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

• Status: Not yet recruiting
• Trial end date: 2026-05-14
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunshine Lake Pharma Co., Ltd.
• Treatments: Azacitidine; Cytarabine; Decitabine; Fludarabine; Idarubicin; Lenograstim

Criteria

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