OncoMatch/Clinical Trials/NCT06387069
A Study to Evaluate HMPL-306 in Patients With IDH1or IDH2-mutated Acute Myeloid Leukemia
Is NCT06387069 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including HMPL-306 Regimen and Salvage Chemotherapy Regimen for acute myeloid leukemia.
Treatment: HMPL-306 Regimen · Salvage Chemotherapy Regimen — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: IDH1 R132 mutation
Cohort 1: Patients with R/R primary AML harboring IDH1-R132 site mutation
Required: IDH2 R140 mutation
Cohort 2: Patients with R/R primary AML harboring IDH2-R140/R172 mutations
Required: IDH2 R172 mutation
Cohort 2: Patients with R/R primary AML harboring IDH2-R140/R172 mutations
Required: KRAS G12 mutation
KRAS mutations: G12 or G13 (exon 2); Q61 (exon 3) [excluded if present, but eligible if negative at enrollment]
Required: KRAS G13 mutation
KRAS mutations: G12 or G13 (exon 2); Q61 (exon 3) [excluded if present, but eligible if negative at enrollment]
Required: KRAS Q61 mutation
KRAS mutations: G12 or G13 (exon 2); Q61 (exon 3) [excluded if present, but eligible if negative at enrollment]
Required: NRAS G12 mutation
NRAS mutations: G12 or G13 (exon 2); Q61 (exon 3) [excluded if present, but eligible if negative at enrollment]
Required: NRAS G13 mutation
NRAS mutations: G12 or G13 (exon 2); Q61 (exon 3) [excluded if present, but eligible if negative at enrollment]
Required: NRAS Q61 mutation
NRAS mutations: G12 or G13 (exon 2); Q61 (exon 3) [excluded if present, but eligible if negative at enrollment]
Required: FLT3 ITD
FLT3 mutations: ITD; TKD (D835 or I836) [excluded if present, but eligible if negative at enrollment]
Required: FLT3 TKD D835 mutation
FLT3 mutations: ITD; TKD (D835 or I836) [excluded if present, but eligible if negative at enrollment]
Required: FLT3 TKD I836 mutation
FLT3 mutations: ITD; TKD (D835 or I836) [excluded if present, but eligible if negative at enrollment]
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: IDH1 inhibitor
Patients who received prior treatment with IDH1 inhibitors
Cannot have received: IDH2 inhibitor
Patients who received prior treatment with IDH2 inhibitors
Cannot have received: IDH1/IDH2 dual target inhibitor
Patients who received prior treatment with IDH1/IDH2 dual target inhibitors
Lab requirements
Kidney function
Estimated creatinine clearance by Cockcroft-Gault formula ≥ 50 mL/min and creatinine ≤ 1.5 × ULN
Liver function
Serum total bilirubin (TBIL) ≤ 1.5 × ULN (except Gilbert's disease with normal ALT/AST and TBIL ≤ 3 × ULN); AST or ALT ≤ 2.5 × ULN (≤ 5 × ULN if leukemia invades the liver)
Cardiac function
No clinically significant rhythm or conduction abnormalities requiring intervention; no NYHA Class II or above CHF; LVEF ≥ 45%; no congenital long QT syndrome or QTcF >470 msec (females)/>450 msec (males); no uncontrolled hypertension (SBP >160 mmHg or DBP >100 mmHg)
Inadequate organ function, as defined below: Serum total bilirubin (TBIL) higher than 1.5 times the upper limit of normal (ULN), excluding the following patients: Patients with Gilbert's disease, with normal alanine aminotransferase (ALT) and aspartate aminotransferase (AST), and serum TBIL ≤ 3 × ULN. 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; cardiac function-related criteria as listed.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify