Sonrotoclax, Rituximab, and Zanubrutinib in Treating Participants With Chronic Lymphocytic
This phase II trial studies the side effects of an escalated ramp-up of sonrotoclax following initial debulking with zanubrutinib or rituximab in treating patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and mantle cell lymphoma (MCL) that is newly diagnosed, has come back after a per
| Condition(s) | Chronic Lymphocytic Leukemia, Mantle Cell Lymphoma, Recurrent Chronic Lymphocytic Leukemia, Recurrent Mantle Cell Lymphoma, Recurrent Small Lymphocytic Lymphoma, Refractory Chronic Lymphocytic Leukemi |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | This phase II trial studies the side effects of an escalated ramp-up of sonrotoclax following initial debulking with zanubrutinib or rituximab in treating patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and mantle cell lymphoma (MCL) that is newly diagnosed, has come back after a period of improvement (relapsed) or does not respond to treatment (refractory). Rituximab is a monoclonal antibody that binds to a protein called CD20, which is found on B-cells, and may kill tumor cells. Zanubrutinib may stop the growth of tumor cells by blocking a protein called Bruton's tyrosine kinase (BTK), which is needed for tumor cell growth. Sonrotoclax works by blocking a protein called B-cell lymphoma-2 (BCL-2). This protein helps certain types of blood tumor cells to |
| Who can participate | Inclusion Criteria: * Provision of signed and dated written informed consent prior to any study-specific procedures, sampling, or analyses * Age 18 years or older * Confirmed diagnosis (per World Health Organization \[WHO\] guidelines, unless otherwise noted) of one of the following: * CLL/SLL COHORT: CLL/SLL diagnosis that meets the International Workshop on Chronic Lymphocytic Leukemia criteria: * Meeting the following sets of prior treatment criteria: * For the R/R cohort, disease that relapsed after, or was refractory to, at least 1 prior therapy * For the treatment-naïve cohort, patients should have no prior treatment for CLL/SLL (other than 1 aborted regimen \< 2 weeks in duration and \> 4 weeks before enrollment) * Requiring treatment per International Workshop on CLL (iwCLL) criter |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Fred Hutchinson Cancer Center |
| Locations | Seattle, Washington, United States |
| Start date | 2025-06-02 |
| NCT ID | NCT06839053 |
| Official listing | https://clinicaltrials.gov/study/NCT06839053 |