Study on Glofitamab, Ibrutinib, and Obinutuzumab for Treating Mantle Cell Lymphoma

Sponsor: OHSU Knight Cancer Institute

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06357676

Provider View

This clinical trial is testing a new combination of drugs—glofitamab, ibrutinib, and obinutuzumab—to see if they are safe and effective in treating patients with mantle cell lymphoma (MCL), a type of blood cancer.

Patient Parameters

Program Overview

The study aims to evaluate the safety and effectiveness of a new treatment combination for mantle cell lymphoma (MCL), which includes glofitamab, ibrutinib, and obinutuzumab. Glofitamab is a type of protein that helps the immune system target and kill cancer cells. Ibrutinib works by blocking signals that tell cancer cells to grow, and obinutuzumab is another protein that may help stop cancer cells from spreading. This combination may offer a new treatment option for patients with MCL.

Description

The main goals of this study are to determine if the combination of glofitamab and ibrutinib is safe and effective for patients with mantle cell lymphoma (MCL), especially those who are at high risk or are 65 years or older. The study will also look at how well patients respond to the treatment and how long they remain free of disease after treatment.

Participants will take ibrutinib by mouth daily for 21 days in each cycle, up to 17 cycles. Glofitamab will be given through an IV on specific days of the treatment cycles, up to 12 cycles. Obinutuzumab will be given through an IV before the first dose of glofitamab. Patients will also undergo various tests, including heart scans, bone marrow biopsies, and imaging scans, to monitor their health and the treatment's effects.

After completing the study treatments, patients will have follow-up visits every three months for up to two years to check on their health and any signs of cancer returning.

Eligibility Criteria

Inclusion Criteria

  • Must understand the study and provide consent to participate.
  • Diagnosed with mantle cell lymphoma (MCL) with specific genetic markers.
  • Aged 18-64 with certain high-risk features or aged 65 and older without needing high-risk features.
  • No previous treatments for MCL.
  • Must have measurable cancer that can be tracked with scans.
  • Able to provide tissue samples for testing.
  • Good overall health with specific blood counts and organ function.
  • Negative tests for hepatitis B, hepatitis C, HIV, and COVID-19.
  • Willing to follow all study procedures and use contraception if of childbearing potential or producing viable sperm.

Exclusion Criteria

  • Previous treatment for MCL, except for certain steroids.
  • Significant heart disease or recent heart attack.
  • History of other cancers, unless treated and inactive for over two years.
  • Use of certain medications or treatments that could interfere with the study.
  • Known allergies to study drugs or similar medications.
  • History of certain neurological or autoimmune diseases.
  • Recent serious infections or need for live vaccines.
  • Any condition that could compromise safety or study results.

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