Actively Recruiting
Zanubrutinib, Obinutuzumab, and Sonrotoclax in Previously Untreated Patients With CLL or SLL
Led by Massachusetts General Hospital · Updated on 2025-09-25
40
Participants Needed
2
Research Sites
250 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
B
BeOne Medicines
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to determine the proportion of participants who achieve undetectable measurable residual disease (uMRD) in previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
CONDITIONS
Official Title
Zanubrutinib, Obinutuzumab, and Sonrotoclax in Previously Untreated Patients With CLL or SLL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) according to WHO criteria
- Requires treatment based on iwCLL guidelines
- No prior systemic therapy for CLL or SLL except prior local radiation for symptomatic disease or short courses of systemic corticosteroids (≤14 days, specific dose limits) discontinued before study treatment
- Age 18 years or older
- ECOG performance status of 0, 1, or 2
- Adequate organ and marrow function as defined by specific blood counts and organ function tests
- Negative serum pregnancy test for females of childbearing potential during screening
- Agreement to use highly effective contraception or sexual abstinence during treatment and for specified periods after last doses of study drugs
- Willingness to avoid sperm or oocyte donation during treatment and specified follow-up periods
- Ability to understand and sign informed consent
You will not qualify if you...
- Known transformation from CLL or SLL to aggressive lymphoma (Richter's transformation)
- Central nervous system involvement with CLL or SLL
- Active malignancy or systemic therapy for another cancer within 2 years, except for certain localized treatments
- Uncontrolled illness that would prevent study therapy, including significant infections, heart conditions, pulmonary disease, or autoimmune dysfunction
- Congestive heart failure NYHA class III/IV or recent unstable angina or myocardial infarction
- History of serious arrhythmias or certain heart conduction abnormalities without pacemaker
- Receipt of live-virus vaccine within 28 days before treatment or need for such vaccine during treatment
- Active infections excluding nail fungal infections
- Known bleeding disorders or history of severe bleeding
- Major surgery within 4 weeks before study or planned major surgery during study
- Recent CNS hemorrhage or stroke within 6 months
- History of progressive multifocal leukoencephalopathy
- HIV infection or active hepatitis B or C infection, with specific criteria for controlled HIV and hepatitis
- Conditions preventing swallowing or absorption of oral medications
- Participation in other investigational therapeutic trials without authorization
- Use of certain CYP3A inhibitors or inducers, warfarin, or dual antiplatelet therapy
- Prior anti-CD20 monoclonal antibody therapy
- Hypersensitivity to study drugs or their components
- Consumption of grapefruit, Seville oranges, or star fruit within 3 days before treatment
- Psychiatric or social conditions interfering with adherence
- Pregnancy or breastfeeding
- Uncontrolled autoimmune anemia or thrombocytopenia requiring ongoing corticosteroids
- Need for ongoing corticosteroid treatment
- Uncontrolled hypertension defined by specific blood pressure thresholds
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
2
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Not Yet Recruiting
Research Team
J
Jacob Soumerai, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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