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Evaluation of DASATINIB Monotherapy Efficacy in Acute Myeloid Leukemia Patients Refractory to VENETOCLAX-AZACITIDINE

Study acronym: VEN-R DASA
StatusSuspended
PhasePhase 2
Started
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Record History

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  1. Recruitment suspended Sponsor's reason: Planned interim analyse Show 4 more changesShow less
    • Primary completion pushed from Jul 8, 2026 to Jan 2027
    • Study completion pushed from Oct 31, 2027 to Jan 2029
    • Eligibility criteria expanded, about 18 words
    • Site details revised
  2. Primary completion date: Oct 31, 2025 to Jul 8, 2026v7
  3. Site contact updatedv6
  4. Study completion date: Oct 31, 2025 to Oct 31, 2027v5
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 31, 2023 to May 22, 2024
    • Study sites: 0 to 1
    • Study arms: 0 to 1
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 1 of 6 entries
    v3
  2. Start date: Oct 31, 2023 to Dec 31, 2023v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 goal of this clinical trial is to learn about the efficacy of DASATINIB monotherapy in acute myeloid leukemia patients refractory to VENETOCLAX-AZACITIDINE. The main question it aims to answer is to assess the tumor response after 2 cycles of DASATINIB monotherapy treatment for patients with chemotherapy-ineligible acute myeloid leukemia refractory to VENETOCLAX-AZACITIDINE therapy. Participants will be given DASATINIB treatment up to 3 months. Response will be assessed by a myelogram and a complete blood count at the end of every cycle. Follow up will last 6 months.
Trial Details
NCT Number NCT06055621
Lead Sponsor Institut Paoli-Calmettes
Conditions
(from sponsor)		 Acute Myeloid Leukemia
Related terms Leukemia, Myeloid, Acute
Enrollment 35 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov