Testing CC-486 (Oral Azacitidine) Plus the Standard Drug Therapy in Patients 75 Years or Older With Newly Diagnosed Diffuse Large B Cell Lymphoma
Purpose
This phase II/III trial compares the side effects and activity of oral azacitidine in combination with the standard drug therapy (reduced dose rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone [R-miniCHOP]) versus R-miniCHOP alone in treating patients 75 years or older with newly diagnosed diffuse large B cell lymphoma. R-miniCHOP includes a monoclonal antibody (a type of protein), called rituximab, which attaches to the lymphoma cells and may help the immune system kill these cells. R-miniCHOP also includes prednisone which is an anti-inflammatory medication and a combination of 3 chemotherapy drugs, cyclophosphamide, doxorubicin, and vincristine. These 3 chemotherapy drugs, as well as oral azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Combining oral azacitidine with R-miniCHOP may shrink the cancer or extend the time without disease symptoms coming back or extend patient's survival when compared to R-miniCHOP alone.
Conditions
- Ann Arbor Stage III Diffuse Large B-Cell Lymphoma
- Ann Arbor Stage IIX (Bulky) Diffuse Large B-Cell Lymphoma
- Ann Arbor Stage IV Diffuse Large B-Cell Lymphoma
- Diffuse Large B-Cell Lymphoma Activated B-Cell Type
- Diffuse Large B-Cell Lymphoma Associated With Chronic Inflammation
- Diffuse Large B-Cell Lymphoma Germinal Center B-Cell Type
- Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
- EBV-Positive Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
- Grade 3b Follicular Lymphoma
- HHV8-Positive Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
- High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements
- High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
- High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements
- High Grade B-Cell Lymphoma, Not Otherwise Specified
- Intravascular Large B-Cell Lymphoma
- Lymphoplasmacytic Lymphoma
- Nodular Lymphocyte Predominant Hodgkin Lymphoma
- Primary Cutaneous Diffuse Large B-Cell Lymphoma, Leg Type
- T-Cell/Histiocyte-Rich Large B-Cell Lymphoma
- Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma
- Transformed Marginal Zone Lymphoma to Diffuse Large B-Cell Lymphoma
Eligibility
- Eligible Ages
- Over 75 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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 Design
- Phase
- Phase 2/Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
|
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. |
|
Recruiting Locations
University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
Contact:
Site Public Contact
501-686-8274
Site Public Contact
501-686-8274
Kaiser Permanente-Anaheim
Anaheim, California 92806
Anaheim, California 92806
Kaiser Permanente-Baldwin Park
Baldwin Park, California 91706
Baldwin Park, California 91706
Kaiser Permanente-Bellflower
Bellflower, California 90706
Bellflower, California 90706
Tower Cancer Research Foundation
Beverly Hills, California 90211
Beverly Hills, California 90211
UC Irvine Health Cancer Center-Newport
Costa Mesa, California 92627
Costa Mesa, California 92627
Contact:
Site Public Contact
877-827-8839
Site Public Contact
877-827-8839
City of Hope Comprehensive Cancer Center
Duarte, California 91010
Duarte, California 91010
Kaiser Permanente-Fontana
Fontana, California 92335
Fontana, California 92335
Kaiser Permanente - Harbor City
Harbor City, California 90710
Harbor City, California 90710
Kaiser Permanente-Irvine
Irvine, California 92618
Irvine, California 92618
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California 90027
Los Angeles, California 90027
Kaiser Permanente West Los Angeles
Los Angeles, California 90034
Los Angeles, California 90034
Cedars Sinai Medical Center
Los Angeles, California 90048
Los Angeles, California 90048
Contact:
Site Public Contact
310-423-8965
Site Public Contact
310-423-8965
Kaiser Permanente-Ontario
Ontario, California 91761
Ontario, California 91761
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California 92868
Orange, California 92868
Stanford Cancer Institute Palo Alto
Palo Alto, California 94304
Palo Alto, California 94304
Kaiser Permanente - Panorama City
Panorama City, California 91402
Panorama City, California 91402
Kaiser Permanente-Riverside
Riverside, California 92505
Riverside, California 92505
Kaiser Permanente-San Diego Zion
San Diego, California 92120
San Diego, California 92120
Kaiser Permanente-San Marcos
San Marcos, California 92078
San Marcos, California 92078
UCSF Cancer Center - San Mateo
San Mateo, California 94402
San Mateo, California 94402
Kaiser Permanente-Woodland Hills
Woodland Hills, California 91367
Woodland Hills, California 91367
Delaware Clinical and Laboratory Physicians PA
Newark, Delaware 19713
Newark, Delaware 19713
Helen F Graham Cancer Center
Newark, Delaware 19713
Newark, Delaware 19713
Medical Oncology Hematology Consultants PA
Newark, Delaware 19713
Newark, Delaware 19713
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida 33136
Miami, Florida 33136
Contact:
Site Public Contact
305-243-2647
Site Public Contact
305-243-2647
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia 30322
Atlanta, Georgia 30322
Contact:
Site Public Contact
404-778-1868
Site Public Contact
404-778-1868
Emory Saint Joseph's Hospital
Atlanta, Georgia 30342
Atlanta, Georgia 30342
Contact:
Site Public Contact
404-851-7115
Site Public Contact
404-851-7115
Augusta University Medical Center
Augusta, Georgia 30912
Augusta, Georgia 30912
Hawaii Cancer Care - Westridge
'Aiea, Hawaii 96701
'Aiea, Hawaii 96701
Pali Momi Medical Center
'Aiea, Hawaii 96701
'Aiea, Hawaii 96701
Contact:
Site Public Contact
808-486-6000
Site Public Contact
808-486-6000
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii 96813
Honolulu, Hawaii 96813
Queen's Cancer Cenrer - POB I
Honolulu, Hawaii 96813
Honolulu, Hawaii 96813
Contact:
Site Public Contact
808-532-0315
Site Public Contact
808-532-0315
Queen's Medical Center
Honolulu, Hawaii 96813
Honolulu, Hawaii 96813
Contact:
Site Public Contact
808-545-8548
Site Public Contact
808-545-8548
Straub Clinic and Hospital
Honolulu, Hawaii 96813
Honolulu, Hawaii 96813
Contact:
Site Public Contact
808-522-4333
Site Public Contact
808-522-4333
Queen's Cancer Center - Kuakini
Honolulu, Hawaii 96817
Honolulu, Hawaii 96817
Contact:
Site Public Contact
808-531-8521
Site Public Contact
808-531-8521
Northwestern University
Chicago, Illinois 60611
Chicago, Illinois 60611
University of Chicago Comprehensive Cancer Center
Chicago, Illinois 60637
Chicago, Illinois 60637
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois 60115
DeKalb, Illinois 60115
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois 60201
Evanston, Illinois 60201
Contact:
Site Public Contact
847-570-2109
Site Public Contact
847-570-2109
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois 60134
Geneva, Illinois 60134
NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois 60026
Glenview, Illinois 60026
Contact:
Site Public Contact
847-570-2109
Site Public Contact
847-570-2109
NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois 60035
Highland Park, Illinois 60035
Contact:
Site Public Contact
847-570-2109
Site Public Contact
847-570-2109
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois 60045
Lake Forest, Illinois 60045
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois 60451
New Lenox, Illinois 60451
University of Chicago Medicine-Orland Park
Orland Park, Illinois 60462
Orland Park, Illinois 60462
Carle Cancer Center
Urbana, Illinois 61801
Urbana, Illinois 61801
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois 60555
Warrenville, Illinois 60555
McFarland Clinic PC - Ames
Ames, Iowa 50010
Ames, Iowa 50010
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa 50309
Des Moines, Iowa 50309
Contact:
Site Public Contact
515-241-3305
Site Public Contact
515-241-3305
LSU Health Sciences Center at Shreveport
Shreveport, Louisiana 71103
Shreveport, Louisiana 71103
Tufts Medical Center
Boston, Massachusetts 02111
Boston, Massachusetts 02111
Saint Joseph Mercy Hospital
Ann Arbor, Michigan 48106
Ann Arbor, Michigan 48106
Saint Joseph Mercy Brighton
Brighton, Michigan 48114
Brighton, Michigan 48114
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan 48114
Brighton, Michigan 48114
Saint Joseph Mercy Canton
Canton, Michigan 48188
Canton, Michigan 48188
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan 48188
Canton, Michigan 48188
Saint Joseph Mercy Chelsea
Chelsea, Michigan 48118
Chelsea, Michigan 48118
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan 48118
Chelsea, Michigan 48118
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan 48154
Livonia, Michigan 48154
Huron Gastroenterology PC
Ypsilanti, Michigan 48106
Ypsilanti, Michigan 48106
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan 48197
Ypsilanti, Michigan 48197
Essentia Health - Deer River Clinic
Deer River, Minnesota 56636
Deer River, Minnesota 56636
Essentia Health Cancer Center
Duluth, Minnesota 55805
Duluth, Minnesota 55805
Essentia Health Hibbing Clinic
Hibbing, Minnesota 55746
Hibbing, Minnesota 55746
Contact:
Site Public Contact
218-786-3308
Site Public Contact
218-786-3308
Essentia Health Sandstone
Sandstone, Minnesota 55072
Sandstone, Minnesota 55072
Essentia Health Virginia Clinic
Virginia, Minnesota 55792
Virginia, Minnesota 55792
Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven, Mississippi 38671
Southhaven, Mississippi 38671
Saint Luke's Hospital
Chesterfield, Missouri 63017
Chesterfield, Missouri 63017
Contact:
Site Public Contact
314-205-6936
Site Public Contact
314-205-6936
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri 63141
Creve Coeur, Missouri 63141
Washington University School of Medicine
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
Siteman Cancer Center-South County
Saint Louis, Missouri 63129
Saint Louis, Missouri 63129
Siteman Cancer Center at Christian Hospital
Saint Louis, Missouri 63136
Saint Louis, Missouri 63136
Siteman Cancer Center at Saint Peters Hospital
Saint Peters, Missouri 63376
Saint Peters, Missouri 63376
Cancer Partners of Nebraska - Pine Lake
Lincoln, Nebraska 68516
Lincoln, Nebraska 68516
Southeast Nebraska Cancer Center - 68th Street Place
Lincoln, Nebraska 68516
Lincoln, Nebraska 68516
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey 07920
Basking Ridge, New Jersey 07920
Contact:
Site Public Contact
212-639-7592
Site Public Contact
212-639-7592
Memorial Sloan Kettering Monmouth
Middletown, New Jersey 07748
Middletown, New Jersey 07748
Contact:
Site Public Contact
212-639-7592
Site Public Contact
212-639-7592
Memorial Sloan Kettering Bergen
Montvale, New Jersey 07645
Montvale, New Jersey 07645
Contact:
Site Public Contact
212-639-7592
Site Public Contact
212-639-7592
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08903
New Brunswick, New Jersey 08903
Contact:
Site Public Contact
732-235-7356
Site Public Contact
732-235-7356
Roswell Park Cancer Institute
Buffalo, New York 14263
Buffalo, New York 14263
Memorial Sloan Kettering Commack
Commack, New York 11725
Commack, New York 11725
Contact:
Site Public Contact
212-639-7592
Site Public Contact
212-639-7592
Memorial Sloan Kettering Westchester
Harrison, New York 10604
Harrison, New York 10604
Contact:
Site Public Contact
212-639-7592
Site Public Contact
212-639-7592
NYU Winthrop Hospital
Mineola, New York 11501
Mineola, New York 11501
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York 10016
New York, New York 10016
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York 10032
New York, New York 10032
Memorial Sloan Kettering Cancer Center
New York, New York 10065
New York, New York 10065
Contact:
Site Public Contact
212-639-7592
Site Public Contact
212-639-7592
NYP/Weill Cornell Medical Center
New York, New York 10065
New York, New York 10065
Contact:
Site Public Contact
212-746-1848
Site Public Contact
212-746-1848
Upstate Cancer Center at Oneida
Oneida, New York 13421
Oneida, New York 13421
Upstate Cancer Center at Oswego
Oswego, New York 13126
Oswego, New York 13126
State University of New York Upstate Medical University
Syracuse, New York 13210
Syracuse, New York 13210
Contact:
Site Public Contact
315-464-5476
Site Public Contact
315-464-5476
Memorial Sloan Kettering Nassau
Uniondale, New York 11553
Uniondale, New York 11553
Contact:
Site Public Contact
212-639-7592
Site Public Contact
212-639-7592
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio 44111
Cleveland, Ohio 44111
Cleveland Clinic Foundation
Cleveland, Ohio 44195
Cleveland, Ohio 44195
Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
Columbus, Ohio 43210
Cleveland Clinic Cancer Center Independence
Independence, Ohio 44131
Independence, Ohio 44131
Cleveland Clinic Cancer Center Mansfield
Mansfield, Ohio 44906
Mansfield, Ohio 44906
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio 44124
Mayfield Heights, Ohio 44124
North Coast Cancer Care
Sandusky, Ohio 44870
Sandusky, Ohio 44870
Cleveland Clinic Cancer Center Strongsville
Strongsville, Ohio 44136
Strongsville, Ohio 44136
South Pointe Hospital
Warrensville Heights, Ohio 44122
Warrensville Heights, Ohio 44122
Cleveland Clinic Wooster Family Health and Surgery Center
Wooster, Ohio 44691
Wooster, Ohio 44691
Cancer Centers of Southwest Oklahoma Research
Lawton, Oklahoma 73505
Lawton, Oklahoma 73505
Contact:
Site Public Contact
877-231-4440
Site Public Contact
877-231-4440
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
Oklahoma City, Oklahoma 73104
Portland VA Medical Center
Portland, Oregon 97239
Portland, Oregon 97239
Contact:
Site Public Contact
800-949-1004
Site Public Contact
800-949-1004
Medical University of South Carolina
Charleston, South Carolina 29425
Charleston, South Carolina 29425
Saint Francis Cancer Center
Greenville, South Carolina 29607
Greenville, South Carolina 29607
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee 38120
Memphis, Tennessee 38120
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah 84112
Salt Lake City, Utah 84112
University of Virginia Cancer Center
Charlottesville, Virginia 22908
Charlottesville, Virginia 22908
Inova Schar Cancer Institute
Fairfax, Virginia 22031
Fairfax, Virginia 22031
FHCC Overlake
Bellevue, Washington 98004
Bellevue, Washington 98004
Contact:
Site Public Contact
425-454-2148
Site Public Contact
425-454-2148
Seattle Cancer Care Alliance at EvergreenHealth
Kirkland, Washington 98034
Kirkland, Washington 98034
Contact:
Site Public Contact
425-899-6000
Site Public Contact
425-899-6000
FHCC at Northwest Hospital
Seattle, Washington 98133
Seattle, Washington 98133
Contact:
Site Public Contact
206-606-5800
Site Public Contact
206-606-5800
West Virginia University Charleston Division
Charleston, West Virginia 25304
Charleston, West Virginia 25304
Contact:
Site Public Contact
304-388-9944
Site Public Contact
304-388-9944
Duluth Clinic Ashland
Ashland, Wisconsin 54806
Ashland, Wisconsin 54806
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin 54701
Eau Claire, Wisconsin 54701
Gundersen Lutheran Medical Center
La Crosse, Wisconsin 54601
La Crosse, Wisconsin 54601
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin 54449
Marshfield, Wisconsin 54449
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin 54548
Minocqua, Wisconsin 54548
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin 54868
Rice Lake, Wisconsin 54868
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin 54482
Stevens Point, Wisconsin 54482
Marshfield Medical Center - Weston
Weston, Wisconsin 54476
Weston, Wisconsin 54476
More Details
- NCT ID
- NCT04799275
- Status
- Recruiting
- Sponsor
- National Cancer Institute (NCI)
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.