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

Conditions

• 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

Eligibility Criteria

Sex

ALL

Age

75 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Computed Tomography — PROCEDURE
  Undergo PET-CT
• Cyclophosphamide — DRUG
  Given IV
• Doxorubicin Hydrochloride — DRUG
  Given IV
• Echocardiography Test — PROCEDURE
  Undergo ECHO
• Multigated Acquisition Scan — PROCEDURE
  Undergo MUGA
• Oral Azacitidine — DRUG
  Given PO
• Positron Emission Tomography — PROCEDURE
  Undergo PET-CT
• Prednisone — DRUG
  Given PO
• Questionnaire Administration — OTHER
  Ancillary studies
• Rituximab — BIOLOGICAL
  Given IV
• Rituximab and Hyaluronidase Human — BIOLOGICAL
  Given SC
• Vincristine Sulfate — DRUG
  Given IV

Study Details

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.

Key Dates

Start date

May 20, 2021

Status verified

Apr 2026

Primary completion

Mar 1, 2027

Completion

Mar 1, 2027

Study Design

Enrollment

422 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (oral azacitidine, R-miniCHOP)
  Patients receive CC-486 PO for 7 days prior to cycle 1. Patients then receive CC-486 PO on days 8-21. Treatment repeats every 21 days for cycles 1-5 in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab IV (or rituximab and hyaluronidase human SC for cycles 2-6), cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 1, and prednisone PO on days 1-5. Treatment repeats every 21 days for cycles 1-6 (6 cycles total) in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA at screening and undergo PET-CT and blood sample collection throughout the study.
• Active Comparator: Arm II (R-miniCHOP)
  Patients receive rituximab IV (or rituximab and hyaluronidase human SC for cycles 2-6), cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 1, and prednisone PO on days 1-5. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA at screening and undergo PET-CT and blood sample collection throughout the study.

Primary Outcome Measure

Excess toxicity as a result of adding oral azacitidine (CC-486) to reduced dose rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone (R-miniCHOP) (Safety run-in) [ Time Frame: Up to completion of cycle 6 ]

Locations (176)

Find similar trials in Tucson, AZ

Related Studies

• Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders
  PHASE2 · Recruiting · Masonic Cancer Center, University of Minnesota · Minneapolis, Minnesota
• Ascorbic Acid and Chemotherapy for the Treatment of Relapsed or Refractory Lymphoma, CCUS, and Chronic Myelomonocytic Leukemia
  PHASE2 · Recruiting · Mayo Clinic · Mankato, Minnesota
• A Study of Daratumumab and Dose-Adjusted EPOCH in Plasmablastic Lymphoma
  EARLY_PHASE1 · Recruiting · AIDS Malignancy Consortium · Miami, Florida
• Donor Stem Cell Transplant With Treosulfan, Fludarabine, and Total-Body Irradiation for the Treatment of Hematological Malignancies
  PHASE2 · Recruiting · Fred Hutchinson Cancer Center · Seattle, Washington