Study on Pirtobrutinib and Mosunetuzumab for Treating Relapsed or Hard-to-Treat Grades 1-3A Follicular Lymphoma
Sponsor: University of Washington
ClinicalTrials ID:NCT06948786
This clinical trial is exploring how well the combination of pirtobrutinib and mosunetuzumab works in patients with follicular lymphoma that has either returned after treatment or hasn't responded to previous therapies.
Patient Parameters
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Program Overview
This study is testing a new treatment approach for patients with grades 1-3A follicular lymphoma that has come back or hasn't responded to other treatments. The trial combines two drugs: pirtobrutinib, which blocks a protein that helps cancer cells grow, and mosunetuzumab, which helps the immune system attack cancer cells. By using these drugs together, researchers hope to kill more cancer cells and reduce some side effects related to immune system activation.
Description
In this study, patients will take pirtobrutinib by mouth every day starting 7 days before they begin receiving mosunetuzumab. They will continue taking pirtobrutinib for up to 52 weeks. Mosunetuzumab will be given through an IV on specific days during the first cycle and then once every 21 days for up to 17 cycles, unless the cancer progresses or side effects become too severe. If patients achieve a complete response after 8 cycles, they will stop receiving mosunetuzumab. Throughout the study, patients will have various tests and procedures, including blood tests, scans, and possibly biopsies, to monitor their health and the treatment's effectiveness. After finishing the treatment, patients will have follow-up visits for up to 4 years.
Eligibility Criteria
Inclusion Criteria
- Must be able to understand and sign a consent form.
- Age 18 or older.
- Good overall health with a performance status of 0 or 1.
- Diagnosed with grades 1-3A follicular lymphoma.
- Cancer has returned or not responded after at least two previous treatments, including anti-CD20 therapy.
- Previous treatment side effects must have improved to mild levels, except for hair loss and mild nerve damage.
- At least one measurable tumor by scan.
- Liver and kidney function within specified limits.
- Adequate blood cell counts.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for a specified time after.
- Men must agree to use effective birth control during the study and for a specified time after.
Exclusion Criteria
- Cancer that did not respond to previous BTK inhibitor treatment within 6 months.
- Previous treatment with pirtobrutinib.
- Recent treatment with certain cancer therapies or radiation.
- Recent stem cell transplant or CAR-T therapy with ongoing complications.
- Cannot swallow pills.
- History of bleeding disorders or major bleeding events.
- Significant digestive issues affecting drug absorption.
- History of autoimmune diseases or certain infections.
- Recent major surgery or active infections.
- Positive for hepatitis B, hepatitis C, or HIV.
- Pregnant or breastfeeding women.
- Recent live vaccination.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | 98109 | Seattle | Washington |
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