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NCT07734038

Venetoclax Plus Zanubrutinib for the Treatment of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

StatusRecruiting
PhasePhase 2
Primary completion (estimated)
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Record History

All 3 versions: 3 with changes below. See every version on ClinicalTrials.gov ↗

  1. Notable Eligibility criteria expanded, about 55 words
    • Start date changed from estimate of Oct 1, 2026 to Sep 16, 2026
    • Secondary endpoints: details revised at 2 of 13 entries
  2. Notable Recruitment opened
    • Start date: Oct 7, 2026 to Oct 1, 2026
    • Site details revised
    v2
  3. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Rate of undetectable minimal residual disease (uMRD) (Firstline Cohort)
Timeframe: At end of cycle 15 (cycle length = 28 days)
Rate of uMRD (Second Line Cohort)
Timeframe: At end of cycle 27 (cycle length = 28 days)

Secondary (13)

Overall response rate (Frontline Cohort)
Rate of complete remission (Frontline Cohort)
Duration of clinical response (Frontline Cohort)
Duration of uMRD if achieved (Frontline Cohort)
Time to next treatment (Frontline Cohort)
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Rate of adverse events (AEs) (Frontline Cohort)
Overall response rate (Second Line Cohort)
Rate of complete remission (Second Line Cohort)
Rate of uMRD (Second Line Cohort)
Duration of clinical response (Second Line Cohort)
Duration of uMRD if achieved (Second Line Cohort)
Time to next treatment (Second Line Cohort)
Rate of AEs (Second Line Cohort)

Arms and interventions

Cohort I (SOC zanubrutinib, venetoclax)Experimental

Patients receive SOC zanubrutinib PO QD or BID per physician discretion on days 1-28 of each cycle. Starting with cycle 4, patients also receive venetoclax PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for up to 15 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, bone marrow biopsy and aspiration, and CT or MRI throughout the study.

Cohort II (SOC zanubrutinib, venetoclax)Experimental

Patients receive SOC zanubrutinib PO QD or BID per physician discretion on days 1-28 of each cycle. Starting with cycle 4, patients also receive venetoclax PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for up to 27 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, bone marrow biopsy and aspiration, and CT or MRI throughout the study.

Procedures: Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Computed Tomography, Magnetic Resonance Imaging

Drugs: Venetoclax, Zanubrutinib

Sites

1 site in 1 country

  • Ohio State University Comprehensive Cancer CenterColumbus, Ohio, United States