OncoMatch/Clinical Trials/NCT03824483
Study of Zanubrutinib, Obinutuzumab, and Venetoclax in Patients With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL)
Is NCT03824483 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Zanubrutinib and Obinutuzumab for chronic lymphocytic leukemia (cll).
Treatment: Zanubrutinib · Obinutuzumab · Venetoclax — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Chronic Lymphocytic Leukemia
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: TP53 mutation
Required: TP53 overexpression (strong nuclear staining of >30% positive nuclei)
Disease stage
Required: Stage II, III, IV
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: systemic therapy
Exception: prior local radiation for symptomatic disease is permitted; short course systemic corticosteroids is permissible for disease control, improvement of performance status or non-cancer indication (must be ≤ 14 days and < 100 mg/day prednisone or ≤ 20 mg/day dexamethasone); inhaled/topical/replacement/stress corticosteroids and low-dose steroids for ITP up to prednisone 20mg/daily at eligibility review are permitted
No prior systemic therapy for disease under study except: prior local radiation for symptomatic disease is permitted; short course systemic corticosteroids is permissible for disease control, improvement of performance status or non-cancer indication (must be ≤ 14 days and < 100 mg/day prednisone or ≤ 20 mg/day dexamethasone). Steroids must be discontinued prior to study treatment. Inhaled steroids for asthma, topical steroids, and replacement/Stress corticosteroids are permitted. Low-dose steroids for ITP are also permitted up to the equivalent prednisone 20mg/daily at time of eligibility review.
Cannot have received: anti-CD20 monoclonal antibody
Exception: for non-malignant indication
Prior anti-CD20 monoclonal antibody therapy for non-malignant indication
Cannot have received: systemic therapy
Exception: prior single site of local radiation for symptomatic disease is permitted
No prior systemic therapy for CLL; prior single site of local radiation for symptomatic disease is permitted
Cannot have received: obinutuzumab (obinutuzumab)
Exception: known hypersensitivity (IgE-mediated) reaction to obinutuzumab or to any of its excipients
Obinutuzumab is contraindicated in patients with a known hypersensitivity (IgE-mediated) reaction to obinutuzumab or to any of its excipients
Lab requirements
Blood counts
ANC ≥1.0 x 10^9/L unless neutropenia is clearly due to disease under study; Platelet count ≥ 75,000/mm3 OR ≥ 20,000/mm3 if thrombocytopenia is clearly due to disease under study; Hemoglobin ≥9.0 g/dL unless anemia is clearly due to marrow involvement due to disease under study
Kidney function
Creatinine clearance of eGFR>30 mL/min according to the Cockcroft-Gault Equation
Liver function
AST/SGOT, ALT/SGPT ≤2.0 x ULN; Total bilirubin ≤ 2.0 x ULN unless secondary to Gilbert's syndrome (≤3 x ULN) or due to disease under study (per PI or Co-PI discretion)
Adequate hematologic parameters unless due to disease under study: ANC ≥1.0 x 10^9/L unless neutropenia is clearly due to disease under study (per investigator discretion); Platelet count ≥ 75,000/mm3 - OR - Platelet count ≥ 20,000/mm3 if thrombocytopenia is clearly due to disease under study (per investigator discretion); Hemoglobin ≥9.0 g/dL unless anemia is clearly due to marrow involvement due to disease under study (per investigator discretion) Adequate renal and hepatic function, per laboratory reference range at Screening as follows: a. AST/SGOT, ALT/SGPT ≤2.0 x ULN b. Total bilirubin ≤ 2.0 x ULN unless: i. Considered secondary to Gilbert's syndrome, in which case ≤3 x ULN ii. Considered due to disease under study (Per PI or Co-PI discretion) c. Creatinine clearance of eGFR>30 mL/min according to the Cockcroft-Gault Equation
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Northwestern University · Evanston, Illinois
- Massachusetts General Hospital (Data Collection and Specimen Analysis) · Boston, Massachusetts
- Memorial Sloan Kettering at Basking Ridge · Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth · Middletown, New Jersey
- Memorial Sloan Kettering Commack · Commack, New York
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