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Phase 3 Randomized Trial of DFP-10917 vs Non-Intensive Reinduction (LoDAC, Azacitidine, Decitabine, Venetoclax Combination Regimens) or Intensive Reinduction (High & Intermediate Dose Cytarabine Regimens) for Acute Myelogenous Leukemia Patients in Second, Third, or Fourth Salvage

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Trial Profile

Phase 3 Randomized Trial of DFP-10917 vs Non-Intensive Reinduction (LoDAC, Azacitidine, Decitabine, Venetoclax Combination Regimens) or Intensive Reinduction (High & Intermediate Dose Cytarabine Regimens) for Acute Myelogenous Leukemia Patients in Second, Third, or Fourth Salvage

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 06 Mar 2025

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At a glance

  • Drugs Radgocitabine (Primary) ; Azacitidine; Cladribine; Cytarabine; Decitabine; Etoposide; Fludarabine; Idarubicin; Mitoxantrone; Venetoclax
  • Indications Acute myeloid leukaemia
  • Focus Registrational; Therapeutic Use
  • Sponsors Delta-Fly Pharma

Most Recent Events

  • 03 Mar 2025 Planned End Date changed from 1 Dec 2022 to 1 Jun 2026.
  • 03 Mar 2025 Planned primary completion date changed from 1 Dec 2022 to 1 Dec 2025.
  • 09 Dec 2024 According to Delta-Fly Pharma media release, the data cleaning processes for interim analysis are currently underway once this is completed, the results will be submitted to the Independent Data Safety Monitoring Committee (DSMB) along with electrocardiogram and pharmacokinetic study results for their advice.

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