NCT05586074

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

HEC73543 Versus Salvage Chemotherapy in Relapsed or Refractory FLT3-ITD Acute Myeloid Leukemia: a Multicenter, Open-label, Randomized Phase 3 Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 324 (estimated)
• Sponsor: Sunshine Lake Pharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Leukemia, Acute Myeloid (AML)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-03-03
• Primary completion: 2026-03-10
• Completion: 2027-06-14
• First posted: 2022-10-19
• Last updated: 2025-04-09

Locations

1 site across 1 country: China