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

NCT05586074 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 324

Last updated 2026-04-28

No results posted yet for this study

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.

Conditions

  • Leukemia, Acute Myeloid (AML)

Interventions

DRUG

Clifutinib

tablet, oral

DRUG

LoDAC

subcutaneous (SC) or intravenous (IV) injection

DRUG

Azacitidine

SC or IV

DRUG

Decitabine

IV

DRUG

Ara-C±IDA

SC and IV

DRUG

FLAG-IDA

SC and IV

Sponsors & Collaborators

  • Sunshine Lake Pharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Jie Jin, MD, PhD · First Affiliated Hospital of Zhejiang University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-03
Primary Completion
2027-11-30
Completion
2028-05-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05586074 on ClinicalTrials.gov