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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

Testing a new oral drug for older lymphoma patients.

Recruiting
75 years and older
All
Phase 2/3

This study is for patients 75 years or older with a type of cancer called diffuse large B cell lymphoma (DLBCL). It tests if adding a new drug, CC-486 (oral azacitidine), to a usual cancer treatment called R-miniCHOP helps patients live longer or feel better. R-miniCHOP is a mix of medicines: rituximab (helps the immune system fight cancer), prednisone (reduces swelling), and three chemotherapy drugs (cyclophosphamide, doxorubicin, vincristine) to stop cancer growth. The study will check if CC-486 makes the treatment too harmful and if it helps patients more than R-miniCHOP alone. Patients will either get R-miniCHOP with CC-486 or just R-miniCHOP. They will receive treatments in cycles every 21 days and be monitored for up to 5 years. Before joining, patients must meet certain health conditions, like having controlled infections and good heart health.

  • The study lasts for several months with follow-ups for up to 5 years.
  • Patients will have regular blood tests and health checks.
  • Potential risks include side effects from the drugs used.
Study details
    Ann Arbor Stage III Diffuse Large B-Cell Lymphoma
    Ann Arbor Stage IIX (Bulky) Diffuse Large B-Cell Lymphoma
    Ann Arbor Stage IV Diffuse Large B-Cell Lymphoma
    Diffuse Large B-Cell Lymphoma Activated B-Cell Type
    Diffuse Large B-Cell Lymphoma Associated With Chronic Inflammation
    Diffuse Large B-Cell Lymphoma Germinal Center B-Cell Type
    Diffuse Large B-Cell Lymphoma
    Not Otherwise Specified
    EBV-Positive Diffuse Large B-Cell Lymphoma
    Not Otherwise Specified
    Grade 3b Follicular Lymphoma
    HHV8-Positive Diffuse Large B-Cell Lymphoma
    Not Otherwise Specified
    High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements
    High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
    High Grade B-Cell Lymphoma With MYC
    BCL2
    and BCL6 Rearrangements
    High Grade B-Cell Lymphoma
    Not Otherwise Specified
    Intravascular Large B-Cell Lymphoma
    Lymphoplasmacytic Lymphoma
    Nodular Lymphocyte Predominant B-Cell Lymphoma
    Primary Cutaneous Diffuse Large B-Cell Lymphoma
    Leg Type
    T-Cell/Histiocyte-Rich Large B-Cell Lymphoma
    Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma
    Transformed Marginal Zone Lymphoma to Diffuse Large B-Cell Lymphoma

NCT04799275

National Cancer Institute (NCI)

16 March 2025

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