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Venetoclax Plus Azacitidine Versus Intensive Chemotherapy for Fit Patients With Newly Diagnosed NPM1 Mutated AML

Study acronym: VINCENT
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 11 months later Sep 2028 → Sep 2030
See other at-risk trials from Technische Universität Dresden

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary and study completion pushed from Sep 2028 to Sep 2030
    • Collaborators reordered
    v4
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 2023 to Apr 7, 2024
    • Site details revised at 18 of 18 sites
    v3
  3. Minor Secondary endpoints: 13 to 8v2
  4. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 phase II clinical trial evaluates the efficacy and tolerability of the non-intensive treatment with venetoclax and the hypomethylating agent azacitidine as compared to the standard of care chemotherapy plus gemtuzumab ozogamicin in newly diagnosed NPM1 mutated AML patients fit for intensive chemotherapy.
Trial Details
NCT Number NCT05904106
Lead Sponsor Technische Universität Dresden
Collaborators: AbbVie, University Hospital Heidelberg
Conditions
(from sponsor)
Acute Myeloid Leukemia
Related terms Leukemia, Myeloid, Acute, Neoplasm, Residual
Enrollment 146 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov