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Test CC-486 (azacitidina orale) più la terapia farmacologica standard in pazienti di età pari o superiore a 75 anni con linfoma diffuso a grandi cellule B di nuova diagnosi

24 ottobre 2026 aggiornato da: National Cancer Institute (NCI)

Uno studio randomizzato di fase II/III su R-MiniCHOP con o senza CC-486 (azacitidina orale) in partecipanti di età pari o superiore a 75 anni con linfoma diffuso a grandi cellule B di nuova diagnosi, linfoma follicolare di grado IIIB, linfoma trasformato e grado B alto -Linfomi cellulari con riarrangiamenti di MYC E BCL2 e/o BCL6

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.

Panoramica dello studio

Stato

Attivo, non reclutante

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 rituximab and hyaluronidase human 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. Patients undergo echocardiography (ECHO) or multigated acquisition scan (MUGA) at screening and undergo positron emission tomography (PET)-computed tomography (CT) and blood sample collection throughout the study.

ARM II: Patients receive rituximab IV (or rituximab and hyaluronidase human 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. Patients undergo ECHO or MUGA at screening and undergo PET-CT and blood sample collection throughout the study.

After completion of study treatment, patients are followed up periodically until 5 years from the date of registration.

Tipo di studio

Interventistico

Iscrizione (Stimato)

422

Fase

  • Fase 2
  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Arizona
      • Tucson, Arizona, Stati Uniti, 85719
        • Banner University Medical Center - Tucson
      • Tucson, Arizona, Stati Uniti, 85719
        • University of Arizona Cancer Center-North Campus
    • Arkansas
      • Little Rock, Arkansas, Stati Uniti, 72205
        • University of Arkansas for Medical Sciences
    • California
      • Anaheim, California, Stati Uniti, 92806
        • Kaiser Permanente-Anaheim
      • Baldwin Park, California, Stati Uniti, 91706
        • Kaiser Permanente-Baldwin Park
      • Bellflower, California, Stati Uniti, 90706
        • Kaiser Permanente-Bellflower
      • Beverly Hills, California, Stati Uniti, 90211
        • Tower Cancer Research Foundation
      • Costa Mesa, California, Stati Uniti, 92627
        • UC Irvine Health Cancer Center-Newport
      • Duarte, California, Stati Uniti, 91010
        • City of Hope Comprehensive Cancer Center
      • Fontana, California, Stati Uniti, 92335
        • Kaiser Permanente-Fontana
      • Harbor City, California, Stati Uniti, 90710
        • Kaiser Permanente South Bay
      • Huntington Beach, California, Stati Uniti, 92648
        • City of Hope Seacliff
      • Irvine, California, Stati Uniti, 92618
        • Kaiser Permanente-Irvine
      • Irvine, California, Stati Uniti, 92618
        • City of Hope at Irvine Lennar
      • Lancaster, California, Stati Uniti, 93534
        • City of Hope Antelope Valley
      • Long Beach, California, Stati Uniti, 90822
        • Tibor Rubin VA Medical Center
      • Long Beach, California, Stati Uniti, 90813
        • City of Hope at Long Beach Elm
      • Los Angeles, California, Stati Uniti, 90048
        • Cedars-Sinai Medical Center
      • Los Angeles, California, Stati Uniti, 90027
        • Kaiser Permanente Los Angeles Medical Center
      • Los Angeles, California, Stati Uniti, 90034
        • Kaiser Permanente West Los Angeles
      • Newport Beach, California, Stati Uniti, 92660
        • City of Hope Newport Beach
      • Ontario, California, Stati Uniti, 91761
        • Kaiser Permanente-Ontario
      • Orange, California, Stati Uniti, 92868
        • UC Irvine Health/Chao Family Comprehensive Cancer Center
      • Palo Alto, California, Stati Uniti, 94304
        • Stanford Cancer Institute Palo Alto
      • Panorama City, California, Stati Uniti, 91402
        • Kaiser Permanente - Panorama City
      • Riverside, California, Stati Uniti, 92505
        • Kaiser Permanente-Riverside
      • San Diego, California, Stati Uniti, 92120
        • Kaiser Permanente-San Diego Zion
      • San Marcos, California, Stati Uniti, 92078
        • Kaiser Permanente-San Marcos
      • San Mateo, California, Stati Uniti, 94402
        • UCSF Cancer Center - San Mateo
      • South Pasadena, California, Stati Uniti, 91030
        • City of Hope South Pasadena
      • Torrance, California, Stati Uniti, 90503
        • City of Hope South Bay
      • Upland, California, Stati Uniti, 91786
        • City of Hope Upland
      • Woodland Hills, California, Stati Uniti, 91367
        • Kaiser Permanente-Woodland Hills
    • Colorado
      • Golden, Colorado, Stati Uniti, 80401
        • Lutheran Hospital - Cancer Centers of Colorado
    • Delaware
      • Newark, Delaware, Stati Uniti, 19713
        • Helen F Graham Cancer Center
      • Newark, Delaware, Stati Uniti, 19713
        • Delaware Clinical and Laboratory Physicians PA
      • Newark, Delaware, Stati Uniti, 19713
        • Medical Oncology Hematology Consultants PA
    • Florida
      • Miami, Florida, Stati Uniti, 33136
        • University of Miami Miller School of Medicine-Sylvester Cancer Center
    • Georgia
      • Atlanta, Georgia, Stati Uniti, 30308
        • Emory University Hospital Midtown
      • Atlanta, Georgia, Stati Uniti, 30322
        • Emory University Hospital/Winship Cancer Institute
      • Atlanta, Georgia, Stati Uniti, 30342
        • Emory Saint Joseph's Hospital
      • Augusta, Georgia, Stati Uniti, 30912
        • Augusta University Medical Center
    • Hawaii
      • Honolulu, Hawaii, Stati Uniti, 96813
        • Queen's Medical Center
      • Honolulu, Hawaii, Stati Uniti, 96813
        • Hawaii Cancer Care Inc - Waterfront Plaza
      • Honolulu, Hawaii, Stati Uniti, 96813
        • Queen's Cancer Cenrer - POB I
      • Honolulu, Hawaii, Stati Uniti, 96813
        • Straub Clinic and Hospital
      • Honolulu, Hawaii, Stati Uniti, 96817
        • Queen's Cancer Center - Kuakini
      • ‘Aiea, Hawaii, Stati Uniti, 96701
        • Hawaii Cancer Care - Westridge
      • ‘Aiea, Hawaii, Stati Uniti, 96701
        • Pali Momi Medical Center
    • Illinois
      • Centralia, Illinois, Stati Uniti, 62801
        • Centralia Oncology Clinic
      • Chicago, Illinois, Stati Uniti, 60611
        • Northwestern University
      • Chicago, Illinois, Stati Uniti, 60637
        • University of Chicago Comprehensive Cancer Center
      • Chicago, Illinois, Stati Uniti, 60612
        • University of Illinois
      • Danville, Illinois, Stati Uniti, 61832
        • Carle at The Riverfront
      • DeKalb, Illinois, Stati Uniti, 60115
        • Northwestern Medicine Cancer Center Kishwaukee
      • Decatur, Illinois, Stati Uniti, 62526
        • Decatur Memorial Hospital
      • Decatur, Illinois, Stati Uniti, 62526
        • Cancer Care Specialists of Illinois - Decatur
      • Effingham, Illinois, Stati Uniti, 62401
        • Crossroads Cancer Center
      • Effingham, Illinois, Stati Uniti, 62401
        • Carle Physician Group-Effingham
      • Evanston, Illinois, Stati Uniti, 60201
        • NorthShore University HealthSystem-Evanston Hospital
      • Geneva, Illinois, Stati Uniti, 60134
        • Northwestern Medicine Cancer Center Delnor
      • Glenview, Illinois, Stati Uniti, 60026
        • NorthShore University HealthSystem-Glenbrook Hospital
      • Glenview, Illinois, Stati Uniti, 60026
        • Northwestern Medicine Glenview Outpatient Center
      • Grayslake, Illinois, Stati Uniti, 60030
        • Northwestern Medicine Grayslake Outpatient Center
      • Highland Park, Illinois, Stati Uniti, 60035
        • NorthShore University HealthSystem-Highland Park Hospital
      • Lake Forest, Illinois, Stati Uniti, 60045
        • Northwestern Medicine Lake Forest Hospital
      • Mattoon, Illinois, Stati Uniti, 61938
        • Carle Physician Group-Mattoon/Charleston
      • New Lenox, Illinois, Stati Uniti, 60451
        • UC Comprehensive Cancer Center at Silver Cross
      • O'Fallon, Illinois, Stati Uniti, 62269
        • Cancer Care Center of O'Fallon
      • Orland Park, Illinois, Stati Uniti, 60462
        • University of Chicago Medicine-Orland Park
      • Orland Park, Illinois, Stati Uniti, 60462
        • Northwestern Medicine Orland Park
      • Peoria, Illinois, Stati Uniti, 61615
        • Illinois CancerCare-Peoria
      • Shiloh, Illinois, Stati Uniti, 62269
        • Memorial Hospital East
      • Urbana, Illinois, Stati Uniti, 61801
        • Carle Cancer Center
      • Warrenville, Illinois, Stati Uniti, 60555
        • Northwestern Medicine Cancer Center Warrenville
    • Iowa
      • Ames, Iowa, Stati Uniti, 50010
        • McFarland Clinic - Ames
      • Ankeny, Iowa, Stati Uniti, 50023
        • UI Health Care Mission Cancer and Blood - Ankeny Clinic
      • Clive, Iowa, Stati Uniti, 50325
        • UI Health Care Mission Cancer and Blood - West Des Moines Clinic
      • Des Moines, Iowa, Stati Uniti, 50309
        • Iowa Methodist Medical Center
      • Des Moines, Iowa, Stati Uniti, 50309
        • UI Health Care Mission Cancer and Blood - Des Moines Clinic
      • Des Moines, Iowa, Stati Uniti, 50314
        • UI Health Care Mission Cancer and Blood - Laurel Clinic
    • Louisiana
      • Monroe, Louisiana, Stati Uniti, 71202
        • Ochsner LSU Health Monroe Medical Center
      • Shreveport, Louisiana, Stati Uniti, 71103
        • LSU Health Sciences Center at Shreveport
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02111
        • Tufts Medical Center
    • Michigan
      • Ann Arbor, Michigan, Stati Uniti, 48106
        • Trinity Health Saint Joseph Mercy Hospital Ann Arbor
      • Brighton, Michigan, Stati Uniti, 48114
        • Trinity Health IHA Medical Group Hematology Oncology - Brighton
      • Brighton, Michigan, Stati Uniti, 48114
        • Trinity Health Medical Center - Brighton
      • Canton, Michigan, Stati Uniti, 48188
        • Trinity Health IHA Medical Group Hematology Oncology - Canton
      • Canton, Michigan, Stati Uniti, 48188
        • Trinity Health Medical Center - Canton
      • Chelsea, Michigan, Stati Uniti, 48118
        • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
      • Chelsea, Michigan, Stati Uniti, 48118
        • Chelsea Hospital
      • Livonia, Michigan, Stati Uniti, 48154
        • Trinity Health Saint Mary Mercy Livonia Hospital
      • Livonia, Michigan, Stati Uniti, 48154
        • Hope Cancer Clinic
      • Ypsilanti, Michigan, Stati Uniti, 48197
        • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
      • Ypsilanti, Michigan, Stati Uniti, 48106
        • Huron Gastroenterology PC
    • Minnesota
      • Deer River, Minnesota, Stati Uniti, 56636
        • Essentia Health - Deer River Clinic
      • Duluth, Minnesota, Stati Uniti, 55805
        • Essentia Health Cancer Center
      • Hibbing, Minnesota, Stati Uniti, 55746
        • Essentia Health Hibbing Clinic
      • Sandstone, Minnesota, Stati Uniti, 55072
        • Essentia Health Sandstone
      • Virginia, Minnesota, Stati Uniti, 55792
        • Essentia Health Virginia Clinic
    • Mississippi
      • Oxford, Mississippi, Stati Uniti, 38655
        • Baptist Memorial Hospital and Cancer Center-Oxford
      • Southhaven, Mississippi, Stati Uniti, 38671
        • Baptist Memorial Hospital and Cancer Center-Desoto
    • Missouri
      • Cape Girardeau, Missouri, Stati Uniti, 63703
        • Saint Francis Medical Center
      • Chesterfield, Missouri, Stati Uniti, 63017
        • Saint Luke's Hospital
      • City of Saint Peters, Missouri, Stati Uniti, 63376
        • Siteman Cancer Center at Saint Peters Hospital
      • Creve Coeur, Missouri, Stati Uniti, 63141
        • Siteman Cancer Center at West County Hospital
      • Saint Joseph, Missouri, Stati Uniti, 64506
        • Heartland Regional Medical Center
      • St Louis, Missouri, Stati Uniti, 63110
        • Washington University School of Medicine
      • St Louis, Missouri, Stati Uniti, 63129
        • Siteman Cancer Center-South County
      • St Louis, Missouri, Stati Uniti, 63136
        • Siteman Cancer Center at Christian Hospital
    • Nebraska
      • Lincoln, Nebraska, Stati Uniti, 68516
        • Cancer Partners of Nebraska
    • New Jersey
      • Basking Ridge, New Jersey, Stati Uniti, 07920
        • Memorial Sloan Kettering Basking Ridge
      • Englewood, New Jersey, Stati Uniti, 07631
        • Englewood Hospital and Medical Center
      • Lakewood, New Jersey, Stati Uniti, 08701
        • Monmouth Medical Center Southern Campus
      • Long Branch, New Jersey, Stati Uniti, 07740
        • Monmouth Medical Center
      • Middletown, New Jersey, Stati Uniti, 07748
        • Memorial Sloan Kettering Monmouth
      • Montvale, New Jersey, Stati Uniti, 07645
        • Memorial Sloan Kettering Bergen
      • New Brunswick, New Jersey, Stati Uniti, 08903
        • Rutgers Cancer Institute of New Jersey
      • Newark, New Jersey, Stati Uniti, 07112
        • Newark Beth Israel Medical Center
      • Toms River, New Jersey, Stati Uniti, 08755
        • Community Medical Center
    • New York
      • Buffalo, New York, Stati Uniti, 14263
        • Roswell Park Cancer Institute
      • Commack, New York, Stati Uniti, 11725
        • Memorial Sloan Kettering Commack
      • Glens Falls, New York, Stati Uniti, 12801
        • Glens Falls Hospital
      • Harrison, New York, Stati Uniti, 10604
        • Memorial Sloan Kettering Westchester
      • Mineola, New York, Stati Uniti, 11501
        • NYU Langone Hospital - Long Island
      • New York, New York, Stati Uniti, 10065
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, Stati Uniti, 10032
        • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
      • New York, New York, Stati Uniti, 10065
        • NYP/Weill Cornell Medical Center
      • New York, New York, Stati Uniti, 10016
        • Laura and Isaac Perlmutter Cancer Center at NYU Langone
      • Oswego, New York, Stati Uniti, 13126
        • Upstate Cancer Center at Oswego
      • Syracuse, New York, Stati Uniti, 13210
        • State University of New York Upstate Medical University
      • Uniondale, New York, Stati Uniti, 11553
        • Memorial Sloan Kettering Nassau
      • Verona, New York, Stati Uniti, 13478
        • Upstate Cancer Center at Verona
    • North Carolina
      • Chapel Hill, North Carolina, Stati Uniti, 27599
        • UNC Lineberger Comprehensive Cancer Center
    • Ohio
      • Cleveland, Ohio, Stati Uniti, 44195
        • Cleveland Clinic Foundation
      • Cleveland, Ohio, Stati Uniti, 44111
        • Cleveland Clinic Cancer Center/Fairview Hospital
      • Columbus, Ohio, Stati Uniti, 43210
        • Ohio State University Comprehensive Cancer Center
      • Dayton, Ohio, Stati Uniti, 45415
        • Dayton Physician LLC - Englewood
      • Independence, Ohio, Stati Uniti, 44131
        • Cleveland Clinic Cancer Center Independence
      • Kettering, Ohio, Stati Uniti, 45409
        • Greater Dayton Cancer Center
      • Mansfield, Ohio, Stati Uniti, 44906
        • Cleveland Clinic Cancer Center Mansfield
      • Mayfield Heights, Ohio, Stati Uniti, 44124
        • Hillcrest Hospital Cancer Center
      • Sandusky, Ohio, Stati Uniti, 44870
        • North Coast Cancer Care
      • Strongsville, Ohio, Stati Uniti, 44136
        • Cleveland Clinic Cancer Center Strongsville
      • Warrensville Heights, Ohio, Stati Uniti, 44122
        • South Pointe Hospital
      • Wooster, Ohio, Stati Uniti, 44691
        • Cleveland Clinic Wooster Family Health and Surgery Center
    • Oklahoma
      • Lawton, Oklahoma, Stati Uniti, 73505
        • Cancer Centers of Southwest Oklahoma Research
      • Oklahoma City, Oklahoma, Stati Uniti, 73104
        • University of Oklahoma Health Sciences Center
    • Oregon
      • Portland, Oregon, Stati Uniti, 97225
        • Providence Saint Vincent Medical Center
      • Portland, Oregon, Stati Uniti, 97239
        • Portland VA Medical Center
    • South Carolina
      • Charleston, South Carolina, Stati Uniti, 29425
        • Medical University of South Carolina
      • Greenville, South Carolina, Stati Uniti, 29607
        • Saint Francis Cancer Center
      • Greenville, South Carolina, Stati Uniti, 29601
        • Saint Francis Hospital
    • Tennessee
      • Memphis, Tennessee, Stati Uniti, 38120
        • Baptist Memorial Hospital and Cancer Center-Memphis
    • Utah
      • Salt Lake City, Utah, Stati Uniti, 84112
        • Huntsman Cancer Institute/University of Utah
      • Salt Lake City, Utah, Stati Uniti, 84148
        • George E Wahlen Department of Veterans Affairs Medical Center
    • Virginia
      • Charlottesville, Virginia, Stati Uniti, 22908
        • University of Virginia Cancer Center
      • Fairfax, Virginia, Stati Uniti, 22031
        • Inova Schar Cancer Institute
      • Richmond, Virginia, Stati Uniti, 23298
        • VCU Massey Comprehensive Cancer Center
    • Washington
      • Bellevue, Washington, Stati Uniti, 98004
        • FHCC Overlake
      • Kirkland, Washington, Stati Uniti, 98034
        • FHCC at EvergreenHealth
      • Seattle, Washington, Stati Uniti, 98133
        • FHCC at Northwest Hospital
    • West Virginia
      • Charleston, West Virginia, Stati Uniti, 25304
        • Vandalia Health/CAMC Institute for Academic Medicine
    • Wisconsin
      • Ashland, Wisconsin, Stati Uniti, 54806
        • Duluth Clinic Ashland
      • Eau Claire, Wisconsin, Stati Uniti, 54701
        • Marshfield Medical Center-EC Cancer Center
      • Green Bay, Wisconsin, Stati Uniti, 54301
        • Saint Vincent Hospital Cancer Center Green Bay
      • Green Bay, Wisconsin, Stati Uniti, 54303
        • Saint Vincent Hospital Cancer Center at Saint Mary's
      • La Crosse, Wisconsin, Stati Uniti, 54601
        • Gundersen Lutheran Medical Center
      • Marshfield, Wisconsin, Stati Uniti, 54449
        • Marshfield Medical Center-Marshfield
      • Minocqua, Wisconsin, Stati Uniti, 54548
        • Marshfield Medical Center - Minocqua
      • Oconto Falls, Wisconsin, Stati Uniti, 54154
        • Saint Vincent Hospital Cancer Center at Oconto Falls
      • Rice Lake, Wisconsin, Stati Uniti, 54868
        • Marshfield Medical Center-Rice Lake
      • Sheboygan, Wisconsin, Stati Uniti, 53081
        • Saint Vincent Hospital Cancer Center at Sheboygan
      • Stevens Point, Wisconsin, Stati Uniti, 54482
        • Marshfield Medical Center-River Region at Stevens Point
      • Sturgeon Bay, Wisconsin, Stati Uniti, 54235-1495
        • Saint Vincent Hospital Cancer Center at Sturgeon Bay
      • Weston, Wisconsin, Stati Uniti, 54476
        • Marshfield Medical Center - Weston

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

75 anni e precedenti (Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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. PET-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. Participants must have measurable disease (at least one lesion with longest diameter ≥ 1.5 cm). 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 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 a history of acute leukemia having been treated with intensive induction therapy. Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial

  • 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 be age ≥ 75

  • 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
    • 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)

  • 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

  • Participants must not have a concurrent primary malignancy undergoing active therapy. Exceptions: participants may have non-melanomatous skin cancers requiring only surgical intervention. Participants may have a history of early stage breast cancer or prostate cancer in remission after surgical and/or radiation therapy on adjuvant hormonal therapy only

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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 rituximab and hyaluronidase human 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. Patients undergo ECHO or MUGA at screening and undergo PET-CT and blood sample collection throughout the study.
Droga: Cyclophosphamide

Given IV

Altri nomi:
  • Cytoxan
  • CTX
  • (-)-ciclofosfamide
  • 2H-1,3,2-ossazafosforina, 2-[bis(2-cloroetil)ammino]tetraidro-, 2-ossido, monoidrato
  • Carloxan
  • Ciclofosfamidica
  • Ciclofosfamide
  • Ciclossale
  • Clafen
  • Clafene
  • CP monoidrato
  • Cella CYCLO
  • Cicloblastina
  • Ciclofosfame
  • Ciclofosfamide monoidrato
  • Ciclofosfamidum
  • Ciclofosfano
  • Ciclofosfanum
  • Ciclostina
  • Citofosfano
  • Fosfaseron
  • Genoxal
  • Genuxale
  • Ledossina
  • Mitoxan
  • Neosar
  • Revimmune
  • Syklofosfamide
  • WR-138719
  • Asta B518
  • B-518
  • B518
  • WR 138719
  • WR138719
  • Frindovyx
Droga: Doxorubicin Hydrochloride

Given IV

Altri nomi:
  • Adriamicina
  • 5,12-naftacenedione, 10-[(3-ammino-2,3,6-trideossi-alfa-L-lisso-esopiranosil)ossi]-7,8, 9,10-tetraidro-6,8,11-triidrossi -8-(idrossiacetil)-1-metossi-, cloridrato, (8S-cis)- (9CI)
  • ADM
  • Adriacin
  • Adriamicina cloridrato
  • Adriamicina PFS
  • Adriamicina RDF
  • ADRIAMICINA, CLORIDRATO
  • Adriblastina
  • Adrimedac
  • Cloridrato di Doxorrubicina
  • DOX
  • DOXO-CELL
  • Doxolem
  • Doxorubicina cloridrato
  • Doxorubicina.HCl
  • Doxorubina
  • Farmiblastina
  • FI 106
  • FI-106
  • idrossidaunorubicina
  • Rubex
  • FI106
Droga: Prednisone

Given PO

Altri nomi:
  • Deltason
  • Orasone
  • .delta.1-Cortisone
  • 1,2-deidrocortisone
  • Adason
  • Cortancyl
  • Dacortin
  • DeCortin
  • Decortisil
  • Decorton
  • Delta 1-cortisone
  • Delta-cupola
  • Deltacortene
  • Deltacortisone
  • Deltadeidrocortisone
  • Deltisone
  • Deltra
  • Econosone
  • Lisacort
  • Meprosona-F
  • Metacortandracina
  • Meticorten
  • Ofisolona
  • Panafcort
  • Panasol-S
  • Paracorto
  • Perrigo Prednisone
  • PRED
  • Predicor
  • Predicorten
  • Prednicen-M
  • Prednicort
  • Prednidib
  • Prednilonga
  • Prednimento
  • Prednisone Intensolo
  • Prednisonum
  • Prednitone
  • Promifen
  • Rayos
  • Servisone
  • SK-Prednisone
Procedura: Biospecimen Collection

Undergo blood sample collection

Altri nomi:
  • Raccolta di campioni biologici
  • Biocampione raccolto
  • Raccolta di campioni
  • Raccolta campione
Biologico: Rituximab

Given IV

Altri nomi:
  • Rituxan
  • MabThera
  • PAB 798
  • BI 695500
  • Anticorpo monoclonale C2B8
  • Anticorpo chimerico anti-CD20
  • CT-P10
  • IDEC-102
  • IDEC-C2B8
  • Anticorpo monoclonale IDEC-C2B8
  • PF-05280586
  • Riabni
  • Rituximab ABBS
  • Rituximab ARX
  • Rituximab biosimilare ABP 798
  • Rituximab Biosimilare BI 695500
  • Rituximab Biosimilare CT-P10
  • Rituximab biosimilare GB241
  • Rituximab biosimilare IBI301
  • Rituximab biosimilare JHL1101
  • Rituximab biosimilare PF-05280586
  • Rituximab biosimilare RTXM83
  • Rituximab biosimilare SAIT101
  • Rituximab biosimilare SIBP-02
  • rituximab biosimilare TQB2303
  • Rituximab PVVR
  • Rituximab-arrx
  • Rituximab-pvvr
  • RTXM83
  • Ruxienza
  • Truxima
  • Rixathon
  • Ikgdar
  • Mabtas
  • Rituximab-abbs
  • BI-695500
  • BI695500
  • Blittima
  • IDEC102
  • PF05280586
  • Ritemvia
  • Rituximab-blit
  • Rito Rituximab
  • Rituximab-rixa
  • Rituximab-rixi
  • Riximyo
  • RTXM-83
  • ABP-798
  • ABP798
  • CT P10
  • CTP10
  • GP2013
  • GP-2013
  • Rituximab biosimilare GP2013
Droga: Vincristine Sulfate

Given IV

Altri nomi:
  • Oncovin
  • Kyocristina
  • Leurocristina solfato
  • Leurocristina, solfato
  • Vincasar
  • Vincosid
  • Vincrex
  • Vincristina, solfato
Altro: Questionnaire Administration

Ancillary studies

Procedura: Echocardiography Test

Undergo ECHO

Altri nomi:
  • Ecocardiografia
  • CE
Procedura: Multigated Acquisition Scan

Undergo MUGA

Altri nomi:
  • Scansione della pozza di sangue
  • Angiografia con radionuclidi di equilibrio
  • Imaging del pool di sangue recintato
  • MUGA
  • Ventricolografia con radionuclidi
  • RNVG
  • Scansione SIMA
  • Scansione di acquisizione multigate sincronizzata
  • Scansione MUGA
  • Scansione di acquisizione multi-gate
  • Scansione del ventricologramma con radionuclidi
  • Scansione del pool cardiaco recintato
  • Scansione RNV
Procedura: Positron Emission Tomography

Undergo PET-CT

Altri nomi:
  • Imaging medico, tomografia a emissione di positroni
  • ANIMALE DOMESTICO
  • Scansione animale
  • Scansione di tomografia a emissione di positroni
  • Tomografia ad emissione di positroni
  • P.T
  • Tomografia a emissione di positroni (procedura)
Biologico: Rituximab and Hyaluronidase Human

Given SC

Altri nomi:
  • Rituxan Hycela
  • Rituximab Plus Ialuronidasi
  • Rituximab/Ialuronidasi
  • Rituximab/ialuronidasi umana
Procedura: Computed Tomography

Undergo PET-CT

Altri nomi:
  • CT
  • GATTO
  • TAC
  • Tomografia assiale computerizzata
  • Tomografia computerizzata
  • tomografia
  • Tomografia assiale computerizzata (procedura)
  • Scansione tomografia computerizzata (CT).
  • Scansione CAT diagnostica
  • Tipo di servizio di scansione CAT diagnostica
Droga: Oral Azacitidine

Given PO

Altri nomi:
  • Onureg
  • CC-486
  • Azacitidina orale
  • CC 486
  • CC486
Comparatore attivo: Arm II (R-miniCHOP)

Patients receive rituximab IV (or rituximab and hyaluronidase human 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. Patients undergo ECHO or MUGA at screening and undergo PET-CT and blood sample collection throughout the study.
Droga: Cyclophosphamide

Given IV

Altri nomi:
  • Cytoxan
  • CTX
  • (-)-ciclofosfamide
  • 2H-1,3,2-ossazafosforina, 2-[bis(2-cloroetil)ammino]tetraidro-, 2-ossido, monoidrato
  • Carloxan
  • Ciclofosfamidica
  • Ciclofosfamide
  • Ciclossale
  • Clafen
  • Clafene
  • CP monoidrato
  • Cella CYCLO
  • Cicloblastina
  • Ciclofosfame
  • Ciclofosfamide monoidrato
  • Ciclofosfamidum
  • Ciclofosfano
  • Ciclofosfanum
  • Ciclostina
  • Citofosfano
  • Fosfaseron
  • Genoxal
  • Genuxale
  • Ledossina
  • Mitoxan
  • Neosar
  • Revimmune
  • Syklofosfamide
  • WR-138719
  • Asta B518
  • B-518
  • B518
  • WR 138719
  • WR138719
  • Frindovyx
Droga: Doxorubicin Hydrochloride

Given IV

Altri nomi:
  • Adriamicina
  • 5,12-naftacenedione, 10-[(3-ammino-2,3,6-trideossi-alfa-L-lisso-esopiranosil)ossi]-7,8, 9,10-tetraidro-6,8,11-triidrossi -8-(idrossiacetil)-1-metossi-, cloridrato, (8S-cis)- (9CI)
  • ADM
  • Adriacin
  • Adriamicina cloridrato
  • Adriamicina PFS
  • Adriamicina RDF
  • ADRIAMICINA, CLORIDRATO
  • Adriblastina
  • Adrimedac
  • Cloridrato di Doxorrubicina
  • DOX
  • DOXO-CELL
  • Doxolem
  • Doxorubicina cloridrato
  • Doxorubicina.HCl
  • Doxorubina
  • Farmiblastina
  • FI 106
  • FI-106
  • idrossidaunorubicina
  • Rubex
  • FI106
Droga: Prednisone

Given PO

Altri nomi:
  • Deltason
  • Orasone
  • .delta.1-Cortisone
  • 1,2-deidrocortisone
  • Adason
  • Cortancyl
  • Dacortin
  • DeCortin
  • Decortisil
  • Decorton
  • Delta 1-cortisone
  • Delta-cupola
  • Deltacortene
  • Deltacortisone
  • Deltadeidrocortisone
  • Deltisone
  • Deltra
  • Econosone
  • Lisacort
  • Meprosona-F
  • Metacortandracina
  • Meticorten
  • Ofisolona
  • Panafcort
  • Panasol-S
  • Paracorto
  • Perrigo Prednisone
  • PRED
  • Predicor
  • Predicorten
  • Prednicen-M
  • Prednicort
  • Prednidib
  • Prednilonga
  • Prednimento
  • Prednisone Intensolo
  • Prednisonum
  • Prednitone
  • Promifen
  • Rayos
  • Servisone
  • SK-Prednisone
Procedura: Biospecimen Collection

Undergo blood sample collection

Altri nomi:
  • Raccolta di campioni biologici
  • Biocampione raccolto
  • Raccolta di campioni
  • Raccolta campione
Biologico: Rituximab

Given IV

Altri nomi:
  • Rituxan
  • MabThera
  • PAB 798
  • BI 695500
  • Anticorpo monoclonale C2B8
  • Anticorpo chimerico anti-CD20
  • CT-P10
  • IDEC-102
  • IDEC-C2B8
  • Anticorpo monoclonale IDEC-C2B8
  • PF-05280586
  • Riabni
  • Rituximab ABBS
  • Rituximab ARX
  • Rituximab biosimilare ABP 798
  • Rituximab Biosimilare BI 695500
  • Rituximab Biosimilare CT-P10
  • Rituximab biosimilare GB241
  • Rituximab biosimilare IBI301
  • Rituximab biosimilare JHL1101
  • Rituximab biosimilare PF-05280586
  • Rituximab biosimilare RTXM83
  • Rituximab biosimilare SAIT101
  • Rituximab biosimilare SIBP-02
  • rituximab biosimilare TQB2303
  • Rituximab PVVR
  • Rituximab-arrx
  • Rituximab-pvvr
  • RTXM83
  • Ruxienza
  • Truxima
  • Rixathon
  • Ikgdar
  • Mabtas
  • Rituximab-abbs
  • BI-695500
  • BI695500
  • Blittima
  • IDEC102
  • PF05280586
  • Ritemvia
  • Rituximab-blit
  • Rito Rituximab
  • Rituximab-rixa
  • Rituximab-rixi
  • Riximyo
  • RTXM-83
  • ABP-798
  • ABP798
  • CT P10
  • CTP10
  • GP2013
  • GP-2013
  • Rituximab biosimilare GP2013
Droga: Vincristine Sulfate

Given IV

Altri nomi:
  • Oncovin
  • Kyocristina
  • Leurocristina solfato
  • Leurocristina, solfato
  • Vincasar
  • Vincosid
  • Vincrex
  • Vincristina, solfato
Altro: Questionnaire Administration

Ancillary studies

Procedura: Echocardiography Test

Undergo ECHO

Altri nomi:
  • Ecocardiografia
  • CE
Procedura: Multigated Acquisition Scan

Undergo MUGA

Altri nomi:
  • Scansione della pozza di sangue
  • Angiografia con radionuclidi di equilibrio
  • Imaging del pool di sangue recintato
  • MUGA
  • Ventricolografia con radionuclidi
  • RNVG
  • Scansione SIMA
  • Scansione di acquisizione multigate sincronizzata
  • Scansione MUGA
  • Scansione di acquisizione multi-gate
  • Scansione del ventricologramma con radionuclidi
  • Scansione del pool cardiaco recintato
  • Scansione RNV
Procedura: Positron Emission Tomography

Undergo PET-CT

Altri nomi:
  • Imaging medico, tomografia a emissione di positroni
  • ANIMALE DOMESTICO
  • Scansione animale
  • Scansione di tomografia a emissione di positroni
  • Tomografia ad emissione di positroni
  • P.T
  • Tomografia a emissione di positroni (procedura)
Biologico: Rituximab and Hyaluronidase Human

Given SC

Altri nomi:
  • Rituxan Hycela
  • Rituximab Plus Ialuronidasi
  • Rituximab/Ialuronidasi
  • Rituximab/ialuronidasi umana
Procedura: Computed Tomography

Undergo PET-CT

Altri nomi:
  • CT
  • GATTO
  • TAC
  • Tomografia assiale computerizzata
  • Tomografia computerizzata
  • tomografia
  • Tomografia assiale computerizzata (procedura)
  • Scansione tomografia computerizzata (CT).
  • Scansione CAT diagnostica
  • Tipo di servizio di scansione CAT diagnostica

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Metabolic complete response (CR)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Changes in function (Integrated Correlative Geriatric Assessments Substudy)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

National Cancer Institute (NCI)

Investigatori

  • Investigatore principale: Elizabeth A Brem, SWOG Cancer Research Network

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

20 maggio 2021

Completamento primario (Stimato)

1 marzo 2027

Completamento dello studio (Stimato)

1 marzo 2027

Date di iscrizione allo studio

Primo inviato

13 marzo 2021

Primo inviato che soddisfa i criteri di controllo qualità

13 marzo 2021

Primo Inserito (Effettivo)

16 marzo 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

27 ottobre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 ottobre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • NCI-2020-01256
  • U10CA180888 (Sovvenzione/contratto NIH degli Stati Uniti)
  • NCI-2020-01256 (Identificatore di registro: CTRP (Clinical Trial Reporting Program))
  • S1918 (Altro identificatore: CTEP)
  • S1918 (Altro identificatore: SWOG)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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