Study Comparing Glofitamab Alone to Other Treatments for Relapsed or Hard-to-Treat Mantle Cell Lymphoma
Sponsor: Hoffmann-La Roche
Sponsor score: 40
Inactive
ClinicalTrials ID:NCT06084936
This clinical trial is testing the effectiveness of the drug glofitamab on its own compared to other treatments chosen by doctors for patients with mantle cell lymphoma that has returned or is not responding to treatment.
Patient Parameters
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Program Overview
The aim of this study is to see how well the drug glofitamab works by itself compared to other treatment options chosen by doctors, such as rituximab with bendamustine or lenalidomide with rituximab, in patients whose mantle cell lymphoma has come back or is not responding to previous treatments.
Eligibility Criteria
Inclusion Criteria
- Expected to live at least 12 more weeks.
- Confirmed diagnosis of mantle cell lymphoma (MCL) with specific genetic markers.
- Cancer has returned after treatment or has not responded to previous treatments.
- Have had at least one previous treatment, including a BTK inhibitor.
- Tumor tissue sample available, unless unsafe to obtain.
- At least one measurable tumor on a CT scan.
- Good overall health with an ECOG performance status of 0, 1, or 2.
- Negative HIV test.
- Adequate blood cell counts and function.
Exclusion Criteria
- Pregnant or breastfeeding, or planning to become pregnant during the study or shortly after.
- Specific type of mantle cell lymphoma that affects the blood but not the lymph nodes.
- Severe allergies to certain antibody treatments.
- Cannot take certain cancer drugs like obinutuzumab, rituximab, bendamustine, or lenalidomide.
- Previously treated with glofitamab or similar drugs.
- Previously received CAR-T cell therapy.
- Recent cancer treatment with certain drugs or experimental treatments.
- Cancer affecting the brain or history of brain-related diseases.
- Other cancers that could interfere with the study.
- Serious heart disease.
- Active infections or recent major infections.
- Tuberculosis or certain viral infections like hepatitis B or C.
- History of specific immune system disorders.
- Recent live vaccine.
- Previous organ or stem cell transplant.
- Eligible for stem cell transplant.
- Active autoimmune disease needing treatment.
- Recent use of immunosuppressive drugs or steroids.
- Recent major surgery.
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