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Testing CC-486 (Oral Azacitidine) Plus the Standard Drug Therapy in Patients 75 Years or Older With Newly Diagnosed Diffuse Large B Cell Lymphoma

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 (S1918)
Therapeutic Area Diffuse Large B-Cell Lymphoma
Principal Investigator Yun Choi, MD
Min Age 75 Years
Gender Any
Contact Sarah Sexton
More Information


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. It 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 Details

Inclusion Criteria

1. Participants must have histologically or cytologically confirmed diffuse large B-cell lymphoma (DLBCL), Ann Arbor Stage IIX (bulky), III or IV.

2. Participants must have staging imaging performed within 28 days prior to registration,

3. Participants must have a Zubrod performance status of 0-2

Exclusion Criteria

1. Participants must not have known lymphomatous involvement of the central nervous system (CNS)

2. 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

3. 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

Study Requirements

This trial is a Phase II/III evaluation of CC-486 (oral azacitidine) added to R-mini-CHOP. 
The trial will include two integrated geriatric assessment tools that will support clinical decision-making in this population: 
a) The FIL (Fondazione Italiana Linfomi) tool will be used to assign patients into fit, unfit, frail, and superfrail categories; and 
b) The Alliance Cancer and Aging Research Group (CARG) Comprehensive Geriatric Assessment tool, now known as the S1918 CGA, will provide serial measurements capturing multiple facets of daily functioning.