Gamma Delta T-cell Infusion for AML at High Risk of Relapse After Allo HCT

StatusActive, Not Recruiting
PhasePhase 1
Started

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Record History

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  1. Study completion pushed from Sep 2026 to Sep 2027
    • Eligibility criteria expanded, about 17 words
  2. Re-verified, no change to tracked fieldsv18
  3. Primary completion date changed from estimate of Sep 2025 to Aug 30, 2025v17
  4. 3 versions Re-verified since Jan 31, 2025, no change to tracked fieldsv14-v16
  5. Trial status: Recruiting to Active, Not Recruitingv13 Show 4 more changesShow less
    • Enrollment target: estimated 32 to confirmed 20
    • Primary completion date: Jun 2025 to Sep 2025
    • Study completion date: Jun 2025 to Sep 2026
    • Site details revised
Show 11 earlier versionsHide 11 earlier versions
  1. Primary and study completion dates: Dec 31, 2024 to Jun 2025v12
  2. Re-verified, no change to tracked fieldsv11
  3. Site contact updatedv10
  4. Site contact updatedv9
  5. Re-verified, no change to tracked fieldsv8
  6. Primary completion date: Dec 31, 2023 to Dec 31, 2024
    • Start date: Aug 13, 2021 to Mar 21, 2022
    v7
  7. Primary completion date: Dec 31, 2022 to Dec 31, 2023v6
  8. Re-verified, no change to tracked fieldsv5
  9. Site contact updated
    • Eligibility criteria expanded, about 1 word
    v4
  10. Re-verified, no change to tracked fieldsv3
  11. Site contact updatedv2
  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 purposes of the study are to determine the maximum tolerated dose (MTD) and effectiveness of Artificial Antigen Presenting Cell (AAPC)-expanded donor T-cells administered as a single infusion after an allogeneic hematopoietic cell transplant (alloHCT) to treat patients with Acute Myeloid Leukemia (AML).
Trial Details
NCT Number NCT05015426
Lead Sponsor H. Lee Moffitt Cancer Center and Research Institute
Collaborators: Florida Department of Health
Conditions
(from sponsor)		 Acute Myeloid Leukemia
Related terms Leukemia, Myeloid, Acute
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov