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A Multicenter, Randomized, Open-Label, Phase III Clinical Study to Evaluate the Efficacy and Safety of HMPL-306 vs. Salvage Chemotherapy Regimens in Patients With IDH1- and IDH2-mutated Relapsed/Refractory Acute Myeloid Leukemia (R/R AML)

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Trial Profile

A Multicenter, Randomized, Open-Label, Phase III Clinical Study to Evaluate the Efficacy and Safety of HMPL-306 vs. Salvage Chemotherapy Regimens in Patients With IDH1- and IDH2-mutated Relapsed/Refractory Acute Myeloid Leukemia (R/R AML)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 25 Jun 2024

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At a glance

  • Drugs Ranosidenib (Primary) ; Azacitidine; Azacitidine; Cytarabine; Cytarabine; Etoposide; Fludarabine; Granulocyte colony-stimulating factors; Idarubicin; Mitoxantrone
  • Indications Acute myeloid leukaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms RAPHAEL
  • Sponsors HUTCHMED

    • Most Recent Events

    • 24 Jun 2024 According to a HUTCHMED media release, company will host R&D update in Shanghai, China, and via webcast on Tuesday, July 9, 2024 to provide updates on certain programs within HUTCHMED's extensive and innovative pipeline. This will include updates on the Phase III ESLIM-01 and Phase II/III ESLIM-02 studies he surufatinib Phase II/III study for metastatic pancreatic ductal adenocarcinoma, and the Phase III RAPHAEL study of our IDH1/2 inhibitor HMPL-306 in acute myeloid leukemia.
    • 13 May 2024 Planned number of patients changed from 316 to 320.
    • 13 May 2024 According to HUTCHMED media release, Prof Xiaojun Huang is the principle investigator of this trial.

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