Decitabine and Venetoclax Treatment as Maintenance Therapy in Patients Post Allograft Stem Cell Transplant

StatusRecruiting
PhasePhase 1/2
Started

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Trial flagged as At Risk
Primary completion moved at least 2 months later Dec 2026 → Mar 2027
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Record History

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  1. Minor Primary completion pushed from Dec 2026 to Mar 2027
    • Study completion pushed from Jul 2027 to Sep 2027
    • Eligibility criteria shortened, about 27 words
    • Secondary endpoints: details revised at 1 of 1 entry
  2. Minor Study sites: 1 to 2v8
  3. Minor Study completion date: Dec 2027 to Jul 2027v7
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jul 2025 to Jul 28, 2025
    • Site details revised
    v6
  5. Notable Start date: Jun 1, 2025 to Jul 2025
    • Eligibility criteria shortened, about 31 words
    v5
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  1. Notable Primary completion date: Dec 27, 2025 to Dec 2026
    • Start date: Apr 1, 2025 to Jun 1, 2025
    • Study completion date: Dec 31, 2026 to Dec 2027
    v4
  2. Notable Primary completion date: Dec 27, 2024 to Dec 27, 2025
    • Start date: Oct 1, 2024 to Apr 1, 2025
    • Study completion date: Dec 31, 2025 to Dec 31, 2026
    v3
  3. Notable Start date: Apr 1, 2024 to Oct 1, 2024v2
  1. Minor 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 goal of this interventional clinical trial is to determine if low doses of gentle chemotherapy after bone marrow transplant may prevent relapse and promote an increase in survival and decrease in side effects in participants with acute myeloid leukemia and myelodysplastic syndromes. The main question it aims to answer is whether or not providing a new, gentler way of administering chemotherapy will help control leftover cancer with minimal side effects. This treatment involves decitabine and venetoclax. Participants will receive standard post-transplant care. Participants will be administered decitabine once per week with normal transplant follow up visits, and then will take a venetoclax pill about 6 to 8 hours later. Participants will meet their study team at the beginning, midway, and at the end of the trial to receive bone marrow testing. Participants will receive treatment until either one year of therapy, relapse, or recurrent dose limiting toxicity (DLT) despite dose reduction.
Trial Details
NCT Number NCT06129734
Lead Sponsor Benjamin Tomlinson
Conditions
(from sponsor)
Myeloid Malignancy, Acute Myeloid Leukemia
Related terms Leukemia, Myeloid, Acute
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov