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Combination Salvage Therapy With Venetoclax and Decitabine in Relapsed/Refractory AML

Study acronym: VenSwitch
StatusRecruiting
PhasePhase 2
Started
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Record status
This record was last updated April 8, 2025 (before its estimated September 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: Dec 4, 2024 to Sep 1, 2026
    • Study completion date: Mar 4, 2025 to Mar 2027
    • Eligibility criteria expanded, about 98 words
    • Secondary endpoints: 9 to 11
    v2
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 prospective, phase II single center, one arm, open label clinical trial is to test the efficacy and feasibility of a combination salvage therapy with Venetoclax and intensified Decitabine in patients with newly diagnosed AML (acute myeloid leukemia) and primary induction failure and patients with relapse of AML/MDS IB2 (myelodysplastic neoplasm with increased blasts 2) after chemotherapy. The primary endpoint is hematologic remission after treatment with Decitabine and Venetoclax. Participants eligible for the trial will receive a treatment of ten days of Decitabine and twenty-eight days of Venetoclax for one or two cycles, after which hematological remission will be assessed. Follow up will include the first one hundred days after end of treatment.
Trial Details
NCT Number NCT06156579
Lead Sponsor University Hospital Tuebingen
Conditions
(from sponsor)		 AML, MDS
Enrollment 27 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov