ClinicalTrials.gov record
Testing CC-486 (Oral Azacitidine) Plus the Standard Drug Therapy in Patients 75 Years or Older With Newly Diagnosed Diffuse Large B Cell Lymphoma
ClinicalTrials.gov ID: NCT04799275
Public ClinicalTrials.gov record NCT04799275. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase II/III Randomized Study of R-MiniCHOP With or Without CC-486 (Oral Azacitidine) in Participants Age 75 Years or Older With Newly Diagnosed Diffuse Large B Cell Lymphoma, Grade IIIB Follicular Lymphoma, Transformed Lymphoma, and High-Grade B-Cell Lymphomas With MYC AND BCL2 and/or BCL6 Rearrangements
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04799275
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 422 participants
Conditions and interventions
Conditions
- Ann Arbor Stage III Diffuse Large B-Cell Lymphoma
- Ann Arbor Stage IIX (Bulky) Diffuse Large B-Cell Lymphoma
- Ann Arbor Stage IV Diffuse Large B-Cell Lymphoma
- Diffuse Large B-Cell Lymphoma Activated B-Cell Type
- Diffuse Large B-Cell Lymphoma Associated With Chronic Inflammation
- Diffuse Large B-Cell Lymphoma Germinal Center B-Cell Type
- Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
- EBV-Positive Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
- Grade 3b Follicular Lymphoma
- HHV8-Positive Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
- High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements
- High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
- High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements
- High Grade B-Cell Lymphoma, Not Otherwise Specified
- Intravascular Large B-Cell Lymphoma
- Lymphoplasmacytic Lymphoma
- Nodular Lymphocyte Predominant B-Cell Lymphoma
- Primary Cutaneous Diffuse Large B-Cell Lymphoma, Leg Type
- T-Cell/Histiocyte-Rich Large B-Cell Lymphoma
- Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma
- Transformed Marginal Zone Lymphoma to Diffuse Large B-Cell Lymphoma
Interventions
- Biospecimen Collection Procedure
- Computed Tomography Procedure
- Cyclophosphamide Drug
- Doxorubicin Hydrochloride Drug
- Echocardiography Test Procedure
- Multigated Acquisition Scan Procedure
- Oral Azacitidine Drug
- Positron Emission Tomography Procedure
- Prednisone Drug
- Questionnaire Administration Other
- Rituximab Biological
- Rituximab and Hyaluronidase Human Biological
- Vincristine Sulfate Drug
Procedure · Drug · Other + 1 more
Eligibility (public fields only)
- Age range
- 75 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 20, 2021 (Actual)
- Primary completion
- Mar 1, 2027 (Estimated)
- Completion
- Mar 1, 2027 (Estimated)
- Last update posted
- Oct 1, 2026
2021 – 2027
United States locations
- U.S. sites
- 176
- U.S. states
- 30
- U.S. cities
- 139
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Banner University Medical Center - Tucson | Tucson | Arizona | 85719 | — |
| University of Arizona Cancer Center-North Campus | Tucson | Arizona | 85719 | — |
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | — |
| Kaiser Permanente-Anaheim | Anaheim | California | 92806 | — |
| Kaiser Permanente-Baldwin Park | Baldwin Park | California | 91706 | — |
| Kaiser Permanente-Bellflower | Bellflower | California | 90706 | — |
| Tower Cancer Research Foundation | Beverly Hills | California | 90211 | — |
| UC Irvine Health Cancer Center-Newport | Costa Mesa | California | 92627 | — |
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010 | — |
| Kaiser Permanente-Fontana | Fontana | California | 92335 | — |
| Kaiser Permanente South Bay | Harbor City | California | 90710 | — |
| City of Hope Seacliff | Huntington Beach | California | 92648 | — |
| City of Hope at Irvine Lennar | Irvine | California | 92618 | — |
| Kaiser Permanente-Irvine | Irvine | California | 92618 | — |
| City of Hope Antelope Valley | Lancaster | California | 93534 | — |
| City of Hope at Long Beach Elm | Long Beach | California | 90813 | — |
| Tibor Rubin VA Medical Center | Long Beach | California | 90822 | — |
| Kaiser Permanente Los Angeles Medical Center | Los Angeles | California | 90027 | — |
| Kaiser Permanente West Los Angeles | Los Angeles | California | 90034 | — |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | — |
| City of Hope Newport Beach | Newport Beach | California | 92660 | — |
| Kaiser Permanente-Ontario | Ontario | California | 91761 | — |
| UC Irvine Health/Chao Family Comprehensive Cancer Center | Orange | California | 92868 | — |
| Stanford Cancer Institute Palo Alto | Palo Alto | California | 94304 | — |
| Kaiser Permanente - Panorama City | Panorama City | California | 91402 | — |
| Kaiser Permanente-Riverside | Riverside | California | 92505 | — |
| Kaiser Permanente-San Diego Zion | San Diego | California | 92120 | — |
| Kaiser Permanente-San Marcos | San Marcos | California | 92078 | — |
| UCSF Cancer Center - San Mateo | San Mateo | California | 94402 | — |
| City of Hope South Pasadena | South Pasadena | California | 91030 | — |
| City of Hope South Bay | Torrance | California | 90503 | — |
| City of Hope Upland | Upland | California | 91786 | — |
| Kaiser Permanente-Woodland Hills | Woodland Hills | California | 91367 | — |
| Lutheran Hospital - Cancer Centers of Colorado | Golden | Colorado | 80401 | — |
| Delaware Clinical and Laboratory Physicians PA | Newark | Delaware | 19713 | — |
| Helen F Graham Cancer Center | Newark | Delaware | 19713 | — |
| Medical Oncology Hematology Consultants PA | Newark | Delaware | 19713 | — |
| University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami | Florida | 33136 | — |
| Emory University Hospital Midtown | Atlanta | Georgia | 30308 | — |
| Emory University Hospital/Winship Cancer Institute | Atlanta | Georgia | 30322 | — |
| Emory Saint Joseph's Hospital | Atlanta | Georgia | 30342 | — |
| Augusta University Medical Center | Augusta | Georgia | 30912 | — |
| Hawaii Cancer Care Inc - Waterfront Plaza | Honolulu | Hawaii | 96813 | — |
| Queen's Cancer Cenrer - POB I | Honolulu | Hawaii | 96813 | — |
| Queen's Medical Center | Honolulu | Hawaii | 96813 | — |
| Straub Clinic and Hospital | Honolulu | Hawaii | 96813 | — |
| Queen's Cancer Center - Kuakini | Honolulu | Hawaii | 96817 | — |
| Hawaii Cancer Care - Westridge | ‘Aiea | Hawaii | 96701 | — |
| Pali Momi Medical Center | ‘Aiea | Hawaii | 96701 | — |
| Centralia Oncology Clinic | Centralia | Illinois | 62801 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| University of Illinois | Chicago | Illinois | 60612 | — |
| University of Chicago Comprehensive Cancer Center | Chicago | Illinois | 60637 | — |
| Carle at The Riverfront | Danville | Illinois | 61832 | — |
| Cancer Care Specialists of Illinois - Decatur | Decatur | Illinois | 62526 | — |
| Decatur Memorial Hospital | Decatur | Illinois | 62526 | — |
| Northwestern Medicine Cancer Center Kishwaukee | DeKalb | Illinois | 60115 | — |
| Carle Physician Group-Effingham | Effingham | Illinois | 62401 | — |
| Crossroads Cancer Center | Effingham | Illinois | 62401 | — |
| NorthShore University HealthSystem-Evanston Hospital | Evanston | Illinois | 60201 | — |
| Northwestern Medicine Cancer Center Delnor | Geneva | Illinois | 60134 | — |
| NorthShore University HealthSystem-Glenbrook Hospital | Glenview | Illinois | 60026 | — |
| Northwestern Medicine Glenview Outpatient Center | Glenview | Illinois | 60026 | — |
| Northwestern Medicine Grayslake Outpatient Center | Grayslake | Illinois | 60030 | — |
| NorthShore University HealthSystem-Highland Park Hospital | Highland Park | Illinois | 60035 | — |
| Northwestern Medicine Lake Forest Hospital | Lake Forest | Illinois | 60045 | — |
| Carle Physician Group-Mattoon/Charleston | Mattoon | Illinois | 61938 | — |
| UC Comprehensive Cancer Center at Silver Cross | New Lenox | Illinois | 60451 | — |
| Cancer Care Center of O'Fallon | O'Fallon | Illinois | 62269 | — |
| Northwestern Medicine Orland Park | Orland Park | Illinois | 60462 | — |
| University of Chicago Medicine-Orland Park | Orland Park | Illinois | 60462 | — |
| Illinois CancerCare-Peoria | Peoria | Illinois | 61615 | — |
| Memorial Hospital East | Shiloh | Illinois | 62269 | — |
| Carle Cancer Center | Urbana | Illinois | 61801 | — |
| Northwestern Medicine Cancer Center Warrenville | Warrenville | Illinois | 60555 | — |
| McFarland Clinic - Ames | Ames | Iowa | 50010 | — |
| UI Health Care Mission Cancer and Blood - Ankeny Clinic | Ankeny | Iowa | 50023 | — |
| UI Health Care Mission Cancer and Blood - West Des Moines Clinic | Clive | Iowa | 50325 | — |
| Iowa Methodist Medical Center | Des Moines | Iowa | 50309 | — |
| UI Health Care Mission Cancer and Blood - Des Moines Clinic | Des Moines | Iowa | 50309 | — |
| UI Health Care Mission Cancer and Blood - Laurel Clinic | Des Moines | Iowa | 50314 | — |
| Ochsner LSU Health Monroe Medical Center | Monroe | Louisiana | 71202 | — |
| LSU Health Sciences Center at Shreveport | Shreveport | Louisiana | 71103 | — |
| Tufts Medical Center | Boston | Massachusetts | 02111 | — |
| Trinity Health Saint Joseph Mercy Hospital Ann Arbor | Ann Arbor | Michigan | 48106 | — |
| Trinity Health IHA Medical Group Hematology Oncology - Brighton | Brighton | Michigan | 48114 | — |
| Trinity Health Medical Center - Brighton | Brighton | Michigan | 48114 | — |
| Trinity Health IHA Medical Group Hematology Oncology - Canton | Canton | Michigan | 48188 | — |
| Trinity Health Medical Center - Canton | Canton | Michigan | 48188 | — |
| Chelsea Hospital | Chelsea | Michigan | 48118 | — |
| Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital | Chelsea | Michigan | 48118 | — |
| Hope Cancer Clinic | Livonia | Michigan | 48154 | — |
| Trinity Health Saint Mary Mercy Livonia Hospital | Livonia | Michigan | 48154 | — |
| Huron Gastroenterology PC | Ypsilanti | Michigan | 48106 | — |
| Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus | Ypsilanti | Michigan | 48197 | — |
| Essentia Health - Deer River Clinic | Deer River | Minnesota | 56636 | — |
| Essentia Health Cancer Center | Duluth | Minnesota | 55805 | — |
| Essentia Health Hibbing Clinic | Hibbing | Minnesota | 55746 | — |
| Essentia Health Sandstone | Sandstone | Minnesota | 55072 | — |
| Essentia Health Virginia Clinic | Virginia | Minnesota | 55792 | — |
| Baptist Memorial Hospital and Cancer Center-Oxford | Oxford | Mississippi | 38655 | — |
| Baptist Memorial Hospital and Cancer Center-Desoto | Southhaven | Mississippi | 38671 | — |
| Saint Francis Medical Center | Cape Girardeau | Missouri | 63703 | — |
| Saint Luke's Hospital | Chesterfield | Missouri | 63017 | — |
| Siteman Cancer Center at Saint Peters Hospital | City of Saint Peters | Missouri | 63376 | — |
| Siteman Cancer Center at West County Hospital | Creve Coeur | Missouri | 63141 | — |
| Heartland Regional Medical Center | Saint Joseph | Missouri | 64506 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Siteman Cancer Center-South County | St Louis | Missouri | 63129 | — |
| Siteman Cancer Center at Christian Hospital | St Louis | Missouri | 63136 | — |
| Cancer Partners of Nebraska | Lincoln | Nebraska | 68516 | — |
| Memorial Sloan Kettering Basking Ridge | Basking Ridge | New Jersey | 07920 | — |
| Englewood Hospital and Medical Center | Englewood | New Jersey | 07631 | — |
| Monmouth Medical Center Southern Campus | Lakewood | New Jersey | 08701 | — |
| Monmouth Medical Center | Long Branch | New Jersey | 07740 | — |
| Memorial Sloan Kettering Monmouth | Middletown | New Jersey | 07748 | — |
| Memorial Sloan Kettering Bergen | Montvale | New Jersey | 07645 | — |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | — |
| Newark Beth Israel Medical Center | Newark | New Jersey | 07112 | — |
| Community Medical Center | Toms River | New Jersey | 08755 | — |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | — |
| Memorial Sloan Kettering Commack | Commack | New York | 11725 | — |
| Glens Falls Hospital | Glens Falls | New York | 12801 | — |
| Memorial Sloan Kettering Westchester | Harrison | New York | 10604 | — |
| NYU Langone Hospital - Long Island | Mineola | New York | 11501 | — |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone | New York | New York | 10016 | — |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York | New York | 10032 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| NYP/Weill Cornell Medical Center | New York | New York | 10065 | — |
| Upstate Cancer Center at Oswego | Oswego | New York | 13126 | — |
| State University of New York Upstate Medical University | Syracuse | New York | 13210 | — |
| Memorial Sloan Kettering Nassau | Uniondale | New York | 11553 | — |
| Upstate Cancer Center at Verona | Verona | New York | 13478 | — |
| UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27599 | — |
| Cleveland Clinic Cancer Center/Fairview Hospital | Cleveland | Ohio | 44111 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | — |
| Dayton Physician LLC - Englewood | Dayton | Ohio | 45415 | — |
| Cleveland Clinic Cancer Center Independence | Independence | Ohio | 44131 | — |
| Greater Dayton Cancer Center | Kettering | Ohio | 45409 | — |
| Cleveland Clinic Cancer Center Mansfield | Mansfield | Ohio | 44906 | — |
| Hillcrest Hospital Cancer Center | Mayfield Heights | Ohio | 44124 | — |
| North Coast Cancer Care | Sandusky | Ohio | 44870 | — |
| Cleveland Clinic Cancer Center Strongsville | Strongsville | Ohio | 44136 | — |
| South Pointe Hospital | Warrensville Heights | Ohio | 44122 | — |
| Cleveland Clinic Wooster Family Health and Surgery Center | Wooster | Ohio | 44691 | — |
| Cancer Centers of Southwest Oklahoma Research | Lawton | Oklahoma | 73505 | — |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| Providence Saint Vincent Medical Center | Portland | Oregon | 97225 | — |
| Portland VA Medical Center | Portland | Oregon | 97239 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Saint Francis Hospital | Greenville | South Carolina | 29601 | — |
| Saint Francis Cancer Center | Greenville | South Carolina | 29607 | — |
| Baptist Memorial Hospital and Cancer Center-Memphis | Memphis | Tennessee | 38120 | — |
| Huntsman Cancer Institute/University of Utah | Salt Lake City | Utah | 84112 | — |
| George E Wahlen Department of Veterans Affairs Medical Center | Salt Lake City | Utah | 84148 | — |
| University of Virginia Cancer Center | Charlottesville | Virginia | 22908 | — |
| Inova Schar Cancer Institute | Fairfax | Virginia | 22031 | — |
| VCU Massey Comprehensive Cancer Center | Richmond | Virginia | 23298 | — |
| FHCC Overlake | Bellevue | Washington | 98004 | — |
| FHCC at EvergreenHealth | Kirkland | Washington | 98034 | — |
| FHCC at Northwest Hospital | Seattle | Washington | 98133 | — |
| Vandalia Health/CAMC Institute for Academic Medicine | Charleston | West Virginia | 25304 | — |
| Duluth Clinic Ashland | Ashland | Wisconsin | 54806 | — |
| Marshfield Medical Center-EC Cancer Center | Eau Claire | Wisconsin | 54701 | — |
| Saint Vincent Hospital Cancer Center Green Bay | Green Bay | Wisconsin | 54301 | — |
| Saint Vincent Hospital Cancer Center at Saint Mary's | Green Bay | Wisconsin | 54303 | — |
| Gundersen Lutheran Medical Center | La Crosse | Wisconsin | 54601 | — |
| Marshfield Medical Center-Marshfield | Marshfield | Wisconsin | 54449 | — |
| Marshfield Medical Center - Minocqua | Minocqua | Wisconsin | 54548 | — |
| Saint Vincent Hospital Cancer Center at Oconto Falls | Oconto Falls | Wisconsin | 54154 | — |
| Marshfield Medical Center-Rice Lake | Rice Lake | Wisconsin | 54868 | — |
| Saint Vincent Hospital Cancer Center at Sheboygan | Sheboygan | Wisconsin | 53081 | — |
| Marshfield Medical Center-River Region at Stevens Point | Stevens Point | Wisconsin | 54482 | — |
| Saint Vincent Hospital Cancer Center at Sturgeon Bay | Sturgeon Bay | Wisconsin | 54235-1495 | — |
| Marshfield Medical Center - Weston | Weston | Wisconsin | 54476 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04799275, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 1, 2026 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04799275 live on ClinicalTrials.gov.