Study of Intensity Modulated Total Marrow Irradiation (IM-TMI) in Addition to Fludarabine/Busulfan Conditioning for Allogeneic Transplantation in High Risk AML and Myelodysplastic Syndromes

StatusActive, Not Recruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary completion moved at least 6 months later Apr 2026 → Nov 2026
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Record History

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  1. Primary and study completion pushed from Apr 2026 to Nov 2026 Show 4 more changesShow less
    • Primary endpoints: details revised at 1 of 1 entry
    • Secondary endpoints: details revised at 3 of 3 entries
    • Publications: details revised at 1 of 1 entry
    • Eligibility criteria shortened, about 5 words
  2. Re-verified, no change to tracked fieldsv12
  3. Primary and study completion dates: Apr 24, 2024 to Apr 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v11
  4. Re-verified, no change to tracked fieldsv10
  5. Primary completion date: Apr 24, 2023 to Apr 24, 2024v9
Show 7 earlier versionsHide 7 earlier versions
  1. Re-verified, no change to tracked fieldsv8
  2. Eligibility criteria expanded, about 21 wordsv7
  3. 2 versions Re-verified since Sep 9, 2020, no change to tracked fieldsv5-v6
  4. Study description expanded, about 144 wordsv4
  5. 2 versions Re-verified since May 17, 2017, no change to tracked fieldsv2-v3
  1. 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 study is a Phase II clinical trial. Patients will receive intensity modulated total marrow irradiation (TMI) at a dose of 9 Gy with standard myeloablative fludarabine/ i.v. targeted busulfan (FluBu) conditioning prior to allogeneic hematopoietic stem cell transplant (HSCT).
Trial Details
NCT Number NCT03121014
Lead Sponsor University of Illinois at Chicago
Conditions
(from sponsor)		 Acute Myeloid Leukemia, Myelodysplastic Syndromes
Related terms Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
Enrollment 38 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov