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A Pivotal Phase 2/3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Adaptive Design Study of L Annamycin for Injection in Combination with Cytarabine Injection Versus Placebo in Combination with Cytarabine Injection As Second Line Therapy for Remission Induction in Adult Subjects with Refractory/Relapsed Acute Myeloid Leukemia

Trial Profile

A Pivotal Phase 2/3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Adaptive Design Study of L Annamycin for Injection in Combination with Cytarabine Injection Versus Placebo in Combination with Cytarabine Injection As Second Line Therapy for Remission Induction in Adult Subjects with Refractory/Relapsed Acute Myeloid Leukemia

Status: Not yet recruiting
Phase of Trial: Phase II/III

Latest Information Update: 20 Mar 2025

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At a glance

  • Drugs Annamycin (Primary) ; Cytarabine
  • Indications Acute myeloid leukaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms MIRACLE
  • Sponsors Moleculin Biotech
  • Most Recent Events

    • 06 Mar 2025 According to a Moleculin Biotech media release, initial data readout of the phase 3 trial anticipated in second half of 2025.
    • 26 Feb 2025 Planned initiation date changed from 1 Jan 2025 to 1 Mar 2025.
    • 13 Feb 2025 According to a Moleculin Biotech media release, the company expects to reach the first unblinding (45 subjects) in the second half of 2025, in addition to the second unblinding, which is expected in the first half of 2026. This accelerated estimated timeline is due to the positive response the Company received in meetings during December with potential investigators regarding recruitment for the trial.

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