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Ibrutinib Monotherapy Versus Fixed-duration Venetoclax Plus Obinutuzumab Versus Fixed-duration Ibrutinib Plus Venetoclax in Patients With Previously Untreated Chronic Lymphocytic Leukaemia (CLL)

Study acronym: CLL17
StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Study Identification, Study Status, Oversightv11
  2. Primary and study completion dates: Mar 2027 to Sep 2027
    • Secondary endpoints: 5 to 9
    • Collaborators: 7 to 10
    • Eligibility criteria expanded, about 3 words
    v10
  3. Re-verified, no change to tracked fieldsv9
  4. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 181 of 181 sites
    v8
  5. Study sites: 1 to 181v7
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  1. Start date: Feb 11, 2021 to Mar 1, 2021v6
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Mar 2021 to Feb 11, 2021
    v5
  3. Re-verified, no change to tracked fieldsv4
  4. Start date: Dec 2020 to Mar 2021v3
  5. Collaborators revised (7)v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The aim of this study is to compare the efficacy of continuous ibrutinib monotherapy with fixed-duration venetoclax plus obinutuzumab and fixed-duration ibrutinib plus venetoclax by measuring progression-free survival (PFS) in patients with previously untreated CLL.
Trial Details
NCT Number NCT04608318
Lead Sponsor German CLL Study Group
Collaborators: Stichting Hemato-Oncologie voor Volwassenen Nederland, Nordic CLL Study Group (NCLLSG), Swiss Group for Clinical Cancer Research (SAKK), Cancer Trials Ireland, Gruppo Italiano Malattie EMatologiche dell'Adulto, Grupo Español de Leucemia Linfocítica Crónica (GELLC), The Israeli CLL Study Group (ICLLSG), Janssen Pharmaceutica N.V., Belgium, AbbVie, Hoffmann-La Roche
Conditions
(from sponsor)		 Chronic Lymphoid Leukemia
Related terms Leukemia, B-Cell
Enrollment 897 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov