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Trial Title:
HEC73543 Versus Salvage Chemotherapy in R/R FLT3-ITD AML
NCT ID:
NCT05586074
Condition:
Leukemia, Acute Myeloid (AML)
Conditions: Official terms:
Leukemia
Leukemia, Myeloid, Acute
Cytarabine
Fludarabine
Azacitidine
Decitabine
Idarubicin
Lenograstim
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Clifutinib
Description:
tablet, oral
Arm group label:
Clifutinib
Other name:
HEC73543
Intervention type:
Drug
Intervention name:
LoDAC
Description:
subcutaneous (SC) or intravenous (IV) injection
Arm group label:
Salvage Chemotherapy
Other name:
Low Dose Cytarabine
Intervention type:
Drug
Intervention name:
Azacitidine
Description:
SC or IV
Arm group label:
Salvage Chemotherapy
Intervention type:
Drug
Intervention name:
Decitabine
Description:
IV
Arm group label:
Salvage Chemotherapy
Intervention type:
Drug
Intervention name:
Ara-C±IDA
Description:
SC and IV
Arm group label:
Salvage Chemotherapy
Other name:
Cytarabine, Idarubicin
Intervention type:
Drug
Intervention name:
FLAG-IDA
Description:
SC and IV
Arm group label:
Salvage Chemotherapy
Other name:
Granulocyte-Colony Stimulating Factor (G-CSF), Fludarabine, Cytarabine, Idarubicin
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
the First Affiliated Hospital,College of Medicine,Zhejiang University
Address:
City:
Hanzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Jie Jin, Doctor
Phone:
0571-87236685
Email:
jiej0503@163.com
Start date:
March 3, 2023
Completion date:
May 14, 2026
Lead sponsor:
Agency:
Sunshine Lake Pharma Co., Ltd.
Agency class:
Industry
Source:
Sunshine Lake Pharma Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05586074
