Clinical Trial

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

Recruiting Phase 3
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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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2022-10-16; most recent amendment 2026-04-27.
Status change: Not Yet Recruiting → Recruiting 2023-03-20
Trial Details
NCT Number NCT05586074
Lead Sponsor Sunshine Lake Pharma Co., Ltd.
Conditions Leukemia, Acute Myeloid (AML)
Enrollment 324 participants
Start Date 2023-03-03
Primary Completion 2027-11-30 (estimated)
Study Completion 2028-05-30 (estimated)
Updated on ClinicalTrials.gov 2026-04-28