A Study to Evaluate HMPL-306 in Patients With IDH1or IDH2-mutated Acute Myeloid Leukemia
ConditionAcute Myeloid Leukemia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorHutchmed
About this trial
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.
Eligibility criteria
Qualifiers
Have signed the ICF;
Be able to follow the requirements of study protocol;
Age ≥18 years;
Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 to 2;
Disqualifiers
Patients who received prior treatment with IDH1 inhibitors, IDH2 inhibitors, or IDH1/IDH2 dual target inhibitors;
Patients with known RAS or FLT3 hotspot mutations (patients who have test results definitely switched to negative at the time of enrollment can be enrolled);
AST or ALT > 2.5 × ULN (if leukemia invades the liver, patients with AST and ALT levels ≤ 5 × ULN can be enrolled);
Estimated creatinine clearance by Cockcroft-Gault formula < 50 mL/min or creatinine > 1.5 × ULN;
Trial design
Treatments tested in this trial
- HMPL-306 Regimen
- Salvage Chemotherapy Regimen
Treatment groups
316 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov