Stopped: The study was terminated due to enrollment challenges.
The purpose of the phase 1 portion (dose escalation) of the study was to establish an optimally safe and biologically active recommended phase 2 dose (RP2D) and/or to determine maximum tolerated dose (MTD) for gilteritinib in sequential combination with fludarabine, cytarabine and granulocyte colony-stimulating factor (FLAG). The purpose of the phase 2 portion (dose expansion) was to determine complete remission (CR) rates and composite complete remission (CRc) rates after two cycles of therapy. The study also assessed safety, tolerability and toxicities of gilteritinib in combination with FLAG, evaluated FLT3 inhibition, assessed pharmacokinetics (PK), performed serial measurements of minimal residual disease, obtained preliminary estimates of 1-year event free survival (EFS) and overall survival (OS) rate and assessed the acceptability as well as palatability of the formulation. One cycle was defined as 28 days of treatment. A participant completing 1 or 2 treatment cycles in phase 1 or 2 had the option to participate in long term treatment (LTT) with gilteritinib (for up to 2 years).
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Phase 1: Maximum Tolerated Dose (MTD) of Gilteritinib
Timeframe: C1D1 up to day 28
Phase 1: Recommended Phase 2 Dose (RP2D) of Gilteritinib
Timeframe: C1D1 up to day 28
Phase 2: Complete Remission (CR) Rate
Timeframe: From date of randomization to end of induction (induction= 1-2 cycles, each cycle = 28 days)
Phase 2: Composite CR (CRc) Rate
Timeframe: From date of randomization to end of induction (induction= 1-2 cycles, each cycle = 28 days)
Duration of CR
Timeframe: From the date of first CR until the date of documented relapse for participants who achieved CR (Maximum duration: 28 months)
Phase 1: Number of Participants With Dose Limiting Toxicity (DLT) of Gilteritinib
Timeframe: C1D1 up to day 28