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Study of Zanubrutinib, Obinutuzumab, and Venetoclax for CLL or SLL

This study is testing a combination of three medications—zanubrutinib, obinutuzumab, and venetoclax—to treat chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL). Researchers want to see how many patients achieve an "undetectable minimum residual disease (MRD)" response, meaning there's no evidence of the disease left, after one year. You might be able to join if you are 18 or older and have been diagnosed with CLL or SLL. For SLL, your blood must show CLL-like cells. The study aims to enroll about 230 participants, but its current status is unclear.

Study design
This is an interventional study with a planned enrollment of 230 participants. It is testing a combination of three drugs: zanubrutinib, obinutuzumab, and venetoclax.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary goal is measured at 1 year, suggesting follow-up for at least that long.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03824483

Study of Zanubrutinib, Obinutuzumab, and Venetoclax in Patients With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL)

Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatment
Memorial Sloan Kettering Cancer Center
~230 participants
Updated 2026-09-03 on ClinicalTrials.gov
What's tested:ZanubrutinibObinutuzumabVenetoclax

At a glance

Recruiting sites
0 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
establish the rate of minimum residual disease (MRD) undetectable response
Measured over 1 year

Conditions

Chronic Lymphocytic Leukemia (CLL)
Small Lymphocytic Leukemia (SLL)

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NCT03824483

Where you'd take part

This study runs at 8 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Massachusetts General Hospital (Data Collection and Specimen Analysis)

    Boston, Massachusettsno site contact published

  • Memorial Sloan Kettering at Basking Ridge

    Basking Ridge, New Jerseyno site contact published

  • Memorial Sloan Kettering Cancer Center

    New York, New Yorkno site contact published

  • Memorial Sloan Kettering Commack

    Commack, New Yorkno site contact published

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jerseyno site contact published

  • Memorial Sloan Kettering Nassau

    Uniondale, New Yorkno site contact published

  • Memorial Sloan Kettering Westchester

    East White Plains, New Yorkno site contact published

  • Northwestern University

    Evanston, Illinoisno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Andrew Zelenetz, MD, PhD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

Ability and willingness to comply with the requirements of the study protocol
Age ≥18 years
Diagnosis of the following histories according to the WHO criteria
For patients with SLL, peripheral blood flow cytometry must be positive with CLL-like cells accounting for at least 1% of circulating WBC.
No prior systemic therapy for disease under study except:
ECOG performance status of 0 to 2
Adequate hematologic parameters unless due to disease under study:
Adequate renal and hepatic function, per laboratory reference range at Screening as follows:
For females of childbearing potential, a negative serum pregnancy test within 7 days of study treatment
For female patients of childbearing potential, agreement to use highly effective form(s) of contraception (i.e., one that results in a low failure rate \[\<1% per year\] when used consistently and correctly) or remain abstinent (refrain from heterosexual intercourse) during the treatment period and to continue its use for 90 days after the last dose of zanubrutinib AND 30 days after the last dose of venetoclax AND for 18 months after the last dose of obinutuzumab (whichever date is later)
For men with a female partner of childbearing potential or a pregnant female partnet: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom during the treatment period and to continue its use for 90 days after the last dose of zanubrutinib AND, 30 days after the last dose of venetoclax AND for 18 months after the last dose of obinutuzumab (whichever date is later)

Exclusion

Known active histological transformation from CLL to an aggressive lymphoma (i.e., Richter"s transformation)
Active malignancy or systemic therapy for another malignancy within 3 years; local/regional therapy with curative intent such as surgical resection or localized radiation within 3 years of treatment is permitted
Other diagnosis of active cancer
Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks prior to Cycle 1, Day 1
Known bleeding diathesis
Prior major surgical procedure within 4 weeks of study, or anticipation of need for a major surgical procedure during the course of the study
Known CNS hemorrhage or stroke within 6 months of the study
History of progressive multifocal leukoencephalopathy (PML)
History of HIV infection
Active hepatitis B (chronic or acute) or hepatitis C infection a. Patients with occult or prior HBV infection (defined as positive total hepatitis B core antibody \[HBcAb\] and negative HBsAg) may be included if HBV DNA is undetectable. These patients must be willing to take appropriate anti-viral prophylaxis as indicated and undergo monthly DNA testing.
Congestive heart failure, New York Heart Association classification III/IV
Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
Receipt of live-virus vaccines within 28 days prior to the initiation of study treatment or need for live-virus vaccines at any time during study treatment
Known condition or other clinical situation that would affect oral absorption
Psychiatric illness/social situations that would interfere with study compliance
Inability to swallow a large number of tablets
Live-virus vaccines given within 28 days prior to the initiation of study treatment
Immunotherapy
Hormone therapy (other than contraceptives, hormone replacement therapy, or megestrol acetate)
Any therapies intended for the treatment of lymphoma/leukemia whether FDA approved or experimental (outside of this study)
Radiation therapy intended to treat MCL or CLL/SLL
Warfarin or warfarin derivatives
Consumption of one or more of the following within 3 days prior to the first dose of study drug:
Prior anti-CD20 monoclonal antibody therapy for non-malignant indication
Obinutuzumab is contraindicated in patients with a known hypersensitivity (IgE-mediated) reaction to obinutuzumab or to any of its excipients
Prior systemic therapy for CLL; prior single site of local radiation for symptomatic disease is permitted
Females who are currently pregnant or breastfeeding
Participation in a separate investigational therapeutic study unless authorized by the investigator

What this trial measures

  • establish the rate of minimum residual disease (MRD) undetectable response1 year

    Patients will have their minimum residual disease (MRD) response classified by bone marrow peripheral blood flow cytometry with a sensitivity of 10-4.