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

Phase 3 Recruiting 316 enrolled Hutchmed

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2024-04-26
Primary completion: 2028-12-31
Completion: 2029-09-30

Publications

Hu L, Wei X, Zhao W, Hu Y, Li J, Dong Y, Gong T, Zhang X, Xu Y, Zhang Y, Xu C, Zhang C, Cai Z, Jing H, Mi R, Wu W, He W, Wang H, Tang Q, Jiang Z, Liu H, Chen G, Sun J, Chen J, Yan S, Yan H, Wangwu J, Zhong Z, Wang L, Fan S, Shi M, Su W, Huang X. HMPL-306 in relapsed or refractory IDH1- and/or IDH2-mutated acute myeloid leukemia: A phase 1 study. Med. 2025 Jun 13;6(6):100575. doi: 10.1016/j.medj.2025.100575. Epub 2025 Jan 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Azacitidine	Other / unclassified	75 mg/m2	Subcutaneous
Comparator	Cytarabine	Small molecule	20 mg	Intravenous
Comparator	Cytarabine	Small molecule	100 mg/m2	Intravenous
Comparator	Cytarabine	Small molecule	150 mg/m2	Intravenous
Comparator	Cytarabine	Small molecule	200 mg/m2	Intravenous
Comparator	Cytarabine	Small molecule	1000 mg/m2	Intravenous
Comparator	Cytarabine	Small molecule	2000 mg/m2	Intravenous
Comparator	Etoposide	Small molecule	100 mg/m2	Intravenous
Comparator	Fludarabine	Small molecule	30 mg/m2	Intravenous
Comparator	Idarubicin	Small molecule	10 mg/m2	Intravenous
Comparator	Mitoxantrone	Small molecule	8 mg/m2	Intravenous
Comparator	Mitoxantrone	Small molecule	24 mg/m2	Intravenous
Comparator	Mitoxantrone	Small molecule	32 mg/m2	Intravenous
Subject	RANOSIDENIB	Small molecule	150 mg	Oral

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

Summary

Timeline

Publications

Drugs

Indications