A Phase II/III Randomized Study of R-MiniCHOP with or Without CC-486 (OralAzacitidine) in Participants Age 75 Years or Older with Newly Diagnosed Diffuse LargeB Cell Lymphoma, Grade IIIB Follicular Lymphoma, Transformed Lymphoma, andHigh-Grade B-Cell Lymphomas with MYC AND BCL2 and/or BCL6 Rearrangements
Study of CC-486 (Oral Azacitidine) Alone or in Combination with Chemo in Participants with Diffuse Large B Cell Lymphoma (DLBCL) (Ages 75+)
Sponsor: NIH
Enrolling: Male and Female Patients
IRB Number: AAAT7641
U.S. Govt. ID: NCT04799275
Contact: Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu
Additional Study Information: This study is being done to answer the following questions: Will patients that are 75 years of age or older who were recently diagnosed with Diffuse Large B Cell Lymphoma (DLBCL) be able to take the study drug CC-486 (oral azacitidine) plus the standard drug therapy that fights cancer cells for at least 4 cycles of therapy (a cycle = 21 days; 4 cycles is 12 weeks): without significantly more side effects than patients taking the standard drug therapy alone? Have longer, shorter, or the same amount of time without the disease getting worse (progression) than patients taking the standard drug therapy alone? Live longer, live the same amount of time, or live a shorter amount of time than patients taking the standard drug therapy alone? We will also compare any side effects that participants may have and participants' well-being when taking the study drugs and for up to three years after starting to take these drugs to treat the cancer. We are doing this study because we want to find out if this approach is better or worse than the usual approach for the DLBCL. The usual approach is defined as care most people get for DLBCL.
Investigator
Jennifer Amengual, MD
Do You Qualify?
Are you 75 years old or older? Yes No
Have you been recently diagnosed with Diffuse Large B Cell Lymphoma (DLBCL), B-cell lymphoma, or follicular lymphoma? Yes No
Are you willing and able to make frequent visits to the clinic for treatment and evaluation? Yes No
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For more information, please contact:
Research Nurse Navigator
cancerclinicaltrials@cumc.columbia.edu
212-342-5162