Venetoclax + Azacitidine in Patients With Acute Myeloid Leukemia

Study acronym: VERDI
StatusActive, Not Recruiting
PhasePhase 2
Started

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Record History

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  1. Enrollment closed, study ongoing Show 5 more changesShow less
    • Enrollment target: estimated 29 to confirmed 28
    • Eligibility criteria expanded, about 32 words
    • Secondary endpoints: details revised at 1 of 4 entries
    • Study description revised
    • Site details revised at 14 of 14 sites
  2. Eligibility criteria expanded, about 18 words
    • Site contacts updated at 1 of 14 sites
    v4
  3. Site details revised at 14 of 14 sitesv3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 2024 to Dec 16, 2024
    • Site details revised at 14 of 14 sites
    v2
  5. Study First Submitted
  • 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 VERDI study is an investigator-initiated, multicenter, multicohort, phase II trial with combination of venetoclax + azacitidine for patients treated for AML under according to an intensive chemotherapy protocol (CETLAM-20) failing to achieve or maintain MRD negativity at pre-established time-points: at chemotherapy completion for ELN favorable subtypes, and prior to alloHCT for non-favorable European LeukemiaNet (ELN) AML patients. The primary objective is to determine Ven/Aza treatment activity in MRD clearance in patients diagnosed with AML with persistent MRD or MRD reappearance after frontline chemotherapy, or prior to alloHCT.
Trial Details
NCT Number NCT06668558
Lead Sponsor Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias
Conditions
(from sponsor)		 Acute Myeloid Leukemia
Related terms Leukemia, Myeloid, Acute, Neoplasm, Residual
Enrollment 28 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov