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

Contact:

NCT Number:

Protocol:

AAAT7641

Study Status:

Active/Enrolling

Population:

Adult

Phase:

II/III

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.

Are you Eligible? (Inclusion Criteria)

  • Are you 75 years old or older?
  • Have you been recently diagnosed with Diffuse Large B Cell Lymphoma, B-cell
  • lymphoma, or follicular lymphoma?
  • Are you willing and able to make frequent visits to the clinic for treatment and
  • evaluation?

Specialty Area(s)

Lymphoma, Non-Hodgkin's Lymphoma, Immunotherapy

Principal Investigator

Trial Location(s)

CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032