Trial Profile

A phase 3 study of Annamycin for the treatment of AML patients : MIRACLE2

Status: Recruiting

Phase of Trial: Phase III

Latest Information Update: 13 Feb 2025

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At a glance

11 Feb 2025 According to a Moleculin Biotech media release, Status changed from planning to recruiting.
11 Feb 2025 According to a Moleculin Biotech media release, The amended protocol allows for the unblinding of preliminary primary efficacy data (Complete Remission or CR) and safety/tolerability of the three arms at 45 subjects, in addition to the conclusion of Part A (at 75 to 90 subjects). This early unblinding will yield 30 subjects with Annamycin (190mg/m2 and 230/m2) and HiDAC and 15 subjects with just HiDAC.
11 Feb 2025 According to a Moleculin Biotech media release, the company on track for unblinded preliminary data from the first 45 subjects in the second half of this year.

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