Actively Recruiting
Study of Zanubrutinib, Obinutuzumab, and Venetoclax in Patients With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL)
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-05-07
230
Participants Needed
8
Research Sites
414 weeks
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
R
Roche-Genentech
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to determine the rate of minimum residual disease (MRD) negative response (i.e. the rate of no evidence of disease) of the study drugs, zanubrutinib, obinutuzumab, and venetoclax, given in combination as a treatment for CLL and/or SLL.
CONDITIONS
Official Title
Study of Zanubrutinib, Obinutuzumab, and Venetoclax in Patients With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed, informed consent
- Ability and willingness to comply with study requirements
- Age 18 years or older
- Diagnosis of CLL, SLL, or mantle cell lymphoma (MCL) per WHO criteria
- For SLL, peripheral blood flow cytometry positive with CLL-like cells ≥1% of circulating WBC
- No prior systemic therapy for disease studied except prior local radiation or short course corticosteroids (≤14 days, low dose)
- ECOG performance status 0 to 2
- Adequate hematologic parameters unless due to disease
- Adequate renal and hepatic function per laboratory reference ranges
- Negative pregnancy test for females of childbearing potential within 7 days of treatment
- Agreement to use highly effective contraception or abstain during treatment and specified follow-up periods
- Additional criteria for CLL cohort: requires treatment per IWCLL guidelines
- Additional criteria for TP53 mutant MCL cohort: untreated stage II-IV MCL with TP53 mutation or p53 overexpression
- Additional criteria for transplant ineligible MCL cohort: untreated stage II-IV MCL, age ≥65 or ineligible for high dose therapy/autologous stem cell transplant due to comorbidities
You will not qualify if you...
- Known active transformation from CLL to aggressive lymphoma (Richter's transformation)
- Active malignancy or systemic therapy for another cancer within 3 years except localized curative treatments
- Uncontrolled illnesses precluding study therapy (e.g., active infections, severe heart or lung disease)
- Active infections requiring IV antibiotics or hospitalization within 4 weeks prior to treatment
- Known bleeding disorders
- Major surgery within 4 weeks prior to study or planned during study
- CNS hemorrhage or stroke within 6 months
- History of progressive multifocal leukoencephalopathy (PML)
- History of HIV infection unless well controlled with undetectable viral load and sufficient CD4 count
- Active hepatitis B or C infections unless appropriately managed
- Severe congestive heart failure (NYHA class III/IV)
- Significant liver disease or current alcohol abuse
- Receipt of live-virus vaccines within 28 days prior to treatment or planned during study
- Conditions affecting oral drug absorption
- Psychiatric or social issues interfering with study compliance
- Inability to swallow large number of tablets
- Use of strong/moderate CYP enzyme inhibitors or inducers within 7 days prior to first dose
- Prior anti-CD20 therapy for non-malignant indication
- Known hypersensitivity to obinutuzumab or its excipients
- Females who are pregnant or breastfeeding
- Participation in another investigational therapeutic study unless authorized
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Northwestern University
Evanston, Illinois, United States, 60208
Actively Recruiting
2
Massachusetts General Hospital (Data Collection and Specimen Analysis)
Boston, Massachusetts, United States, 02114
Actively Recruiting
3
Memorial Sloan Kettering at Basking Ridge
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
4
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States, 07748
Actively Recruiting
5
Memorial Sloan Kettering Commack
Commack, New York, United States, 11725
Actively Recruiting
6
Memorial Sloan Kettering Westchester
Harrison, New York, United States, 10604
Actively Recruiting
7
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
8
Memorial Sloan Kettering Nassau
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
A
Andrew Zelenetz, MD, PhD
CONTACT
A
Anthony Mato, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here