Study on Tafasitamab, Lenalidomide, and Venetoclax for Treating Mantle Cell Lymphoma That Has Returned or Not Responded to Treatment

Sponsor: Academic and Community Cancer Research United

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05910801

Provider View

This clinical trial is exploring a combination of three drugs—tafasitamab, lenalidomide, and venetoclax—to see how well they work together in treating mantle cell lymphoma that has come back or not responded to previous treatments.

Patient Parameters

Program Overview

This study is testing a combination of three drugs—tafasitamab, lenalidomide, and venetoclax—to see if they can effectively treat mantle cell lymphoma that has returned after treatment or not responded to previous therapies. Tafasitamab is a type of medication that may stop cancer cells from growing and spreading. Lenalidomide helps the immune system attack cancer cells, and venetoclax may block a protein that cancer cells need to survive. By using these drugs together, researchers hope to find a more effective treatment for patients with this type of lymphoma.

Description

The main goal of this study is to see how well the combination of tafasitamab, lenalidomide, and venetoclax works in treating patients with mantle cell lymphoma that has returned or not responded to previous treatments. Researchers will look at how many patients respond to the treatment, how long the response lasts, and how long patients live without the disease getting worse. They will also evaluate the safety of the drug combination.

Patients in the study will receive tafasitamab through an IV, and lenalidomide and venetoclax as pills. They may need to undergo various tests, including scans and blood tests, to monitor their health and the treatment's effects. After completing the treatment, patients will have follow-up visits every few months for up to five years to check on their health and any long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of mantle cell lymphoma with specific genetic markers.
  • The lymphoma must have returned or not responded to at least one previous treatment.
  • Must have a need for treatment due to symptoms or low blood counts.
  • Have at least one measurable tumor or other signs of the disease.
  • Be in good overall health with a performance status score of 0, 1, or 2.
  • Have adequate blood cell counts and organ function as determined by specific tests.
  • Women of childbearing potential must have a negative pregnancy test before starting the study and agree to use effective birth control during and after the study.
  • Men must agree to use condoms during and after the study.
  • Must be willing to participate in a specific safety program for lenalidomide.
  • Must be able to take low-dose aspirin or another blood thinner.
  • Must agree to provide blood samples for research purposes.
  • Must be willing to return for follow-up visits during the study.

Exclusion Criteria

  • Pregnant or breastfeeding women.
  • Men or women who are not willing to use effective birth control during and after the study.
  • Have had a stem cell transplant or certain other treatments within a specific time before starting the study.
  • Have cancer that has spread to the brain or spinal cord.
  • Are currently receiving other treatments for mantle cell lymphoma, except for certain steroids.
  • Have certain medical conditions or are taking medications that could interfere with the study.
  • Have active infections or other serious health issues that could affect participation.
  • Have had a recent heart attack, stroke, or major surgery.
  • Have another active cancer that requires treatment or affects life expectancy.
  • Are unable to swallow pills.

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