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A Phase 1/2a, Open-Label, Dose Escalation, and Dose Expansion Study to Assess the Safety and Efficacy of GDX012 in Patients With Relapsed or Refractory Acute Myeloid Leukemia

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Trial Profile

A Phase 1/2a, Open-Label, Dose Escalation, and Dose Expansion Study to Assess the Safety and Efficacy of GDX012 in Patients With Relapsed or Refractory Acute Myeloid Leukemia

Status: Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 06 Jan 2026

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At a glance

  • Drugs TAK 012 (Primary) ; Cyclophosphamide; Fludarabine
  • Indications Acute myeloid leukaemia
  • Focus Adverse reactions
  • Sponsors Takeda

Most Recent Events

  • 04 Dec 2025 Actual primary completion date changed from 19 Aug 2025 to 20 Aug 2025.
  • 22 Aug 2025 Planned End Date changed from 30 Jun 2027 to 12 May 2026.
  • 22 Aug 2025 Planned primary completion date changed from 1 Apr 2026 to 19 Aug 2025.

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