Clinical trial NCT05586074: HEC73543 Versus Salvage Chemotherapy in R/R FLT3-ITD AML
Official title: HEC73543 Versus Salvage Chemotherapy in Relapsed or Refractory FLT3-ITD Acute Myeloid Leukemia: a Multicenter, Open-label, Randomized Phase 3 Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Leukemia, Acute Myeloid (AML)
Lead sponsor: Sunshine Lake Pharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-10-19
Enrollment: 324
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
measure: OS
timeFrame: From the date of randomization until the date of death from any cause, assessed up to 5 years
measure: CR/CRh rate
timeFrame: From randomization until the data cut-off date of April 2025, all subjects included in the primary analysis of CR/CRh rate were followed up at least 4 months
Secondary outcomes:
measure: EFS
timeFrame: From randomization until the data cut-off date of June 2026, median time of follow-up for OS was 15 months
measure: CR rate
timeFrame: From randomization until the data cut-off date of June 2026, all subjects included in the analysis of CR rate were followed up at least 4 months
measure: CRc Rate
timeFrame: From randomization until the data cut-off date of June 2026, all subjects included in the analysis of CRc rate were followed up at least 4 months
measure: Adverse Events
timeFrame: From ICF signature date up to 30 days after the last dose of study drug, median treatment duration for Clifutinib was 140 days versus salvage chemotherapy 140 days
Other outcomes:
Locations:
city: Hanzhou
country: China
facility: the First Affiliated Hospital,College of Medicine,Zhejiang University
Study officials:
affiliation: First Affiliated Hospital of Zhejiang University
name: Jie Jin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: