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

ConditionAcute Myeloid Leukemia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorHutchmed

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

Patients who received prior treatment with IDH1 inhibitors, IDH2 inhibitors, or IDH1/IDH2 dual target inhibitors;

Patients with known RAS or FLT3 hotspot mutations (patients who have test results definitely switched to negative at the time of enrollment can be enrolled);

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • HMPL-306 Regimen

    Drug

    Patients will receive HMPL-306 monotherapy: HMPL-306 PO at 250 mg QD (C1) + 150 mg QD (starting from C2), 28 days as a cycle.

  • Salvage Chemotherapy Regimen

    Drug

    Patients in this regimen will receive treatment with one of the following regimens, and the regimen will be selected by the investigator based on the patient's condition: * EA±Mitox regimen: etoposide injection 100 mg/m2, cytarabine injection 100-150 mg/m2, mitoxantrone injection 8 mg/m2 QD IV for 5 consecutive days (Days 1-5). * FLAG ± Ida regimen: G-CSF injection 300 mcg/m2 QD SC for 5 consecutive days (Days 1-5); fludarabine injection 30 mg/m2 QD IV for 5 consecutive days (Days 2-6); cytarabine injection 1000-2000 mg/m2 QD IV for 5 consecutive days (Days 2-6); idarubicin injection 10 mg/m2 QD IV for 3 consecutive days (Days 2-4). * LoDAC: -Cytarabine Injection 20 mg every 12 hours, subcutaneous or IV for 10 consecutive days (Days 1-10). * Azacitidine: Azacitidine Injection 75 mg/m2, QD, subcutaneous or IV for 7 consecutive days (Days 1-7).

Treatment groups

316 Participants
are divided into 2 treatment groups
Group A: HMPL-306 armExperimental treatment 1 intervention
Group B: Salvage treatment armActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

OS

Overall survival (OS)

Time frame
Up to approximately 33 months

Secondary outcomes

1

CR rate

Proportion of patients who achieve a complete remission (CR)

Time frame
Up to approximately 33 months
2

CR + CRh rate

Proportion of patients who achieve complete remission plus complete remission with partial hematologic recovery rate

Time frame
Up to approximately 33 months
3

CR + CRi + CRh rate

Proportion of patients who achieve complete remission plus complete remission with incomplete hematologic recovery and partial hematologic recovery rate

Time frame
Up to approximately 33 months
4

Assessments for PK (pharmacokinetics)

Maximum Plasma concentration (Cmax) of drug

Time frame
Day1 of cycle 1, 3, 5 (each cycle is 28 days)，up to approximately 33 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hutchmed

Lead sponsor

Source ClinicalTrials.gov
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