At a glance
ClinicalIndex Comparison Record- ✓Relapsed/refractory primary AML with IDH1-R132 site mutation (Cohort 1) or IDH2-R140/R172 mutations (Cohort 2)
- ✓Age 18 years or older
- ✓ECOG performance status 0 to 2
- ✓Predicted survival greater than 12 weeks
- ✕Prior treatment with IDH1 inhibitors, IDH2 inhibitors, or IDH1/IDH2 dual target inhibitors
- ✕Known RAS or FLT3 hotspot mutations (unless documented to be negative at enrollment)
- ✕Serum total bilirubin higher than 1.5 times ULN (with exceptions for Gilbert's disease and liver invasion)
- ✕AST or ALT > 2.5 × ULN (or ≤ 5 × ULN if liver invasion)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Open-Label, Phase III Clinical Study to Evaluate the Efficacy and Safety of HMPL-306 vs. Salvage Chemotherapy Regimens in Patients With IDH1- and IDH2-mutated Relapsed/Refractory Acute Myeloid Leukemia (R/R AML)
In Brief
A Phase 3 clinical trial evaluating HMPL-306 Regimen and Salvage Chemotherapy Regimen for Acute Myeloid Leukemia. Currently recruiting, targeting 316 participants across 53 sites.
Signals
Detailed Summary
This study is a multicenter, randomized, open-label, phase III clinical study (RAPHAEL) to evaluate the efficacy, safety, and PK of HMPL-306 versus salvage chemotherapy in patients with R/R AML harboring IDH1 and IDH2 mutations.
Study Details
Timeline
Interventions
Patients will receive HMPL-306 monotherapy: HMPL-306 PO at 250 mg QD (C1) + 150 mg QD (starting from C2), 28 days as a cycle.
Patients in this regimen will receive treatment with one of the following regimens, and the regimen will be selected by the investigator based on the patient's condition: * EA±Mitox regimen: etoposide injection 100 mg/m2, cytarabine injection 100-150 mg/m2, mitoxantrone injection 8 mg/m2 QD IV for 5 consecutive days (Days 1-5). * FLAG ± Ida regimen: G-CSF injection 300 mcg/m2 QD SC for 5 consecutive days (Days 1-5); fludarabine injection 30 mg/m2 QD IV for 5 consecutive days (Days 2-6); cytarabine injection 1000-2000 mg/m2 QD IV for 5 consecutive days (Days 2-6); idarubicin injection 10 mg/m2 QD IV for 3 consecutive days (Days 2-4). * LoDAC: -Cytarabine Injection 20 mg every 12 hours, subcutaneous or IV for 10 consecutive days (Days 1-10). * Azacitidine: Azacitidine Injection 75 mg/m2, QD, subcutaneous or IV for 7 consecutive days (Days 1-7).