Study on Brentuximab Vedotin and Bendamustine for Treating Relapsed or Resistant Follicular Lymphoma

Sponsor: Joseph Tuscano

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04587687

Provider View

This clinical trial is testing a combination of two drugs, brentuximab vedotin and bendamustine, to see if they can effectively treat follicular lymphoma that has returned or is not responding to treatment. The study aims to determine the safety and effectiveness of this drug combination.

Patient Parameters

Program Overview

This study is exploring how well the combination of brentuximab vedotin and bendamustine works in treating patients with follicular lymphoma that has either come back after treatment or is not responding to current treatments. Brentuximab vedotin is a targeted therapy that attaches to specific cancer cells and delivers a toxic agent to kill them. Bendamustine is a chemotherapy drug that works by stopping cancer cells from growing and spreading. The trial aims to find out if this combination is safe and effective in reducing cancer.

Description

The main goal of this study is to see how well the combination of brentuximab vedotin and bendamustine works in shrinking tumors in patients with relapsed or resistant follicular lymphoma. Researchers will measure the complete response rate and overall response rate to evaluate the treatment's effectiveness.

Secondary goals include understanding how long the response lasts, how quickly patients respond, and how long patients live without the disease getting worse. The study will also assess overall survival and the safety of the treatment.

Participants will receive brentuximab vedotin through an IV on the first day and bendamustine through an IV on the first and second days of each treatment cycle. Each cycle lasts 21 days, and patients can receive up to 6 cycles if the disease does not progress and side effects are manageable. If patients respond well and tolerate the treatment, they may continue with brentuximab vedotin alone for up to 10 additional cycles.

After completing the treatment, patients will be monitored for 30 days and then every 3 months for 2 years to track their health and any changes in their condition.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with relapsed or resistant follicular lymphoma that is CD30 positive.
  • Cancer must be measurable by scans, with at least one tumor 1.5 cm or larger.
  • Disease must have returned or not responded after at least one previous treatment.
  • General health status must be good, with an ECOG score of 0 to 2.
  • Life expectancy of more than 3 months.
  • Adequate blood cell counts and organ function as determined by specific tests.
  • Women and men must agree to use effective birth control during the study and for 5 months after the last dose.
  • Ability to understand and sign a consent form.
  • HIV-positive patients can participate if they have a stable treatment regimen, no need for preventive antibiotics, a CD4 count above 250, and an undetectable viral load.

Exclusion Criteria

  • Recent chemotherapy or radiation therapy within 2 weeks before starting the study.
  • Use of certain herbal therapies or investigational drugs shortly before the study.
  • Previous treatment with bendamustine that did not work within 6 months.
  • Use of immunosuppressive medications within 14 days before starting the study, with some exceptions.
  • Uncontrolled central nervous system involvement by lymphoma.
  • Severe allergies to study drugs or similar compounds.
  • Significant liver disease or active infections.
  • Recent major surgery or need for surgery during the study.
  • Recent live vaccines or severe infections.
  • Uncontrolled health conditions that could interfere with the study.

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