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

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.

Trial Details

NCT ID
NCT06387069
Phase
PHASE3
Sponsor
Hutchmed
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • HMPL-306 Regimen
  • Salvage Chemotherapy Regimen
Locations (sample)
  • Hefei, Anhui, China|31.86389,117.28083
  • Beijing, Beijing Municipality, China|39.9075,116.39723
  • Chongqing, Chongqing Municipality, China|29.56026,106.55771
  • Fuzhou, Fujian, China|26.06139,119.30611
  • Quanzhou, Fujian, China|24.91389,118.58583

Key Eligibility Criteria

  • 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;

For full eligibility, visit ClinicalTrials.gov.

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