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: 04 Feb 2024
Price :
$35
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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
- 30 Jan 2024 According to a Delta-Fly Pharma media release, company plans to shows the Interium results when the data is ready to disclose as there are long term surviving patients (N=150) in this study so company continue to follow up these patients without any data cut-off for the time being to determine the final overall survival results of the study.
- 30 Jun 2023 According to a Delta-Fly Pharma media release, the interim analysis for the study shall be done based on outcome measurements (complete remission rate, overall survival and safety) as follows- The 1st data processing of this study shall be done on the middle July in 2023 and the 2nd data processing shall be done by the end of November 2023.Studys abstract shall be submitted by the principal investigator at the annual meeting of ASH 2023 and at the annual meeting of ASCO 2024.
- 15 May 2023 According to a Delta-Fly Pharma media release, 150 patients have been enrolled and the 1st interim analysis of this study shall be done for NDA approval to the FDA in US soon after confirmation of the superiority of DFP-10917 arm.