Public Contact
- Phone Number: 405-271-8777
- Email: ou-clinical-trials@ouhsc.edu
-
-
Oregon
-
Portland, Oregon, United States, 97225
- Recruiting
- Providence Saint Vincent Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 503-215-2614
- Email: CanRsrchStudies@providence.org
-
Principal Investigator:
- Charles W. Drescher
-
Portland, Oregon, United States, 97239
- Recruiting
- Portland VA Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 800-949-1004
-
Principal Investigator:
- Derek Galligan
-
-
South Carolina
-
Charleston, South Carolina, United States, 29425
- Recruiting
- Medical University of South Carolina
-
Contact:
- Site Public Contact
- Phone Number: 843-792-9321
- Email: hcc-clinical-trials@musc.edu
-
Principal Investigator:
- Brian T. Hess
-
Greenville, South Carolina, United States, 29601
- Recruiting
- Saint Francis Hospital
-
Contact:
- Site Public Contact
- Phone Number: 864-603-6213
- Email: melissa_beckman@bshsi.org
-
Principal Investigator:
- Robert D. Siegel
-
Greenville, South Carolina, United States, 29607
- Recruiting
- Saint Francis Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 864-603-6213
- Email: melissa_beckman@bshsi.org
-
Principal Investigator:
- Robert D. Siegel
-
-
Tennessee
-
Memphis, Tennessee, United States, 38120
- Recruiting
- Baptist Memorial Hospital and Cancer Center-Memphis
-
Contact:
- Site Public Contact
- Phone Number: 901-226-1366
- Email: BCCclintrials@bmhcc.org
-
Principal Investigator:
- Muhammad Raza
-
-
Utah
-
Salt Lake City, Utah, United States, 84112
- Recruiting
- Huntsman Cancer Institute/University of Utah
-
Principal Investigator:
- Lindsey Fitzgerald
-
Contact:
- Site Public Contact
- Phone Number: 888-424-2100
- Email: cancerinfo@hci.utah.edu
-
-
Virginia
-
Charlottesville, Virginia, United States, 22908
- Recruiting
- University of Virginia Cancer Center
-
Principal Investigator:
- Emily Ayers
-
Contact:
- Site Public Contact
- Phone Number: 434-243-6303
- Email: uvacancertrials@hscmail.mcc.virginia.edu
-
Fairfax, Virginia, United States, 22031
- Recruiting
- Inova Schar Cancer Institute
-
Contact:
- Site Public Contact
- Phone Number: 703-720-5210
- Email: Stephanie.VanBebber@inova.org
-
Principal Investigator:
- Danielle A. Shafer
-
-
Washington
-
Bellevue, Washington, United States, 98004
- Recruiting
- FHCC Overlake
-
Contact:
- Site Public Contact
- Phone Number: 425-454-2148
-
Principal Investigator:
- Jason Comer
-
Kirkland, Washington, United States, 98034
- Recruiting
- Seattle Cancer Care Alliance at EvergreenHealth
-
Principal Investigator:
- Prakash Varadarajan
-
Contact:
- Site Public Contact
- Phone Number: 425-899-6000
-
Seattle, Washington, United States, 98133
- Recruiting
- FHCC at Northwest Hospital
-
Contact:
- Site Public Contact
- Phone Number: 206-606-5800
-
Principal Investigator:
- Paul S. Martin
-
-
West Virginia
-
Charleston, West Virginia, United States, 25304
- Recruiting
- West Virginia University Charleston Division
-
Contact:
- Site Public Contact
- Phone Number: 304-388-9944
-
Principal Investigator:
- Ahmed A. Khalid
-
-
Wisconsin
-
Ashland, Wisconsin, United States, 54806
- Recruiting
- Duluth Clinic Ashland
-
Contact:
- Site Public Contact
- Phone Number: 218-786-3308
- Email: CancerTrials@EssentiaHealth.org
-
Principal Investigator:
- Bret E. Friday
-
Eau Claire, Wisconsin, United States, 54701
- Recruiting
- Marshfield Medical Center-EC Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 800-782-8581
- Email: oncology.clinical.trials@marshfieldresearch.org
-
Principal Investigator:
- Seth O. Fagbemi
-
La Crosse, Wisconsin, United States, 54601
- Recruiting
- Gundersen Lutheran Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 608-775-2385
- Email: cancerctr@gundersenhealth.org
-
Principal Investigator:
- David E. Marinier
-
Marshfield, Wisconsin, United States, 54449
- Recruiting
- Marshfield Medical Center-Marshfield
-
Contact:
- Site Public Contact
- Phone Number: 800-782-8581
- Email: oncology.clinical.trials@marshfieldresearch.org
-
Principal Investigator:
- Seth O. Fagbemi
-
Minocqua, Wisconsin, United States, 54548
- Recruiting
- Marshfield Clinic-Minocqua Center
-
Contact:
- Site Public Contact
- Phone Number: 800-782-8581
- Email: oncology.clinical.trials@marshfieldresearch.org
-
Principal Investigator:
- Seth O. Fagbemi
-
Rice Lake, Wisconsin, United States, 54868
- Recruiting
- Marshfield Medical Center-Rice Lake
-
Contact:
- Site Public Contact
- Phone Number: 800-782-8581
- Email: oncology.clinical.trials@marshfieldresearch.org
-
Principal Investigator:
- Seth O. Fagbemi
-
Stevens Point, Wisconsin, United States, 54482
- Recruiting
- Marshfield Medical Center-River Region at Stevens Point
-
Contact:
- Site Public Contact
- Phone Number: 800-782-8581
- Email: oncology.clinical.trials@marshfieldresearch.org
-
Principal Investigator:
- Seth O. Fagbemi
-
Weston, Wisconsin, United States, 54476
- Recruiting
- Marshfield Medical Center - Weston
-
Contact:
- Site Public Contact
- Phone Number: 800-782-8581
- Email: oncology.clinical.trials@marshfieldresearch.org
-
Principal Investigator:
- Seth O. Fagbemi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participants must have histologically or cytologically confirmed diffuse large B-cell lymphoma (DLBCL), Ann Arbor Stage IIX (bulky), III or IV. Participants with DLBCL transformed from follicular lymphoma (FL) or marginal zone lymphoma (MZL, including mucosa-associated lymphoid tissue [MALT] lymphomas), lymphoplasmacytic lymphoma (LPL), or nodular lymphocyte-predominant Hodgkin Lymphoma (NLPHL) are eligible. Participants with Grade IIIB follicular lymphoma (FL) or high-grade B-cell lymphomas with MYC and BCL2 and/or BCL6 rearrangements are also eligible. Participants with DLBCL that arose from prior CLL (Richter's transformation) are not eligible.
As defined by the World Health Organization (WHO), eligible lymphoma subtypes include the following:
- DLBCL, not otherwise specified (NOS)
- DLBCL, germinal-center B-cell type (GCB)
- DLBCL, activated B-cell type (ABC)
- T-cell histiocyte-rich B-cell lymphomas (THRBCL)
- Primary cutaneous DLBCL, leg type
- Intravascular large B cell lymphoma
- EBV+ DLBCL, NOS
- DLBCL associated with chronic inflammation
- HHV8+ DLBCL, NOS
- High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements
- High grade B-cell lymphoma, NOS
- Follicular lymphoma grade 3b
- Participants must have staging imaging performed within 28 days prior to registration, as follows. Positron emission tomography (PET)-computed tomography (CT) baseline scans are strongly preferred; diagnostic quality magnetic resonance imaging (MRI), contrast-enhanced CT, or contrast-enhanced MRI scans are also acceptable if PET-CT is not feasible at baseline. Note: PET-CT will be required at end of treatment (EOT) and progression for response assessment. All measurable lesions (longest diameter >= 1.5 cm) must be assessed within 28 days prior to registration. Tests to assess non-measurable disease must be performed within 42 days prior to registration.
- Participants with known human immunodeficiency virus (HIV)-infection are eligible providing they are on effective anti-retroviral therapy and have undetectable viral load at their most recent viral load test (must be within 26 weeks prior to registration). Participants with known HIV must have a CD4 count checked within 28 days prior to registration, but may proceed with therapy regardless of CD4 count.
- All participants must be screened for chronic hepatitis B virus (HBV) within 28 days prior to registration. Participants with known HBV infection (positive serology) must also have a HBV viral load performed within 28 days prior to registration, and participants must have an undetectable HBV viral load on suppressive therapy within 28 days prior to registration. Participants found to be HBV carriers during screening are eligible and must receive standard of care prophylaxis. Participants with active hepatitis B (HBV viral load > 500 IU/mL) within 28 days prior to registration are not eligible
- Participants with a known history of hepatitis C virus (HCV) infection must have an undetectable HCV viral load within in 28 days prior to registration
- Participants must have a Zubrod performance status of 0-2
- Participants must have adequate renal function, as demonstrated by a creatinine clearance, calculated by the Cockcroft and Gault formula, of >= 30 ml/min that was obtained within 28 days prior to registration
- Aspartate aminotransferase (AST) =< 2.5 x institutional upper limit of normal (IULN), alanine aminotransferase (ALT) =< 2.5 x IULN (within 28 days prior to registration)
- Total bilirubin =< 2 x institutional upper limit of normal (IULN), unless due to Gilbert's disease, hemolysis, or lymphomatous involvement of liver (within 28 days prior to registration). Note: If total bilirubin is elevated, and direct bilirubin is subsequently performed (within 28 days prior to registration) and resulted to be =< 2 x IULN, the participant will be considered eligible
- Absolute neutrophil count (ANC) >= 1000/mcL (within 28 days prior to registration)
- Platelets >= 75,000/mcL (within 28 days prior to registration)
- Hemoglobin (Hgb) >= 8 g/ dL (within 28 days prior to registration)
If there is a documented lymphomatous involvement of the bone marrow, bone marrow function within 28 days prior to registration, as evidenced by:
- ANC >= 500/mcL
- Platelets >= 50,000/mcL
- Hemoglobin (Hgb) >= 8 g/ dL
- Participants must have a left ventricular ejection (LVEF) fraction >= 45% as measured by echocardiogram or radionuclide (multigated acquisition scan [MUGA]) ventriculography within 56 days prior to registration
For the duration of the study treatment period and for at least 4 months following the last dose of study drug, male participants must agree to use effective contraceptive methods during sexual contact with a female of childbearing potential (FCBP) and must agree to refrain from semen or sperm donation during the same timeframe. Effective contraceptive methods include a history of vasectomy, use of hormonal contraception or an intrauterine device (IUD) by the female partner, or use of condoms
- A FCBP is a sexually mature woman who: 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)
Exclusion Criteria:
- Participants must not have known lymphomatous involvement of the central nervous system (CNS)
- Participants must not have active inflammatory bowel disease (such as, Crohn's disease, ulcerative colitis), celiac disease (i.e., sprue), prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with the absorption, distribution, metabolism, or excretion of the study drug and/or predispose the subject to an increased risk of gastrointestinal toxicity
- Participants must not have received any prior cytotoxic chemotherapy or rituximab for treatment of the newly diagnosed DLBCL except for the pre-phase treatment (within specified dose range) that may have either started before or may start after registration to S1918. Inhaled, nasal, and topical steroid use is allowed. Prior cytotoxic chemotherapy and/or antibody therapy for an indolent lymphoma prior to transformation is allowed. Up to 4 doses of intrathecal (IT) chemotherapy administered for central nervous system (CNS) prophylaxis is allowed in addition to protocol therapy. High-dose intravenous methotrexate is not allowed.
- Participants must not have received more than a cumulative of dose 250 mg/m^2 of prior doxorubicin (or equivalent dose of another anthracycline, such as epirubicin) therapy (at any time prior to registration).
- Participants must not currently be receiving any other investigational agents
- Participant must not have a history of allergic reactions attributed to azacitidine, mannitol, or other hypomethylating agents
- Participants must not have active infection (systemic fungal, bacterial, or viral infection) that is not controlled (defined as ongoing signs/symptoms related the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment)
- Participants must not have active cardiac disease within 26 weeks prior to registration, including: symptomatic congestive heart failure (New York Heart Association [NYHA] class 4), unstable angina pectoris, hemodynamically unstable cardiac arrhythmia, or myocardial infarction
- Participants must not have >= grade 2 neuropathy, by Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 5.0, within 28 days prior to registration
- Participants must not have any other known uncontrolled intercurrent illness including, but not limited to ongoing psychiatric illness/social situations that would limit compliance with study requirements
Study Plan
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: Arm I (oral azacitidine, R-miniCHOP)
Patients receive CC-486 PO for 7 days prior to cycle 1.
Patients then receive CC-486 PO on days 8-21.
Treatment repeats every 21 days for cycles 1-5 in the absence of disease progression or unacceptable toxicity.
Patients also receive rituximab IV (or SC for cycles 2-6), cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 1, and prednisone PO on days 1-5.
Treatment repeats every 21 days for cycles 1-6 (6 cycles total) in the absence of disease progression or unacceptable toxicity.
|
Ancillary studies
Given IV
Other Names:
Given PO
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Given PO
Other Names:
Given IV or SC
Other Names:
|
Active Comparator: Arm II (R-miniCHOP)
Patients receive rituximab IV (or SC for cycles 2-6), cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 1, and prednisone PO on days 1-5.
Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
|
Ancillary studies
Given IV
Other Names:
Given PO
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Given IV or SC
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Excess toxicity as a result of adding oral azacitidine (CC-486) to reduced dose rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone (R-miniCHOP) (Safety run-in)
Time Frame: Up to completion of cycle 6
|
Will determine if the addition of CC-486 to R-miniCHOP results in excess toxicity compared to R-miniCHOP alone that would preclude the combination from being studied further.
|
Up to completion of cycle 6
|
Progression-free survival (PFS) (Phase II)
Time Frame: From date of registration to date of first observation of progressive disease according to the 2014 Lugano classification, or death due to any cause, assessed up to 1 year
|
Will determine if the CC-486 + R-miniCHOP regimen should be tested further (Phase III) against the control R-miniCHOP alone based on PFS.
After accruing 130 patients (65 per arm, 21 months of accrual and potentially pausing accrual for 6 months follow-up to reach a target 63 events across arms), a one-sided stratified .10
log-rank test will inform a go/no-go decision based on sufficient evidence of efficacy to continue to the Phase III portion of the study.
|
From date of registration to date of first observation of progressive disease according to the 2014 Lugano classification, or death due to any cause, assessed up to 1 year
|
Overall survival (Phase III)
Time Frame: From date of registration to date of death due to any cause, assessed up to 2 years
|
Will compare overall survival in the control arm of R-miniCHOP to the experimental arm of CC-486 (oral azacitidine) + R-miniCHOP.
Will be evaluated using a 1-sided .025
level stratified logrank test.
|
From date of registration to date of death due to any cause, assessed up to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Metabolic complete response (CR)
Time Frame: Up to end of cycle 6 or end of treatment
|
Will be defined using 2014 Lugano classification.
Fisher's exact test will be used to compare CR rates between the experimental arm of CC-486 + R-miniCHOP and the control arm of R-miniCHOP alone.
|
Up to end of cycle 6 or end of treatment
|
Incidence of adverse events
Time Frame: Until disease progression, assessed up to 5 years
|
Will be assessed using Common Terminology Criteria for Adverse Events version 5. The maximum Grade for each toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns.
Treatment-related toxicities between arms will be compared using Fisher's exact test.
|
Until disease progression, assessed up to 5 years
|
Overall survival (Phase III)
Time Frame: From date of registration to date of death due to any cause, assessed up to 5 years
|
An additional secondary analysis of overall survival of the Phase III comparison will adjust for patients with identified double-hit phenotype in addition to the pre-specified stratification factors.
Will also prospectively collect the number of days between diagnostic biopsy and cycle 1 day 1 of therapy for a pre-planned secondary analysis.
|
From date of registration to date of death due to any cause, assessed up to 5 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in function (Integrated Correlative Geriatric Assessments Substudy)
Time Frame: From time of randomization up to 24 months after date of registration
|
Will be assessed by a Comprehensive Geriatric Assessment (Carolina Frailty Index [CFI] Score) between patients treated with CC-486 + R-miniCHOP and those treated with R-miniCHOP alone.
Linear regression will be used for each examination, adjusting for the stratification factors from the clinical study and the baseline score (for the examination of change from 12 to 24 months, the 12-month score will be considered the baseline score).
Although the number of timepoints is limited to 3, longitudinal assessments of the CFI Score over time will also be conducted using linear mixed models, adjusting for the stratification factors and the baseline score, with patient considered a random effect.
|
From time of randomization up to 24 months after date of registration
|
Frailty status (fit/unfit vs frail) (Integrated Correlative Geriatric Assessments Substudy)
Time Frame: Baseline
|
Will evaluate if frailty status (fit/unfit versus frail) as assessed by the Italian Lymphoma Foundation (FIL) tool is associated with overall survival.
Multivariable Cox regression will be conducted, adjusting for the stratification variables and the randomized treatment arm as covariates.
Will also examine whether randomization to CC-486 + R-miniCHOP is associated with better overall survival compared to treatment with R-miniCHOP alone in the subset of fit and unfit patients.
Multivariable Cox regression will be conducted, adjusting for the stratification variables as covariates.
|
Baseline
|
Frailty status (Integrated Correlative Geriatric Assessments Substudy)
Time Frame: Up to 24 months after date of registration
|
Will evaluate if frailty status (fit/unfit versus frail) as assessed by the FIL tool correlates with the summary frailty indexed as measured by the S1918 Comprehensive Geriatric Assessment (CGA).
In particular, agreement between the FIL and CGA will measured using an unweighted Kappa statistic; moderate or better agreement is defined as a Kappa coefficient of >= 0.41.
|
Up to 24 months after date of registration
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Elizabeth A Brem, SWOG Cancer Research Network
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Neoplasms, Plasma Cell
- Lymphoma
- Lymphoma, Follicular
- Lymphoma, B-Cell
- Lymphoma, Large B-Cell, Diffuse
- Inflammation
- Waldenstrom Macroglobulinemia
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Cyclophosphamide
- Antibodies
- Immunoglobulins
- Rituximab
- Prednisone
- Azacitidine
- Doxorubicin
- Liposomal doxorubicin
- Antibodies, Monoclonal
- Antineoplastic Agents, Immunological
- Vincristine
- Cortisone
Other Study ID Numbers
- NCI-2020-01256 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- U10CA180888 (U.S. NIH Grant/Contract)
- S1918 (Other Identifier: CTEP)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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