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Phase 1/2 Study of Liposomal Annamycin for the Treatment of Subjects With Acute Myeloid Leukemia (AML) That is Refractory to or Relapsed After Standard Induction Therapy

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Trial Profile

Phase 1/2 Study of Liposomal Annamycin for the Treatment of Subjects With Acute Myeloid Leukemia (AML) That is Refractory to or Relapsed After Standard Induction Therapy

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 12 May 2022

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At a glance

  • Drugs Naxtarubicin (Primary)
  • Indications Acute myeloid leukaemia
  • Focus Adverse reactions; Registrational
  • Sponsors Moleculin

Most Recent Events

  • 05 May 2022 According to a Moleculin Biotech media release, the company has received an updated independent safety review in January 2022, of certain preliminary data for the first 30 patients which concluded there was no evidence of cardiotoxicity.
  • 13 Jul 2021 According to a Moleculin Biotech media release, the company expects to report topline results from this trial in the second half of 2022
  • 13 Jul 2021 According to a Moleculin Biotech media release, the amendment to this trial protocol allows for a change in the DLT criteria as it relates to transient grade 3 elevations and allows dosing of three additional patients in the 240 mg/m2 cohort. If no DLT is experienced with these next three patients, the Company plans to escalate dosing in new cohorts by 30 mg/m2 instead of the 60 mg/m2 previously planned, and with a de-escalation of 15 mg/m2 at the DLT dose if future patient experience a DLT.

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