HEC73543 Versus Salvage Chemotherapy in R/R FLT3-ITD AML
ConditionLeukemia, Acute Myeloid (AML)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSunshine Lake Pharma Co., Ltd.
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Clifutinib
- LoDAC
- Azacitidine
- Decitabine
- Ara-C±IDA
- FLAG-IDA
Treatment groups
324 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov