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 (Jun 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
Treatments studied
Other
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.
Frequently asked questions
Is NCT06387069 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior IDH1 inhibitor, IDH2 inhibitor, IDH1/IDH2 dual target inhibitor disqualifies patients from enrollment.
Does this trial require IDH1?
Yes, IDH1 R132 mutation is a required biomarker for enrollment.
Does this trial require IDH2?
Yes, IDH2 R140 mutation is a required biomarker for enrollment.
Does this trial require IDH2?
Yes, IDH2 R172 mutation is a required biomarker for enrollment.
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