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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05586074
Other study ID # HEC73543-AML-301
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date March 3, 2023
Est. completion date May 14, 2026

Study information

Verified date October 2022
Source Sunshine Lake Pharma Co., Ltd.
Contact Lejie Zheng, MSc
Phone 86 18511702129
Email zhenglejie@hec.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 324
Est. completion date May 14, 2026
Est. primary completion date February 10, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Drug:
Clifutinib
tablet, oral
LoDAC
subcutaneous (SC) or intravenous (IV) injection
Azacitidine
SC or IV
Decitabine
IV
Ara-C±IDA
SC and IV
FLAG-IDA
SC and IV

Locations

Country Name City State
China the First Affiliated Hospital,College of Medicine,Zhejiang University Hanzhou

Sponsors (1)

Lead Sponsor Collaborator
Sunshine Lake Pharma Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary OS Overall survival was defined as the time from the date of randomization until the date of death from any cause From the date of randomization until the date of death from any cause, assessed up to 5 years
Primary CR/CRh rate The CR/CRh rate was defined as the number of subjects who achieved either CR or CRh at any of the postbaseline visits divided by the number of subjects in the analysis population 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 EFS EFS was defined as the time from the date of randomization until the date of documented relapse, treatment failure, new anti-leukemia therapy or death from any cause From randomization until the data cut-off date of June 2026, median time of follow-up for OS was 15 months
Secondary CR rate The CR rate was defined as the number of subjects who achieved the best response of CR divided by the number of subjects in the analysis population 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
Secondary CRc Rate CRc rate was defined as the number of subjects who achieved the best response of CRc (CR, CRh or CRi divided by the number of subjects in the analysis population 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
Secondary Adverse Events Number of Participants With Adverse Events 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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT02421939 - A Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase (FLT3) Mutation Phase 3