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HEC73543 Versus Salvage Chemotherapy in R/R FLT3-ITD AML

RecruitingPhase 3Ages 18 Years - anyAllSunshine Lake Pharma Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

A randomized,multicenter, open-label Phase III, clinical study is conducted to evaluate the clinical benefit Clifutinib in Chinese patients with relapsed/ refractory (R/R) FLT3-mutated AML as shown with overall survival compared to salvage chemotherapy, and also to investigate the efficacy of Clifutinib as assessed by CR/CRh rate in these subjects.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Subject is ≥ 18 years of age at the time of obtaining informed consent. * Subject has a diagnosis of primary acute myeloid leukemia (AML) or AML secondary to myelodysplastic syndrome (MDS) according to WHO classification; * Subject is refractory to or relapsed after first-line AML therapy (with or without hematopoietic stem cell transplant ) * Subject is positive for FLT3 mutation in bone marrow or whole blood as determined by the central lab * Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 * Subject is eligible for pre-selected salvage chemotherapy at the investigator's discretion Exclusion Criteria: * Subject has received prior treatment with other FLT3 inhibitors * Subject has AML that has relapsed after or is refractory to more than 1 line of therapy * Subject has an active uncontrolled infection * Subject is known to have human immunodeficiency virus infection * Subject has any condition which, in the investigator's opinion, makes the subject unsuitable for study participation
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What it tests

  • Clifutinib
  • LoDAC
  • Azacitidine
  • Decitabine
  • Ara-C±IDA
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Where

1 site
the First Affiliated Hospital,College of Medicine,Zhejiang University
Hanzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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