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A Phase-3-trial of Acalabrutinib, Obinutuzumab & Venetoclax Compared to Obinutuzumab and Venetoclax in Previously Untreated Patients With High Risk CLL

StatusRecruiting
PhasePhase 3
Started
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Record History

See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fieldsv8
  2. Enrollment target: 650 to 202
    • Site details revised at 28 of 30 sites
    • Eligibility criteria expanded, about 5 words
    v7
  3. Study Identification, Study Statusv6
  4. Primary completion date: May 2026 to May 2028
    • Study completion date: Feb 2027 to May 2028
    v5
  5. 2 versions Re-verified since Oct 2, 2023, no change to tracked fieldsv3-v4
  6. Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Primary completion date: Apr 2026 to May 2026
    • Study completion date: Jan 2027 to Feb 2027
    • Start date changed from estimate of Feb 2022 to Apr 19, 2022
    • Site details revised at 30 of 30 sites
    • Study title shortened, about 6 words
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This multicenter, prospective, open-label, randomized, superiority phase 3 study is designed to demonstrate that treatment with a triple combination of acalabrutinib, obinutuzumab and venetoclax (GAVe) prolong the progression-free survival (PFS) as compared to treatment with the combination of obinutuzumab and venetoclax (GVe) in pa-tients with high risk CLL (defined as having at least one of the follow-ing risk factors: 17p-deletion, TP53-mutation, complex karyotype or an unmutated IGHV-gene status).
Trial Details
NCT Number NCT05197192
Lead Sponsor German CLL Study Group
Collaborators: AstraZeneca
Conditions
(from sponsor)		 Chronic Lymphocytic Leukemia
Related terms Leukemia, Lymphocytic, Chronic, B-Cell
Enrollment 202 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov