Last updated on December 2019

Trial of DFP-10917 vs Non-Intensive or Intensive Reinduction for AML Patients in 2nd/3rd Salvage


Brief description of study

Phase III, multicenter, randomized study with two arms (1:1 ratio) enrolling patients with AML relapsed/refractory after 2 or 3 prior induction regimens:

Experimental arm: DFP-10917 14-day continuous intravenous (IV) infusion at a dose of 6 mg/m/day followed by a 14-day resting period per 28-day cycles.

Control arm: Non-Intensive Reinduction (LoDAC, Azacitidine, Decitabine) or Intensive Reinduction (High and Intermediate Dose Cytarabine Regimens), depending on the patient's prior induction treatment.

Detailed Study Description

Study to compare the rate of complete response (CR) and duration of CR, in patients with relapsed or refractory AML to two or three prior induction regimens that may have included intensive chemotherapy (e.g., "7+3" cytarabine and daunorubicin), epigenetic therapy (i.e., azacitidine or decitabine), or targeted therapy (e.g., FLT-3, IDH-1/2, BCL-2, monoclonal antibody), who will receive DFP-10917 versus non-intensive reinduction (LoDAC, azacitidine, decitabine) or intensive reinduction (high and intermediate dose cytarabine regimens) as a second or third salvage treatment.

Experimental Arm DFP-10917 Dose: 6 mg/m/day administered by continuous infusion for 14 days followed by a 14-day resting period per 28-day treatment cycle. If a patient experiences a significant treatment-related AE, the patient may undergo one dose reduction of DFP-10917 to 4 mg/m/day x 14 days for subsequent treatment cycles

Control arm: Non-Intensive Reinduction (LoDAC, Azacitidine, Decitabine) or Intensive Reinduction (High and Intermediate Dose Cytarabine Regimens), depending on the patient's prior induction treatment. Control treatment is to be selected only from among the following. Institutional practice for administering these treatments are permitted, but the dose and days of drug administration should be followed as below.

Non-Intensive Reinduction:

  • LoDAC: 20 mg Cytarabine administered by subcutaneous (SC) injection, twice daily (BID) for 10 days, plus best supportive care per 28-day treatment cycle
  • Azacitidine: 75 mg/m/day administered by SC for 7 consecutive days (or 5+2), plus best supportive care per 28-day treatment cycle
  • Decitabine: administered as continuous intravenous (CIV) infusion 20 mg/m x 5 days plus best supportive care per 28 day treatment cycle

Intensive Reinduction:

  • High DAC = cytarabine at doses of 1-2 g/m/day for up to 5 days, with a maximum total dose 10 g/m per course
  • FLAG = Days 1-5: fludarabine 30 mg/m IV over 30 minutes, Days 1-5: cytarabine 1 2 grm/m over 4 hours daily x 5, and granulocyte colony-stimulating factor 5 mcg/kg or 300 mcg/m until Polymorphonuclear Neutrophil (PMN) recovery, with or without idarubicin Days 1-3 at 8 mg/m IV daily x 3 (FLAG-Ida)
  • MEC = Days 1-6: mitoxantrone 6 mg/m IV bolus, etoposide 80 mg/m IV over 1 hour, and cytarabine 1 grm/m IV over 6 hrs
  • Intermediate DAC = cytarabine 20 mg/m IV daily x 5

The selection of control arm treatment will be determined by the investigator depending on the patient's prior initial induction and salvage treatment regimen(s), as well as the patient's clinical condition and comorbidities. The investigator will select the patient's control treatment from among the non-intensive or intensive regimens prior to study treatment randomization in order to balance treatment allocation between the experimental and control treatment arms.

Clinical Study Identifier: NCT03926624

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