Clinical Trial

A Study to Evaluate HMPL-306 in Patients With IDH1or IDH2-mutated Acute Myeloid Leukemia

Recruiting Phase 3
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-04-24; most recent amendment 2025-08-11.
Status change: Not Yet Recruiting → Recruiting 2024-05-28
Trial Details
NCT Number NCT06387069
Lead Sponsor Hutchmed
Conditions Acute Myeloid Leukemia
Enrollment 316 participants
Start Date 2024-04-26
Primary Completion 2028-12-31 (estimated)
Study Completion 2029-09-30 (estimated)
Updated on ClinicalTrials.gov 2025-08-14