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

Complete 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
Trial Phase: II/III
Investigator: Paul Martin

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

Keywords:
  • Lymphoma, Hodgkin
  • Prostate Cancer, Castration-resistant (CRPC)
  • Lymphoma, Follicular
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Adult
II/III
Paul Martin
RG1122020
NCT04799275
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
Lymphoma, Hodgkin
Prostate Cancer, Castration-resistant (CRPC)
Lymphoma, Follicular