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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

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

ArmDescriptionAssigned 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.
  • Drug: Cyclophosphamide
    Given IV
    Other names:
    • (-)-Cyclophosphamide
    • 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate
    • Asta B 518
    • B-518
    • Carloxan
    • Ciclofosfamida
    • Ciclofosfamide
    • Cicloxal
    • Clafen
    • Claphene
    • CP monohydrate
    • CTX
    • CYCLO-cell
    • Cycloblastin
    • Cycloblastine
    • Cyclophospham
    • Cyclophosphamid monohydrate
    • Cyclophosphamide Monohydrate
    • Cyclophosphamidum
    • Cyclophosphan
    • Cyclophosphane
    • Cyclophosphanum
    • Cyclostin
    • Cyclostine
    • Cytophosphan
    • Cytophosphane
    • Cytoxan
    • Fosfaseron
    • Genoxal
    • Genuxal
    • Ledoxina
    • Mitoxan
    • Neosar
    • Revimmune
    • Syklofosfamid
    • WR- 138719
    • WR-138719
  • Drug: Doxorubicin Hydrochloride
    Given IV
    Other names:
    • 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)
    • ADM
    • Adriacin
    • Adriamycin
    • Adriamycin Hydrochloride
    • Adriamycin PFS
    • Adriamycin RDF
    • ADRIAMYCIN, HYDROCHLORIDE
    • Adriamycine
    • Adriblastina
    • Adriblastine
    • Adrimedac
    • Chloridrato de Doxorrubicina
    • DOX
    • DOXO-CELL
    • Doxolem
    • Doxorubicin HCl
    • Doxorubicin.HCl
    • Doxorubin
    • Farmiblastina
    • FI 106
    • FI-106
    • hydroxydaunorubicin
    • Rubex
  • Drug: Oral Azacitidine
    Given PO
    Other names:
    • Azacitidine Oral
    • CC-486
    • Onureg
  • Drug: Prednisone
    Given PO
    Other names:
    • .delta.1-Cortisone
    • 1, 2-Dehydrocortisone
    • Adasone
    • Cortancyl
    • Dacortin
    • DeCortin
    • Decortisyl
    • Decorton
    • Delta 1-Cortisone
    • Delta-Dome
    • Deltacortene
    • Deltacortisone
    • Deltadehydrocortisone
    • Deltasone
    • Deltison
    • Deltra
    • Econosone
    • Lisacort
    • Meprosona-F
    • Metacortandracin
    • Meticorten
    • Ofisolona
    • Orasone
    • Panafcort
    • Panasol-S
    • Paracort
    • Perrigo Prednisone
    • PRED
    • Predicor
    • Predicorten
    • Prednicen-M
    • Prednicort
    • Prednidib
    • Prednilonga
    • Predniment
    • Prednisone Intensol
    • Prednisonum
    • Prednitone
    • Promifen
    • Rayos
    • Servisone
    • SK-Prednisone
  • Other: Questionnaire Administration
    Ancillary studies
  • Biological: Rituximab
    Given IV or SC
    Other names:
    • ABP 798
    • BI 695500
    • C2B8 Monoclonal Antibody
    • Chimeric Anti-CD20 Antibody
    • CT-P10
    • IDEC-102
    • IDEC-C2B8
    • IDEC-C2B8 Monoclonal Antibody
    • Ikgdar
    • Mabtas
    • MabThera
    • Monoclonal Antibody IDEC-C2B8
    • PF-05280586
    • Riabni
    • Rituxan
    • Rituximab ABBS
    • Rituximab ARRX
    • Rituximab Biosimilar ABP 798
    • Rituximab Biosimilar BI 695500
    • Rituximab Biosimilar CT-P10
    • Rituximab Biosimilar GB241
    • Rituximab Biosimilar IBI301
    • Rituximab Biosimilar JHL1101
    • Rituximab Biosimilar PF-05280586
    • Rituximab Biosimilar RTXM83
    • Rituximab Biosimilar SAIT101
    • Rituximab Biosimilar SIBP-02
    • rituximab biosimilar TQB2303
    • Rituximab PVVR
    • Rituximab-abbs
    • Rituximab-arrx
    • Rituximab-pvvr
    • RTXM83
    • Ruxience
    • Truxima
  • Drug: Vincristine Sulfate
    Given IV
    Other names:
    • Kyocristine
    • Leurocristine Sulfate
    • Leurocristine, sulfate
    • Oncovin
    • Vincasar
    • Vincosid
    • Vincrex
    • Vincristine, sulfate
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.
  • Drug: Cyclophosphamide
    Given IV
    Other names:
    • (-)-Cyclophosphamide
    • 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate
    • Asta B 518
    • B-518
    • Carloxan
    • Ciclofosfamida
    • Ciclofosfamide
    • Cicloxal
    • Clafen
    • Claphene
    • CP monohydrate
    • CTX
    • CYCLO-cell
    • Cycloblastin
    • Cycloblastine
    • Cyclophospham
    • Cyclophosphamid monohydrate
    • Cyclophosphamide Monohydrate
    • Cyclophosphamidum
    • Cyclophosphan
    • Cyclophosphane
    • Cyclophosphanum
    • Cyclostin
    • Cyclostine
    • Cytophosphan
    • Cytophosphane
    • Cytoxan
    • Fosfaseron
    • Genoxal
    • Genuxal
    • Ledoxina
    • Mitoxan
    • Neosar
    • Revimmune
    • Syklofosfamid
    • WR- 138719
    • WR-138719
  • Drug: Doxorubicin Hydrochloride
    Given IV
    Other names:
    • 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)
    • ADM
    • Adriacin
    • Adriamycin
    • Adriamycin Hydrochloride
    • Adriamycin PFS
    • Adriamycin RDF
    • ADRIAMYCIN, HYDROCHLORIDE
    • Adriamycine
    • Adriblastina
    • Adriblastine
    • Adrimedac
    • Chloridrato de Doxorrubicina
    • DOX
    • DOXO-CELL
    • Doxolem
    • Doxorubicin HCl
    • Doxorubicin.HCl
    • Doxorubin
    • Farmiblastina
    • FI 106
    • FI-106
    • hydroxydaunorubicin
    • Rubex
  • Drug: Prednisone
    Given PO
    Other names:
    • .delta.1-Cortisone
    • 1, 2-Dehydrocortisone
    • Adasone
    • Cortancyl
    • Dacortin
    • DeCortin
    • Decortisyl
    • Decorton
    • Delta 1-Cortisone
    • Delta-Dome
    • Deltacortene
    • Deltacortisone
    • Deltadehydrocortisone
    • Deltasone
    • Deltison
    • Deltra
    • Econosone
    • Lisacort
    • Meprosona-F
    • Metacortandracin
    • Meticorten
    • Ofisolona
    • Orasone
    • Panafcort
    • Panasol-S
    • Paracort
    • Perrigo Prednisone
    • PRED
    • Predicor
    • Predicorten
    • Prednicen-M
    • Prednicort
    • Prednidib
    • Prednilonga
    • Predniment
    • Prednisone Intensol
    • Prednisonum
    • Prednitone
    • Promifen
    • Rayos
    • Servisone
    • SK-Prednisone
  • Other: Questionnaire Administration
    Ancillary studies
  • Biological: Rituximab
    Given IV or SC
    Other names:
    • ABP 798
    • BI 695500
    • C2B8 Monoclonal Antibody
    • Chimeric Anti-CD20 Antibody
    • CT-P10
    • IDEC-102
    • IDEC-C2B8
    • IDEC-C2B8 Monoclonal Antibody
    • Ikgdar
    • Mabtas
    • MabThera
    • Monoclonal Antibody IDEC-C2B8
    • PF-05280586
    • Riabni
    • Rituxan
    • Rituximab ABBS
    • Rituximab ARRX
    • Rituximab Biosimilar ABP 798
    • Rituximab Biosimilar BI 695500
    • Rituximab Biosimilar CT-P10
    • Rituximab Biosimilar GB241
    • Rituximab Biosimilar IBI301
    • Rituximab Biosimilar JHL1101
    • Rituximab Biosimilar PF-05280586
    • Rituximab Biosimilar RTXM83
    • Rituximab Biosimilar SAIT101
    • Rituximab Biosimilar SIBP-02
    • rituximab biosimilar TQB2303
    • Rituximab PVVR
    • Rituximab-abbs
    • Rituximab-arrx
    • Rituximab-pvvr
    • RTXM83
    • Ruxience
    • Truxima
  • Drug: Vincristine Sulfate
    Given IV
    Other names:
    • Kyocristine
    • Leurocristine Sulfate
    • Leurocristine, sulfate
    • Oncovin
    • Vincasar
    • Vincosid
    • Vincrex
    • Vincristine, sulfate

Recruiting Locations

University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
Contact:
Site Public Contact
501-686-8274

Kaiser Permanente-Anaheim
Anaheim, California 92806
Contact:
Site Public Contact
800-398-3996
clinical.trials@kp.org

Kaiser Permanente-Baldwin Park
Baldwin Park, California 91706
Contact:
Site Public Contact
800-398-3996
clinical.trials@kp.org

Kaiser Permanente-Bellflower
Bellflower, California 90706
Contact:
Site Public Contact
800-398-3996
clinical.trials@kp.org

Tower Cancer Research Foundation
Beverly Hills, California 90211
Contact:
Site Public Contact
towercancerresearch@toweroncology.com

City of Hope Comprehensive Cancer Center
Duarte, California 91010
Contact:
Site Public Contact
800-826-4673
becomingapatient@coh.org

Kaiser Permanente-Fontana
Fontana, California 92335
Contact:
Site Public Contact
800-398-3996
clinical.trials@kp.org

Kaiser Permanente - Harbor City
Harbor City, California 90710
Contact:
Site Public Contact
800-398-3996
clinical.trials@kp.org

City of Hope at Huntington Beach
Huntington Beach, California 92648
Contact:
Site Public Contact
877-467-3411

City of Hope at Irvine Lennar
Irvine, California 92618
Contact:
Site Public Contact
877-467-3411

Kaiser Permanente-Irvine
Irvine, California 92618
Contact:
Site Public Contact
800-398-3996
clinical.trials@kp.org

City of Hope Antelope Valley
Lancaster, California 93534
Contact:
Site Public Contact
800-826-4673
becomingapatient@coh.org

City of Hope at Long Beach Elm
Long Beach, California 90813
Contact:
Site Public Contact
877-467-3411

Tibor Rubin VA Medical Center
Long Beach, California 90822
Contact:
Site Public Contact
562-826-8000

Kaiser Permanente Los Angeles Medical Center
Los Angeles, California 90027
Contact:
Site Public Contact
800-398-3996
clinical.trials@kp.org

Kaiser Permanente West Los Angeles
Los Angeles, California 90034
Contact:
Site Public Contact
800-398-3996
clinical.trials@kp.org

Cedars Sinai Medical Center
Los Angeles, California 90048
Contact:
Site Public Contact
310-423-8965

City of Hope Newport Beach
Newport Beach, California 92660
Contact:
Site Public Contact
877-467-3411

Kaiser Permanente-Ontario
Ontario, California 91761
Contact:
Site Public Contact
800-398-3996
clinical.trials@kp.org

UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California 92868
Contact:
Site Public Contact
877-827-8839
ucstudy@uci.edu

Stanford Cancer Institute Palo Alto
Palo Alto, California 94304
Contact:
Site Public Contact
650-498-7061
ccto-office@stanford.edu

Kaiser Permanente - Panorama City
Panorama City, California 91402
Contact:
Site Public Contact
800-398-3996
clinical.trials@kp.org

Kaiser Permanente-Riverside
Riverside, California 92505
Contact:
Site Public Contact
800-398-3996
clinical.trials@kp.org

Kaiser Permanente-San Diego Zion
San Diego, California 92120
Contact:
Site Public Contact
800-398-3996
clinical.trials@kp.org

Kaiser Permanente-San Marcos
San Marcos, California 92078
Contact:
Site Public Contact
800-398-3996
clinical.trials@kp.org

UCSF Cancer Center - San Mateo
San Mateo, California 94402
Contact:
Site Public Contact
877-827-3222
cancertrials@ucsf.edu

City of Hope South Pasadena
South Pasadena, California 91030
Contact:
Site Public Contact
800-826-4673
becomingapatient@coh.org

City of Hope South Bay
Torrance, California 90503
Contact:
Site Public Contact
877-467-3411

City of Hope Upland
Upland, California 91786
Contact:
Site Public Contact
800-826-4673
becomingapatient@coh.org

Kaiser Permanente-Woodland Hills
Woodland Hills, California 91367
Contact:
Site Public Contact
800-398-3996
clinical.trials@kp.org

SCL Health Cancer Centers of Colorado - Lutheran Medical Center
Golden, Colorado 80401
Contact:
Site Public Contact
303-813-5225
Alan.miller@sclhealth.org

Helen F Graham Cancer Center
Newark, Delaware 19713
Contact:
Site Public Contact
302-623-4450
lbarone@christianacare.org

Medical Oncology Hematology Consultants PA
Newark, Delaware 19713
Contact:
Site Public Contact
302-623-4450
lbarone@christianacare.org

Emory University Hospital Midtown
Atlanta, Georgia 30308
Contact:
Site Public Contact
888-946-7447

Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia 30322
Contact:
Site Public Contact
404-778-1868

Emory Saint Joseph's Hospital
Atlanta, Georgia 30342
Contact:
Site Public Contact
404-851-7115

Augusta University Medical Center
Augusta, Georgia 30912
Contact:
Site Public Contact
706-721-2388
ga_cares@augusta.edu

Hawaii Cancer Care - Westridge
'Aiea, Hawaii 96701
Contact:
Site Public Contact
808-539-2273
info@hawaiicancercare.com

Pali Momi Medical Center
'Aiea, Hawaii 96701
Contact:
Site Public Contact
808-486-6000

Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii 96813
Contact:
Site Public Contact
808-524-6115
i.webster@hawaiicancercare.com

Queen's Cancer Cenrer - POB I
Honolulu, Hawaii 96813
Contact:
Site Public Contact
808-532-0315

Queen's Medical Center
Honolulu, Hawaii 96813
Contact:
Site Public Contact
808-545-8548

Straub Clinic and Hospital
Honolulu, Hawaii 96813
Contact:
Site Public Contact
808-522-4333

Queen's Cancer Center - Kuakini
Honolulu, Hawaii 96817
Contact:
Site Public Contact
808-531-8521

Northwestern University
Chicago, Illinois 60611
Contact:
Site Public Contact
312-695-1301
cancer@northwestern.edu

University of Illinois
Chicago, Illinois 60612
Contact:
Site Public Contact
312-355-3046

University of Chicago Comprehensive Cancer Center
Chicago, Illinois 60637
Contact:
Site Public Contact
773-702-8222
cancerclinicaltrials@bsd.uchicago.edu

Carle at The Riverfront
Danville, Illinois 61832
Contact:
Site Public Contact
800-446-5532
Research@Carle.com

Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois 62526
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Decatur Memorial Hospital
Decatur, Illinois 62526
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois 60115
Contact:
Site Public Contact
630-352-5360
Donald.Smith3@nm.org

Crossroads Cancer Center
Effingham, Illinois 62401
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois 60201
Contact:
Site Public Contact
847-570-2109

Northwestern Medicine Cancer Center Delnor
Geneva, Illinois 60134
Contact:
Site Public Contact
630-352-5360
Donald.Smith3@nm.org

NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois 60026
Contact:
Site Public Contact
847-570-2109

NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois 60035
Contact:
Site Public Contact
847-570-2109

Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois 60045
Contact:
Site Public Contact
cancertrials@northwestern.edu

UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois 60451
Contact:
Site Public Contact
773-702-8222
cancerclinicaltrials@bsd.uchicago.edu

Cancer Care Center of O'Fallon
O'Fallon, Illinois 62269
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

University of Chicago Medicine-Orland Park
Orland Park, Illinois 60462
Contact:
Site Public Contact
773-702-8222
cancerclinicaltrials@bsd.uchicago.edu

Illinois CancerCare-Peoria
Peoria, Illinois 61615
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Memorial Hospital East
Shiloh, Illinois 62269
Contact:
Site Public Contact
314-747-9912
dschwab@wustl.edu

Carle Cancer Center
Urbana, Illinois 61801
Contact:
Site Public Contact
800-446-5532
Research@carle.com

Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois 60555
Contact:
Site Public Contact
630-352-5360
Donald.Smith3@nm.org

McFarland Clinic - Ames
Ames, Iowa 50010
Contact:
Site Public Contact
515-239-4734
ksoder@mcfarlandclinic.com

Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa 50309
Contact:
Site Public Contact
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Ochsner LSU Health Monroe Medical Center
Monroe, Louisiana 71202
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Tufts Medical Center
Boston, Massachusetts 02111
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Saint Joseph Mercy Hospital
Ann Arbor, Michigan 48106
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Brighton, Michigan 48114
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Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan 48114
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Canton, Michigan 48188
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Chelsea, Michigan 48118
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Livonia, Michigan 48154
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Ypsilanti, Michigan 48106
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Ypsilanti, Michigan 48197
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Essentia Health - Deer River Clinic
Deer River, Minnesota 56636
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Essentia Health Cancer Center
Duluth, Minnesota 55805
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Hibbing, Minnesota 55746
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Sandstone, Minnesota 55072
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Virginia, Minnesota 55792
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Oxford, Mississippi 38655
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Cape Girardeau, Missouri 63703
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Creve Coeur, Missouri 63141
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Saint Louis, Missouri 63110
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Saint Louis, Missouri 63129
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Lincoln, Nebraska 68516
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UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina 27599
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Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio 44111
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Cleveland Clinic Foundation
Cleveland, Ohio 44195
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Columbus, Ohio 43210
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Independence, Ohio 44131
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Mansfield, Ohio 44906
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Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio 44124
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Sandusky, Ohio 44870
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Wooster, Ohio 44691
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Cancer Centers of Southwest Oklahoma Research
Lawton, Oklahoma 73505
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University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
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Providence Saint Vincent Medical Center
Portland, Oregon 97225
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Portland VA Medical Center
Portland, Oregon 97239
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Medical University of South Carolina
Charleston, South Carolina 29425
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Saint Francis Hospital
Greenville, South Carolina 29601
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Saint Francis Cancer Center
Greenville, South Carolina 29607
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Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee 38120
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Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah 84112
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University of Virginia Cancer Center
Charlottesville, Virginia 22908
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Inova Schar Cancer Institute
Fairfax, Virginia 22031
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FHCC Overlake
Bellevue, Washington 98004
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Seattle Cancer Care Alliance at EvergreenHealth
Kirkland, Washington 98034
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Seattle, Washington 98133
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West Virginia University Charleston Division
Charleston, West Virginia 25304
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Duluth Clinic Ashland
Ashland, Wisconsin 54806
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Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin 54701
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Gundersen Lutheran Medical Center
La Crosse, Wisconsin 54601
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608-775-2385
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Marshfield Medical Center-Marshfield
Marshfield, Wisconsin 54449
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Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin 54548
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Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin 54868
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Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin 54482
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Marshfield Medical Center - Weston
Weston, Wisconsin 54476
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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.

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