Study on Glofitamab and Pirtobrutinib for Treating Relapsed or Resistant Mantle Cell Lymphoma

Sponsor: C. Babis Andreadis

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06252675

Provider View

This clinical trial is exploring the safety and effectiveness of combining two drugs, glofitamab and pirtobrutinib, to treat patients with mantle cell lymphoma that has returned or not responded to previous treatments.

Patient Parameters

Program Overview

This study is testing a new treatment for mantle cell lymphoma, a type of cancer that affects the lymph nodes. The treatment combines two drugs: glofitamab, which helps the immune system target cancer cells, and pirtobrutinib, which blocks signals that help cancer cells grow. The goal is to see if this combination is safe and effective for patients whose cancer has come back or hasn't responded to other treatments.

Description

The main goals of this study are to determine if the combination of glofitamab and pirtobrutinib is safe and to see how well it works in treating mantle cell lymphoma that has returned or is resistant to treatment. Researchers will look at how many patients experience a complete response, meaning no signs of cancer, and how long these responses last. They will also monitor the safety and side effects of the treatment.

Participants will receive the drug obinutuzumab through an IV at the start of the study. Then, they will receive glofitamab through an IV and take pirtobrutinib by mouth in cycles that repeat every 21 days, for up to 12 cycles. During the study, participants will have regular scans and tests to monitor their health and the cancer's response to treatment. After finishing the treatment, participants will have follow-up visits every three months for up to two years.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a life expectancy of at least 12 weeks.
  • Be in good overall health with a performance status score of less than 2.
  • Have mantle cell lymphoma that has returned or not responded to at least one previous treatment.
  • Have at least one measurable tumor.
  • Provide a tissue sample from a previous biopsy.
  • Have adequate blood counts and organ function based on specific tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and after the study.
  • Men must agree to use contraception and not donate sperm during and after the study.
  • Be able to swallow pills.
  • Have no active hepatitis B or C infections, or have these conditions under control.
  • Have recovered from any previous treatment-related side effects to a mild level.

Exclusion Criteria

  • Pregnant or planning to become pregnant during or shortly after the study.
  • Currently breastfeeding.
  • Have had certain treatments or procedures recently, such as major surgery or specific cancer therapies.
  • Have active central nervous system lymphoma or certain other brain conditions.
  • Have another active cancer unless in remission with a good prognosis.
  • Have a history of severe allergic reactions to similar treatments.
  • Have significant heart or lung disease.
  • Have active infections or a history of certain infections.
  • Require ongoing treatment with certain medications that interact with the study drugs.
  • Have a history of bleeding disorders or conditions affecting drug absorption.

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