Study Adding Drugs to Usual Treatment for Large B-Cell Lymphoma That Returned or Did Not Respond to Treatment

Sponsor: SWOG Cancer Research Network

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05890352

Provider View

This clinical trial is testing the safety and effectiveness of adding new drugs, tazemetostat and zanubrutinib, to the usual treatment for patients with large B-cell lymphoma that has returned or did not respond to previous treatments. The study aims to find the best dose and see if these combinations can help shrink the cancer or delay its return.

Patient Parameters

Program Overview

This phase 2 study is exploring whether adding the drugs tazemetostat and zanubrutinib to the standard treatment of tafasitamab and lenalidomide can improve outcomes for patients with large B-cell lymphoma that has come back or not responded to earlier treatments. Tazemetostat and zanubrutinib work by stopping cancer cells from growing and spreading. Tafasitamab is a type of antibody that targets cancer cells, and lenalidomide helps the body produce healthy blood cells while attacking cancer cells. The study will assess if these combinations can reduce cancer size or extend the time without symptoms returning.

Description

The study has two main parts. In the first part, researchers will determine the safest and most effective doses of the drug combinations. In the second part, they will compare how well the new combinations work against the standard treatment.

Primary Goals:

  • Find the best dose of the new drug combinations.
  • Compare how long patients live without the cancer getting worse when treated with the new combinations versus the standard treatment.

Secondary Goals:

  • Measure how well the cancer responds to the treatments.
  • Evaluate the safety and side effects of each treatment.
  • Explore how different genetic profiles of the cancer affect treatment outcomes.

Patient Experience:

  • Participants will receive the study drugs and undergo regular scans to monitor the cancer.
  • Blood samples may be collected for further analysis.
  • Participants will report on their symptoms and quality of life throughout the study.

Study Structure:

  • Part I (Safety Run-In): Patients are assigned to one of two groups to test the safety of the drug combinations.

    • Group 1: Receives tafasitamab, lenalidomide, and tazemetostat.
    • Group 2: Receives tafasitamab, lenalidomide, and zanubrutinib.

  • Part II (Randomized Phase): Patients are randomly assigned to one of three groups.

    • Group 1: Receives tafasitamab, lenalidomide, and tazemetostat.
    • Group 2: Receives tafasitamab and lenalidomide.
    • Group 3: Receives tafasitamab, lenalidomide, and zanubrutinib.

Participants will undergo regular imaging tests and may provide blood samples during the study.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with relapsed or refractory large B-cell lymphoma, including specific subtypes like follicular lymphoma grade 3B or transformed lymphoma.
  • Must have had imaging tests within 28 days before joining the study.
  • Must have a specific type of lymphoma cell origin determined by lab tests.
  • Must have had 1-5 previous treatment regimens for aggressive lymphoma.
  • Must be 18 years or older.
  • Must have a performance status score of 0-3, indicating varying levels of activity.
  • Must have adequate blood cell counts and organ function as determined by specific tests.
  • Must not have active infections like HIV or hepatitis unless well-controlled.
  • Must be able to swallow pills and not have significant digestive issues.
  • Must agree to participate in specimen banking and complete certain questionnaires if able.
  • Must provide informed consent to participate in the study.

Exclusion Criteria

  • Must not have active cancer in the central nervous system.
  • Must not have certain genetic abnormalities or a history of specific types of lymphoma.
  • Must not be eligible for or have declined a stem cell transplant.
  • Must not have had previous treatment with the study drugs.
  • Must not have allergies to the study drugs.
  • Must not be taking certain medications that interact with the study drugs.
  • Must not have other cancers that could interfere with the study.
  • Must not be pregnant or nursing and must agree to use effective contraception if of reproductive potential.

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