Testing Oral Azacitidine with Standard Drug Therapy in Patients Aged 75 or Older with Newly Diagnosed Diffuse Large B Cell Lymphoma

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04799275

Provider View

This study is exploring whether adding oral azacitidine to the standard treatment can improve outcomes for patients aged 75 or older with newly diagnosed diffuse large B cell lymphoma. The trial will compare the effects and side effects of the combination treatment against the standard treatment alone.

Patient Parameters

Program Overview

This clinical trial is testing if adding a new drug, oral azacitidine, to the standard treatment can help control diffuse large B cell lymphoma in patients aged 75 or older. The standard treatment, known as R-miniCHOP, includes a combination of drugs that work together to attack cancer cells. Researchers want to see if the addition of oral azacitidine can shrink the cancer, delay its return, or help patients live longer compared to using R-miniCHOP alone.

Description

The main goals of this study are to determine if adding oral azacitidine to the standard treatment (R-miniCHOP) is safe and if it can help patients live longer without the cancer coming back. The study will also look at how well patients tolerate the treatment and if it can be given safely over several cycles.

Participants will be randomly assigned to one of two groups:

  • Group 1: Will receive oral azacitidine along with the standard R-miniCHOP treatment. This includes taking oral azacitidine for 7 days before starting the first cycle and then continuing it for 14 more days. The standard treatment involves receiving rituximab, cyclophosphamide, doxorubicin, and vincristine through an IV on the first day of each cycle, and taking prednisone by mouth for 5 days. This treatment repeats every 21 days for up to 6 cycles.

  • Group 2: Will receive the standard R-miniCHOP treatment alone, following the same schedule as Group 1.

Throughout the study, participants will have regular blood tests and health checks to monitor their response to the treatment and any side effects. After completing the treatment, participants will be followed up periodically for up to 5 years.

Eligibility Criteria

Inclusion Criteria

  • Must be 75 years or older.
  • Diagnosed with diffuse large B cell lymphoma (DLBCL) or certain related types of lymphoma.
  • Must have had imaging tests to confirm the stage of the cancer within 28 days before joining the study.
  • Must have at least one measurable tumor.
  • If HIV-positive, must be on effective treatment with an undetectable viral load.
  • Must be screened for hepatitis B and C, and have controlled or inactive infections.
  • Must not have cancer in the central nervous system.
  • Must not have active inflammatory bowel disease or other conditions affecting the digestive system.
  • Must not have a history of acute leukemia treated with intensive therapy.
  • Must not have received prior chemotherapy or rituximab for the newly diagnosed DLBCL, except for a specific pre-treatment.
  • Must not have received more than a certain amount of doxorubicin or similar drugs in the past.
  • Must not be taking other experimental drugs.
  • Must not have allergies to azacitidine or similar drugs.
  • Must have a good performance status and adequate kidney, liver, and blood function.
  • Men must agree to use contraception during and after the study.
  • Must not have uncontrolled infections or heart disease.
  • Must not have severe nerve damage or other serious illnesses.
  • Must not have another active cancer requiring treatment, except for certain skin cancers or early-stage breast or prostate cancer in remission.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.