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Sonrotoclax, Rituximab, and Zanubrutinib in Treating Participants With Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, and Mantle Cell Lymphoma
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 survive and grow. When sonrotoclax blocks Bcl-2 it slows down or stops the growth of tumor cells and helps them die. Giving an increased dose of sonrotoclax over a shorter period of time in combination with zanubrutinib or rituximab may be safe and tolerable in treating patients with newly diagnosed, relapsed or refractory CLL, SLL, and MCL.
Details
| Lead sponsor | Fred Hutchinson Cancer Center |
|---|---|
| Phase | PHASE2 |
| Status | RECRUITING |
| Enrolment | 20 |
| Start date | Mon Jun 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Thu Jul 01 2032 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Chronic Lymphocytic Leukemia
- Mantle Cell Lymphoma
- Recurrent Chronic Lymphocytic Leukemia
- Recurrent Mantle Cell Lymphoma
- Recurrent Small Lymphocytic Lymphoma
- Refractory Chronic Lymphocytic Leukemia
- Refractory Mantle Cell Lymphoma
- Refractory Small Lymphocytic Lymphoma
- Small Lymphocytic Lymphoma
Interventions
- Biospecimen Collection
- Bone Marrow Biopsy
- Computed Tomography
- Gastrointestinal Endoscopy
- Rituximab
- Sonrotoclax
- Zanubrutinib
Countries
United States