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RAPHAEL: HMPL-306 vs Salvage Chemotherapy in IDH-mutated R/R AML
NCT06387069Phase 3
Key facts
- Status
- Recruiting
- Start
- Apr 2024
- Primary completion
- Dec 2028
- Countries
- 1
- Sponsor
- HUTCHMED
- Modality
- Small Molecules
- Drugs
- ranosidenib
- Conditions
- acute myeloid leukemia (AML)
01
Overview
Phase 3, randomised, open-label trial of ranosidenib in acute myeloid leukemia (AML) (2 arms), sponsored by HUTCHMED. Primary endpoint: Overall Survival up to 33 months. Started Apr 2024; status: recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
HMPL-306 Arm
HMPL-306 250mg QD (C1) -> 150mg QD (C2+)
Salvage Chemotherapy Arm
Investigator's choice of EA, FLAG, LoDAC, or Azacitidine
03
Who it enrols
Patients with R/R AML harboring IDH1 or IDH2 mutations, aged 18+, ECOG 0-2. Excludes prior IDH inhibitor therapy, known RAS/FLT3 hotspot mutations, and active CNS leukemia.
04
Endpoints
Primary
Overall Survival
Secondary
Complete Remission Rate
CR plus CRh Rate
Composite Complete Remission Rate
Pharmacokinetics
Duration of Response
Transfusion-dependence conversion ratio
Hematopoietic Stem Cell Transplantation Ratio
Safety (TEAE, TRAE, SAE)
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