drugset / Trial / NCT03926624
Trial of DFP-10917 vs Non-Intensive or Intensive Reinduction for AML Patients in 2nd/3rd/4th Salvage
RandomizedParallel-groupOpen-labelTreatment
Summary
Phase III, multicenter, randomized study with two arms (1:1 ratio) enrolling patients with AML relapsed/refractory after 2, 3, or 4 prior induction regimens: Experimental arm: DFP-10917 14-day continuous intravenous (IV) infusion at a dose of 6 mg/m²/day followed by a 14-day resting period per 28-day cycles. Control arm: Non-Intensive Reinduction (LoDAC, Azacitidine, Decitabine, Venetoclax Combination Regimens) or Intensive Reinduction (High and Intermediate Dose Cytarabine Regimens), depending on the patient's prior induction treatment.
Timeline
- Start
- 2019-11-22
- Primary completion
- 2026-01-07
- Completion
- 2026-01-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Azacitidine | Other / unclassified | 75 mg/m2 | Subcutaneous |
| Comparator | Cladribine | Small molecule | 5 mg/m2 | — |
| Comparator | Cytarabine | Small molecule | 20 mg | Subcutaneous |
| Comparator | Cytarabine | Small molecule | 20 mg/m2 | Subcutaneous |
| Comparator | Cytarabine | Small molecule | 1 g/kg | Subcutaneous |
| Comparator | Cytarabine | Small molecule | 1 g | Subcutaneous |
| Comparator | Cytarabine | Small molecule | 2 g/kg | Subcutaneous |
| Subject | DFP-10917 | Unknown | 6 mg/m2 | Intravenous |
| Comparator | Decitabine | Small molecule | 20 mg/m2 | Intravenous |
| Comparator | Etoposide | Small molecule | 80 mg/m2 | Intravenous |
| Comparator | Fludarabine | Small molecule | 30 mg/m2 | Intravenous |
| Comparator | Idarubicin | Small molecule | 8 mg/m2 | Intravenous |
| Comparator | Idarubicin | Small molecule | 10 mg/m2 | Intravenous |
| Comparator | Mitoxantrone | Small molecule | 6 mg/m2 | Intravenous |
| Comparator | Mitoxantrone | Small molecule | 10 mg/m2 | Intravenous |
| Comparator | Venetoclax | Small molecule | 400 mg | — |
| Comparator | Venetoclax | Small molecule | 600 mg | — |