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Sonrotoclax, Rituximab, and Zanubrutinib in Treating Participants With Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, and Mantle Cell Lymphoma

StatusRecruiting
PhasePhase 2
Started2025-06-02
View on ClinicalTrials.gov ↗

Amendment history

2026-04-17
Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Eligibility v6
Enrollment target20→30
Eligibility criteria+205 characters
[...] ody therapy, e.g., rituximab, and/or cancer vaccine therapy). If biological and/or immunologic-based therapy(ies) are used for non-oncological indications, enrollment will be at the discretion of the principal investigator (PI) =< 14 days before the first dose of the study drug: Systemic [...] cleic acid (DNA) is undetectable and if they are willing to take HBV reactivation prophylaxis and undergo monitoring for HBV reactivation Presence of HCV anti [...]
Study description+13 characters
[...] x PO QD through cycle 13. Patients also continue to receive ritiximabrituximab PO QD on day 1 of cycles 3-6. Cycles repeat every 28 in the [...] tion of study treatment, patients are followed up at 14 days, at 1 month, and up to 5 years.
2025-11-17
Study Status, Sponsor/Collaborators v5
Collaborators1 entry, revised
BeiGeneBeOne Medicines
2025-06-02
Study Status v4
Start dateestimated 2025-07-01→confirmed 2025-06-02
2025-05-27
Study Identification, Study Status, Eligibility v3
Start date2025-06-01→2025-07-01
Eligibility criteria+488 characters
Inclusion Criteria: Provision of signed and dated written informed consent prior to any study-specific procedures, sampling, or analyses Age 18 years or o [...] Meeting the following sets of prior treatment criteria: For the R/R cohort, disease that relapsed after, or was refractory [...] ) criteria MCL COHORT: WHO-defined MCL R/R MCL is defined as a disease that relapsed after, or was refractory to, at least [...] low cytometry MCL, or SLL: at least 1 lymph node > 1.5 cm in the longest diameter OR 1 extranodal lesion > 1.0 cm in the lon [...] ute neutrophil count (ANC) >= 1.0 x 10^9/L =< 7 days before the first dose o [...] [...]
2025-04-23
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start date2025-07-01→2025-06-01
Study sitesdetails revised at 1 of 1 site
2025-04-09
Study Status v1
Re-verified, no change to tracked fields
2025-02-19
Original filing
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.
Trial Details
NCT Number NCT06839053
Lead Sponsor Fred Hutchinson Cancer Center
Collaborators: BeOne Medicines
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 +1 more
Enrollment 30 participants
Start Date 2025-06-02
Primary Completion 2028-08-01 (estimated)
Study Completion 2032-07-01 (estimated)
Updated on ClinicalTrials.gov 2026-04-22