Study on Sonrotoclax and Zanubrutinib for Treating Adults with Relapsed or Hard-to-Treat Mantle Cell Lymphoma
Sponsor: BeiGene
ClinicalTrials ID:NCT06742996
This clinical trial is testing a new combination of drugs, sonrotoclax and zanubrutinib, to see if they work better than zanubrutinib alone in treating adults with mantle cell lymphoma that has returned or is difficult to treat. The study will also assess the safety of the new drug combination.
Patient Parameters
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Program Overview
The purpose of this study is to compare the effectiveness and safety of a new drug combination, sonrotoclax plus zanubrutinib, against zanubrutinib plus a placebo in adults with mantle cell lymphoma (MCL) that has come back or is not responding to treatment. Researchers aim to find out if the new combination can better manage the disease.
Eligibility Criteria
Inclusion Criteria
- Confirmed diagnosis of mantle cell lymphoma (MCL) based on specific medical classifications.
- Have received 1 to 5 previous treatments, including therapies that target CD20 proteins on cancer cells.
- The disease has returned or not responded after the last treatment.
- Have at least one tumor that can be measured by scans.
- Be in relatively good health, with a performance status score between 0 and 2.
- Have adequate organ function as determined by medical tests.
Exclusion Criteria
- Have previously been treated with a B-cell lymphoma-2 inhibitor.
- Have previously been treated with certain types of Bruton tyrosine kinase inhibitors (BTKi), unless unable to tolerate them.
- Have had a stem cell transplant or CAR-T cell therapy within the last 3 months.
- Have had an allogeneic stem cell transplant within the last 6 months.
- Have lymphoma that has spread to the central nervous system.
- Have significant heart disease.
- Have had a stroke or brain bleeding within the last 6 months.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama At Birmingham Hospital | 35294-0004 | Birmingham | Alabama |
| Mayo Clinic Phoenix | 85054-4502 | Phoenix | Arizona |
| Yale University, Yale Cancer Center | 06520-8028 | New Haven | Connecticut |
| Memorial Cancer Institute, Memorial Healthcare System | 33026-4119 | Pembroke Pines | Florida |
| Cleveland Clinic Florida | 33331-3609 | Weston | Florida |
| Rush University Medical Center | 60612 | Chicago | Illinois |
| Fort Wayne Medical Oncology and Hematology | 46804 | Fort Wayne | Indiana |
| Mission Cancer and Blood | 50263 | Waukee | Iowa |
| University of Maryland Greenebaum Comprehensive Cancer Center | 21201-1544 | Baltimore | Maryland |
| Dana Farber Cancer Institute Longwood Medical Center | 02215-5418 | Boston | Massachusetts |
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