New combo therapy aims to extend remission in elderly lymphoma patients

NCT ID NCT04799275

Disease control Sponsor: National Cancer Institute (NCI) Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 09, 2026 · Updated 2 times

Summary

This study is for people aged 75 or older who have been newly diagnosed with certain aggressive types of B-cell lymphoma. It tests whether adding an oral medication (CC-486, or oral azacitidine) to the standard reduced-dose chemotherapy regimen (R-miniCHOP) can help keep the cancer from returning or improve survival. About 422 participants will be randomly assigned to receive either the standard treatment alone or the standard treatment plus the oral drug. The goal is to see if the combination is more effective and safe for this older population.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 422 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2021

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

75 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

diffuse large B-cell lymphoma diffuse large B-cell lymphoma activated B-cell type diffuse large B-cell lymphoma germinal center B-cell type diffuse large B-cell lymphoma with chronic inflammation Epstein-Barr virus-positive diffuse large B-cell lymphoma of the elderly follicular lymphoma high grade B-cell lymphoma high grade B-cell lymphoma with MYC and/ or BCL2 and/or BCL6 rearrangement intravascular large B-cell lymphoma Lymphoma, B-Cell, Marginal Zone lymphoplasmacytic lymphoma nodular lymphocyte predominant Hodgkin lymphoma primary cutaneous diffuse large B-cell lymphoma, Leg type Richter transformation T-cell/histiocyte rich large B cell lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

Augusta University Medical Center

Augusta, Georgia, 30912, United States
Banner University Medical Center - Tucson

Tucson, Arizona, 85719, United States
Baptist Memorial Hospital and Cancer Center-Desoto

Southhaven, Mississippi, 38671, United States
Baptist Memorial Hospital and Cancer Center-Memphis

Memphis, Tennessee, 38120, United States
Baptist Memorial Hospital and Cancer Center-Oxford

Oxford, Mississippi, 38655, United States
Cancer Care Center of O'Fallon

O'Fallon, Illinois, 62269, United States
Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, 62526, United States
Cancer Centers of Southwest Oklahoma Research

Lawton, Oklahoma, 73505, United States
Cancer Partners of Nebraska

Lincoln, Nebraska, 68516, United States
Carle Cancer Center

Urbana, Illinois, 61801, United States
Carle Physician Group-Effingham

Effingham, Illinois, 62401, United States
Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, 61938, United States
Carle at The Riverfront

Danville, Illinois, 61832, United States
Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States
Centralia Oncology Clinic

Centralia, Illinois, 62801, United States
Chelsea Hospital

Chelsea, Michigan, 48118, United States
City of Hope Antelope Valley

Lancaster, California, 93534, United States
City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States
City of Hope Newport Beach

Newport Beach, California, 92660, United States
City of Hope Seacliff

Huntington Beach, California, 92648, United States
City of Hope South Bay

Torrance, California, 90503, United States
City of Hope South Pasadena

South Pasadena, California, 91030, United States
City of Hope Upland

Upland, California, 91786, United States
City of Hope at Irvine Lennar

Irvine, California, 92618, United States
City of Hope at Long Beach Elm

Long Beach, California, 90813, United States
Cleveland Clinic Cancer Center Independence

Independence, Ohio, 44131, United States
Cleveland Clinic Cancer Center Mansfield

Mansfield, Ohio, 44906, United States
Cleveland Clinic Cancer Center Strongsville

Strongsville, Ohio, 44136, United States
Cleveland Clinic Cancer Center/Fairview Hospital

Cleveland, Ohio, 44111, United States
Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States
Cleveland Clinic Wooster Family Health and Surgery Center

Wooster, Ohio, 44691, United States
Community Medical Center

Toms River, New Jersey, 08755, United States
Crossroads Cancer Center

Effingham, Illinois, 62401, United States
Dayton Physician LLC - Englewood

Dayton, Ohio, 45415, United States
Decatur Memorial Hospital

Decatur, Illinois, 62526, United States
Delaware Clinical and Laboratory Physicians PA

Newark, Delaware, 19713, United States
Duluth Clinic Ashland

Ashland, Wisconsin, 54806, United States
Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342, United States
Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States
Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States
Englewood Hospital and Medical Center

Englewood, New Jersey, 07631, United States
Essentia Health - Deer River Clinic

Deer River, Minnesota, 56636, United States
Essentia Health Cancer Center

Duluth, Minnesota, 55805, United States
Essentia Health Hibbing Clinic

Hibbing, Minnesota, 55746, United States
Essentia Health Sandstone

Sandstone, Minnesota, 55072, United States
Essentia Health Virginia Clinic

Virginia, Minnesota, 55792, United States
FHCC Overlake

Bellevue, Washington, 98004, United States
FHCC at EvergreenHealth

Kirkland, Washington, 98034, United States
FHCC at Northwest Hospital

Seattle, Washington, 98133, United States
George E Wahlen Department of Veterans Affairs Medical Center

Salt Lake City, Utah, 84148, United States
Glens Falls Hospital

Glens Falls, New York, 12801, United States
Greater Dayton Cancer Center

Kettering, Ohio, 45409, United States
Gundersen Lutheran Medical Center

La Crosse, Wisconsin, 54601, United States
Hawaii Cancer Care - Westridge

‘Aiea, Hawaii, 96701, United States
Hawaii Cancer Care Inc - Waterfront Plaza

Honolulu, Hawaii, 96813, United States
Heartland Regional Medical Center

Saint Joseph, Missouri, 64506, United States
Helen F Graham Cancer Center

Newark, Delaware, 19713, United States
Hillcrest Hospital Cancer Center

Mayfield Heights, Ohio, 44124, United States
Hope Cancer Clinic

Livonia, Michigan, 48154, United States
Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112, United States
Huron Gastroenterology PC

Ypsilanti, Michigan, 48106, United States
Illinois CancerCare-Peoria

Peoria, Illinois, 61615, United States
Inova Schar Cancer Institute

Fairfax, Virginia, 22031, United States
Iowa Methodist Medical Center

Des Moines, Iowa, 50309, United States
Kaiser Permanente - Panorama City

Panorama City, California, 91402, United States
Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, 90027, United States
Kaiser Permanente South Bay

Harbor City, California, 90710, United States
Kaiser Permanente West Los Angeles

Los Angeles, California, 90034, United States
Kaiser Permanente-Anaheim

Anaheim, California, 92806, United States
Kaiser Permanente-Baldwin Park

Baldwin Park, California, 91706, United States
Kaiser Permanente-Bellflower

Bellflower, California, 90706, United States
Kaiser Permanente-Fontana

Fontana, California, 92335, United States
Kaiser Permanente-Irvine

Irvine, California, 92618, United States
Kaiser Permanente-Ontario

Ontario, California, 91761, United States
Kaiser Permanente-Riverside

Riverside, California, 92505, United States
Kaiser Permanente-San Diego Zion

San Diego, California, 92120, United States
Kaiser Permanente-San Marcos

San Marcos, California, 92078, United States
Kaiser Permanente-Woodland Hills

Woodland Hills, California, 91367, United States
LSU Health Sciences Center at Shreveport

Shreveport, Louisiana, 71103, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, 10016, United States
Lutheran Hospital - Cancer Centers of Colorado

Golden, Colorado, 80401, United States
Marshfield Medical Center - Minocqua

Minocqua, Wisconsin, 54548, United States
Marshfield Medical Center - Weston

Weston, Wisconsin, 54476, United States
Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin, 54701, United States
Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, 54449, United States
Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin, 54868, United States
Marshfield Medical Center-River Region at Stevens Point

Stevens Point, Wisconsin, 54482, United States
McFarland Clinic - Ames

Ames, Iowa, 50010, United States
Medical Oncology Hematology Consultants PA

Newark, Delaware, 19713, United States
Medical University of South Carolina

Charleston, South Carolina, 29425, United States
Memorial Hospital East

Shiloh, Illinois, 62269, United States
Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States
Memorial Sloan Kettering Commack

Commack, New York, 11725, United States
Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Nassau

Uniondale, New York, 11553, United States
Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States
Monmouth Medical Center

Long Branch, New Jersey, 07740, United States
Monmouth Medical Center Southern Campus

Lakewood, New Jersey, 08701, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

New York, New York, 10032, United States
NYP/Weill Cornell Medical Center

New York, New York, 10065, United States
NYU Langone Hospital - Long Island

Mineola, New York, 11501, United States
Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States
North Coast Cancer Care

Sandusky, Ohio, 44870, United States
NorthShore University HealthSystem-Evanston Hospital

Evanston, Illinois, 60201, United States
NorthShore University HealthSystem-Glenbrook Hospital

Glenview, Illinois, 60026, United States
NorthShore University HealthSystem-Highland Park Hospital

Highland Park, Illinois, 60035, United States
Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, 60134, United States
Northwestern Medicine Cancer Center Kishwaukee

DeKalb, Illinois, 60115, United States
Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, 60555, United States
Northwestern Medicine Glenview Outpatient Center

Glenview, Illinois, 60026, United States
Northwestern Medicine Grayslake Outpatient Center

Grayslake, Illinois, 60030, United States
Northwestern Medicine Lake Forest Hospital

Lake Forest, Illinois, 60045, United States
Northwestern Medicine Orland Park

Orland Park, Illinois, 60462, United States
Northwestern University

Chicago, Illinois, 60611, United States
Ochsner LSU Health Monroe Medical Center

Monroe, Louisiana, 71202, United States
Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States
Pali Momi Medical Center

‘Aiea, Hawaii, 96701, United States
Portland VA Medical Center

Portland, Oregon, 97239, United States
Providence Saint Vincent Medical Center

Portland, Oregon, 97225, United States
Queen's Cancer Cenrer - POB I

Honolulu, Hawaii, 96813, United States
Queen's Cancer Center - Kuakini

Honolulu, Hawaii, 96817, United States
Queen's Medical Center

Honolulu, Hawaii, 96813, United States
Roswell Park Cancer Institute

Buffalo, New York, 14263, United States
Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States
Saint Francis Cancer Center

Greenville, South Carolina, 29607, United States
Saint Francis Hospital

Greenville, South Carolina, 29601, United States
Saint Francis Medical Center

Cape Girardeau, Missouri, 63703, United States
Saint Luke's Hospital

Chesterfield, Missouri, 63017, United States
Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, 54301, United States
Saint Vincent Hospital Cancer Center at Oconto Falls

Oconto Falls, Wisconsin, 54154, United States
Saint Vincent Hospital Cancer Center at Saint Mary's

Green Bay, Wisconsin, 54303, United States
Saint Vincent Hospital Cancer Center at Sheboygan

Sheboygan, Wisconsin, 53081, United States
Saint Vincent Hospital Cancer Center at Sturgeon Bay

Sturgeon Bay, Wisconsin, 54235-1495, United States
Siteman Cancer Center at Christian Hospital

St Louis, Missouri, 63136, United States
Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, 63376, United States
Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, 63141, United States
Siteman Cancer Center-South County

St Louis, Missouri, 63129, United States
South Pointe Hospital

Warrensville Heights, Ohio, 44122, United States
Stanford Cancer Institute Palo Alto

Palo Alto, California, 94304, United States
State University of New York Upstate Medical University

Syracuse, New York, 13210, United States
Straub Clinic and Hospital

Honolulu, Hawaii, 96813, United States
Tibor Rubin VA Medical Center

Long Beach, California, 90822, United States
Tower Cancer Research Foundation

Beverly Hills, California, 90211, United States
Trinity Health IHA Medical Group Hematology Oncology - Brighton

Brighton, Michigan, 48114, United States
Trinity Health IHA Medical Group Hematology Oncology - Canton

Canton, Michigan, 48188, United States
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Chelsea, Michigan, 48118, United States
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Ypsilanti, Michigan, 48197, United States
Trinity Health Medical Center - Brighton

Brighton, Michigan, 48114, United States
Trinity Health Medical Center - Canton

Canton, Michigan, 48188, United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, 48106, United States
Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, 48154, United States
Tufts Medical Center

Boston, Massachusetts, 02111, United States
UC Comprehensive Cancer Center at Silver Cross

New Lenox, Illinois, 60451, United States
UC Irvine Health Cancer Center-Newport

Costa Mesa, California, 92627, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States
UCSF Cancer Center - San Mateo

San Mateo, California, 94402, United States
UI Health Care Mission Cancer and Blood - Ankeny Clinic

Ankeny, Iowa, 50023, United States
UI Health Care Mission Cancer and Blood - Des Moines Clinic

Des Moines, Iowa, 50309, United States
UI Health Care Mission Cancer and Blood - Laurel Clinic

Des Moines, Iowa, 50314, United States
UI Health Care Mission Cancer and Blood - West Des Moines Clinic

Clive, Iowa, 50325, United States
UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States
University of Arizona Cancer Center-North Campus

Tucson, Arizona, 85719, United States
University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States
University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States
University of Chicago Medicine-Orland Park

Orland Park, Illinois, 60462, United States
University of Illinois

Chicago, Illinois, 60612, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136, United States
University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States
University of Virginia Cancer Center

Charlottesville, Virginia, 22908, United States
Upstate Cancer Center at Oswego

Oswego, New York, 13126, United States
Upstate Cancer Center at Verona

Verona, New York, 13478, United States
VCU Massey Comprehensive Cancer Center

Richmond, Virginia, 23298, United States
Washington University School of Medicine

St Louis, Missouri, 63110, United States
West Virginia University Charleston Division

Charleston, West Virginia, 25304, United States

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