Actively Recruiting
Sonrotoclax, Rituximab, and Zanubrutinib in Treating Participants With Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, and Mantle Cell Lymphoma
Led by Fred Hutchinson Cancer Center · Updated on 2026-04-22
30
Participants Needed
1
Research Sites
369 weeks
Total Duration
On this page
Sponsors
F
Fred Hutchinson Cancer Center
Lead Sponsor
B
BeOne Medicines
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Sonrotoclax, Rituximab, and Zanubrutinib in Treating Participants With Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, and Mantle Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any study procedures
- Age 18 years or older
- Confirmed diagnosis of CLL/SLL or MCL according to WHO or iwCLL criteria
- For relapsed/refractory patients, disease relapsed after or refractory to at least one prior therapy
- For treatment-nafive patients, no prior treatment except one short aborted regimen over 4 weeks before enrollment
- Measurable disease as defined by lymph node size or clonal lymphocytes in blood
- ECOG performance status 0 to 2
- Adequate blood counts (neutrophils, platelets, hemoglobin) within 7 days before first dose
- Adequate kidney function with creatinine clearance or GFR 60 mL/min
- Liver enzymes and bilirubin within specified limits
- Women of childbearing potential must have negative pregnancy test and use effective contraception during and after study
- Men must use effective contraception and not donate sperm during and after study
- Life expectancy greater than 6 months
- Able to comply with study requirements
You will not qualify if you...
- Use of Bcl-2 inhibitor within last 12 months or disease progression on such therapy
- Other cancers within past 2 years except certain treated skin, bladder, cervical, breast, or prostate cancers
- Medical conditions that increase risk or interfere with study
- Known central nervous system involvement by lymphoma or leukemia
- Certain blood cancers or suspected Richter's syndrome
- Recent stem cell transplant or CAR-T therapy within 3 months
- Active graft-versus-host disease or recent immunosuppressive treatment
- History of severe bleeding disorders
- Recent biologic, chemotherapy, radiation, or corticosteroid treatments within specified timeframes
- Active serious infections requiring treatment
- Recent major surgery within 4 weeks
- Unresolved toxicities from prior therapies
- Significant heart disease or abnormal heart rhythms
- Known HIV or active hepatitis B or C infection unless controlled
- Pregnant or lactating women
- Unable to swallow capsules or significant gastrointestinal disorders
- Inability to follow study procedures
- Recent use of drugs affecting sonrotoclax metabolism
- Unwillingness to avoid certain foods during study
- History of lung diseases or poorly controlled autoimmune anemia or thrombocytopenia
- Ongoing liver diseases or injury
- Use of drugs known to prolong heart QT interval
- Recent live vaccinations within 35 days before study drug start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
M
Mazyar Shadman, MD, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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