A Study of GDX012 in Adults With Relapsed or Refractory Acute Myeloid Leukemia

StatusTerminated
PhasePhase 1/2
SponsorTakeda
Started

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Record History

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  1. Results posted: Sep 25, 2026 Show 4 more changesShow less
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 5 of 5 entries
    • Site details revised at 2 of 11 sites
    • Study description expanded, about 3 words
  2. Primary endpoints: 3 to 2
    • Secondary endpoints revised (5)
    • Study arms: 2 to 3
    • Study description expanded, about 2 words
    v18
  3. Trial terminated Sponsor's reason: Sponsor decision (No safety concern)
    • Study completion moved earlier from May 12, 2026 to Nov 30, 2025
    v17
  4. Enrollment target: 14 to 16
    • Study sites: 14 to 11
    v16
  5. Primary completion date: Aug 19, 2025 to Aug 20, 2025v15
Show 13 earlier versionsHide 13 earlier versions
  1. Re-verified, no change to tracked fieldsv14
  2. Trial status: Recruiting to Active, Not Recruitingv13 Show 4 more changesShow less
    • Enrollment target: estimated 53 to confirmed 14
    • Primary completion date: Apr 1, 2026 to Aug 19, 2025
    • Study completion date: Jun 30, 2027 to May 12, 2026
    • Site details revised at 14 of 14 sites
  3. Re-verified, no change to tracked fieldsv12
  4. Site details revised at 1 of 14 sitesv11
  5. Site details revised at 1 of 14 sitesv10
  6. Site details revised at 1 of 14 sitesv9
  7. Re-verified, no change to tracked fieldsv8
  8. Site contacts updated at 14 of 14 sitesv7
  9. Site contacts updated at 14 of 14 sitesv6
  10. Site details revised at 13 of 14 sitesv5
  11. Re-verified, no change to tracked fieldsv4
  12. Site details revised at 2 of 14 sitesv3
  13. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 3 to 14
    • Start date changed from estimate of Jul 7, 2023 to Jul 11, 2023
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Takeda
222 trials monitored
See 14 trials at risk
Leukemia
2,957 trials monitored
See 176 trials at risk
Acute Myeloid Leukemia (AML)
1,275 trials monitored
See 74 trials at risk
GDX012 is a novel cell therapy developed for the treatment of certain types of cancer, including Acute Myeloid Leukemia (AML). The main aims of the study are to learn how safe GDX012 is, how treatment with GDX012 is tolerated and to determine the best dose of GDX012.
Trial Details
NCT Number NCT05886491
Lead Sponsor Takeda
Conditions
(from sponsor)		 Leukemia
Related terms Leukemia, Leukemia, Myeloid, Acute
Enrollment 16 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov