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Azacitidine Combined with Donor Lymphocyte Infusion for Acute Myeloid Leukemia Post-transplant Relapse Prevention.

StatusNot Yet Recruiting
PhasePhase 2
Started
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Record History

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  1. Primary endpoint revisedv2 Show 6 more changesShow less
    • Start date: Jan 1, 2025 to Jan 16, 2025
    • Interventions: Azacitidine combined with donor lymphocyte infusion for prevention of recurrenc after haploid hematopoietic stem cell transplantation e… to Azacitidine (AZA) (Drug)
    • Eligibility criteria revised
    • Secondary endpoints: 3 to 5
    • Study description revised
    • Study title shortened, about 3 words
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This study is single-center, single-arm, prospective, Phase II clinical trial with the primary objective of assessing the effectiveness of azacitidine combined with donor lymphocyte infusion (DLI) in the prevention of recurrence after high-risk haploid hematopoietic stem cells of AML. At the screening/baseline period, informed consent is obtained and the inclusion/exclusion criteria are checked. Plan to enroll 51 patients, and collect demographic data, medical history data, vital signs, physical examination and laboratory tests (blood routine; urine routine; liver and kidney function;Immune indicators: T cell subsets, Treg, etc.), pregnancy tests for female patients and other necessary auxiliary inspections.The time to start treatment is from the +90 to +180 days after high-risk AML haploid hematopoietic stem cell transplantation.
Trial Details
NCT Number NCT06754540
Lead Sponsor Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Conditions
(from sponsor)		 Acute Myeloid Leukemia (AML), Relapse
Related terms Leukemia, Myeloid, Acute, Recurrence
Enrollment 51 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov