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

  • End date
    May 14, 2026
  • participants needed
  • sponsor
    Sunshine Lake Pharma Co., Ltd.
Updated on 11 April 2023


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.


Subjects who are at least 18 years and above at the time of signing informed consent may participate in this study. Subjects will be randomized in a 2:1 ratio to receive Clifutinib or salvage chemotherapy. Subjects will enter the screening period up to 28 days prior to the start of treatment. Prior to randomization, a salvage chemotherapy regimen will be pre-selected for each subjects; options will include low-dose cytarabine (LoDAC), azacitidine, decitabine, Ara-C±IDA or FLAG±IDA. The randomization will be stratified by response to first-line therapy and pre-selected salvage chemotherapy. Participants will be administered treatment over continuous 28-day cycles.

After treatment discontinuation, participants will have a end-of-treatment visit within 7 days after treatment discontinuation, followed by a 30-day follow-up for safety. After that, long term follow-up will be done every 90 days.

Condition Leukemia, Acute Myeloid (AML)
Treatment Decitabine, Azacitidine, Clifutinib, LoDAC, Ara-C±IDA, FLAG-IDA
Clinical Study IdentifierNCT05586074
SponsorSunshine Lake Pharma Co., Ltd.
Last Modified on11 April 2023


Yes No Not Sure

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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