HEC73543 Versus Salvage Chemotherapy in Relapsed or Refractory FLT3-ITD Acute Myeloid Leukemia: a Multicenter, Open-label, Randomized Phase 3 Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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
Locations
Other Locations
China
the First Affiliated Hospital,College of Medicine,Zhejiang University
RECRUITING
Hanzhou
Contact Information
Primary
Yingzhi Jiang, MSc
jiangyingzhi@hec.cn
86 13692244182
Time Frame
Start Date:2023-03-03
Estimated Completion Date:2027-06-14
Participants
Target number of participants:324
Treatments
Experimental: Clifutinib
Subjects received 40 mg dose orally once a day in continuous 28-day cycles, at least 2 hours before and after food. Clifutinib treatment continued until sujects met one of the treatment discontinuation criteria.
Active_comparator: Salvage Chemotherapy
Subjects received chemotherapy in 28-day cycles. Subjects on Low-Dose Cytarabine (LoDAC) received 10 mg of cytarabine twice daily by subcutaneous (SC) or intravenous (IV) injection for 10\~14 days. Subjects on azacitidine received 75 mg/m\^2 daily by SC for 7 days. Subjects on decitabine received 20 mg/m\^2 daily by IV injection for 5 days. Subjects on LoDAC or azacitidine or decitabine treatment continued until they met discontinuation criteria. Subjects on Ara-C±IDA chemotherapy received cytarabine 1\~3 g/m\^2 daily by IV for 3 days and idarubicin 10 mg/m\^2 daily by IV for 3 days. Participants on FLAG-IDA chemotherapy received G-CSF 300 μg/m\^2 daily by SC for 6 days (days 1-6), fludarabine 30 mg/m\^2 daily by IV for 5 days (days 2-6), cytarabine 1\~2 g/m\^2 daily by IV for 5 days (days 2-6) and idarubicin 10 mg/m\^2 daily by IV for 3 days (days 2-4). Subjects receiving Ara-C±IDA or FLAG-IDA received 1 cycle of therapy and were assessed for response on day 28+/-2 days.