A Phase II/III Study of CC-486 (Oral Azacitidine) plus Standard Therapy in Older Patients with Newly Diagnosed Diffuse Large B-Cell Lymphoma

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Full 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 (S1918) (CIRB)

Purpose

There is not an accepted or usual approach to treat patients 75 years of age or older diagnosed with diffuse large B-cell lymphoma (DLBCL). Doctors are seeking effective but less intensive treatment regimens, with fewer side effects, for these patients. A standard treatment for DLBCL is R-CHOP (a combination of the drugs rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone).

In this study, researchers are evaluating the effectiveness and side effects of azacitidine, taken orally (by mouth), given in combination with a reduced dose of standard R-CHOP chemotherapy (“R-mini-CHOP”) in patients age 75 and older who are newly diagnosed with DLBCL. Patients in this study will be randomly assigned to receive R-mini-CHOP with or without oral azacitidine.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must be age 75 and older and have stage II-IV DLBCL that has not yet been treated,
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.

For more information about this study and to inquire about eligibility, please contact Dr. Colette Owens at 848-225-6112.

Protocol

21-210

Phase

II/III

Disease Status

Newly Diagnosed

Investigator

Co-Investigators