A Study to Evaluate HMPL-306 in Patients With IDH1- and IDH2-mutated Acute Myeloid Leukemia - Trial NCT06387069
Access comprehensive clinical trial information for NCT06387069 through Pure Global AI's free database. This Phase 3 trial is sponsored by Hutchmed and is currently Not yet recruiting. The study focuses on Acute Myeloid Leukemia. Target enrollment is 316 participants.
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Study Focus
Sponsor & Location
Hutchmed
Timeline & Enrollment
Phase 3
Apr 30, 2024
Jun 29, 2028
Primary Outcome
OS
Summary
An open-label design is adopted in this study. All patients will first undergo pre-screening
 to determine the mutation status of IDH, and all patients will be assigned to the registry
 study of the corresponding cohorts of IDH1 and IDH2 based on the pre-screening results.
 Patients with both IDH1 and IDH2 mutations will be enrolled in the IDH2 cohort. This study is
 divided into two cohorts. Cohort 1 includes R/R AML patients with IDH1-R132 mutations; Cohort
 2 includes R/R AML patients with IDH2-R140 and R172 mutations. The two cohorts are designed
 independently and will be analyzed separately for statistical hypothesis testing. Patients in
 both cohorts will be randomized in a 1:1 ratio according to the central Interactive Web
 Response System (IWRS) into the test or control group, patients in the test group will
 receive HMPL-306 monotherapy at a dose of 250 mg once daily (QD) (Cycle 1, C1) + 150 mg QD
 [starting from Cycle 2 (C2)]. Patients in the control group will receive salvage chemotherapy
 (one of four options) consisting of two intensive chemotherapy regimens (MEC regimen and FLAG
 ± Ida regimen) and two non-intensive chemotherapy regimens (azacitidine and LoDAC)
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06387069
Non-Device Trial