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

Summary

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.

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

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Computed Tomography

Undergo PET-CT

DRUG

Cyclophosphamide

Given IV

DRUG

Doxorubicin Hydrochloride

Given IV

PROCEDURE

Echocardiography Test

Undergo ECHO

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA

DRUG

Oral Azacitidine

Given PO

PROCEDURE

Positron Emission Tomography

Undergo PET-CT

DRUG

Prednisone

Given PO

OTHER

Questionnaire Administration

Ancillary studies

BIOLOGICAL

Rituximab

Given IV

BIOLOGICAL

Rituximab and Hyaluronidase Human

Given SC

DRUG

Vincristine Sulfate

Given IV

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Elizabeth A Brem · SWOG Cancer Research Network

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-05-20

Primary Completion

2027-03-01

Completion

2027-03-01

FDA Drug

Yes

Countries

• United States

Study Locations