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

NCT05586074 | Recruiting Phase 3 DMC

• 1 other identifier: HEC73543-AML-301
• Study Type: interventional
• Target: 324
• Locations: 1 country
• Sites: 1

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.

Conditions

Leukemia, Acute Myeloid (AML)

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• EFS

  From randomization until the data cut-off date of June 2026, median time of follow-up for OS was 15 months

• CR rate

  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

• CRc Rate

  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

• 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

Study Arms (2)

Clifutinib

EXPERIMENTAL

Subjects received 40 mg dose orally once a day in continuous 28-day cycles, at least 2 hours before and after food. Clifutinib treatment continued until sujects met one of the treatment discontinuation criteria.

Drug: Clifutinib

Salvage Chemotherapy

ACTIVE COMPARATOR

Subjects received chemotherapy in 28-day cycles. Subjects on Low-Dose Cytarabine (LoDAC) received 10 mg of cytarabine twice daily by subcutaneous (SC) or intravenous (IV) injection for 10\~14 days. Subjects on azacitidine received 75 mg/m\^2 daily by SC for 7 days. Subjects on decitabine received 20 mg/m\^2 daily by IV injection for 5 days. Subjects on LoDAC or azacitidine or decitabine treatment continued until they met discontinuation criteria. Subjects on Ara-C±IDA chemotherapy received cytarabine 1\~3 g/m\^2 daily by IV for 3 days and idarubicin 10 mg/m\^2 daily by IV for 3 days. Participants on FLAG-IDA chemotherapy received G-CSF 300 μg/m\^2 daily by SC for 6 days (days 1-6), fludarabine 30 mg/m\^2 daily by IV for 5 days (days 2-6), cytarabine 1\~2 g/m\^2 daily by IV for 5 days (days 2-6) and idarubicin 10 mg/m\^2 daily by IV for 3 days (days 2-4). Subjects receiving Ara-C±IDA or FLAG-IDA received 1 cycle of therapy and were assessed for response on day 28+/-2 days.

Drug: LoDAC; Drug: Azacitidine; Drug: Decitabine; Drug: Ara-C±IDA; Drug: FLAG-IDA

Interventions

Clifutinib DRUG

tablet, oral

Also known as: HEC73543

Clifutinib

LoDAC DRUG

subcutaneous (SC) or intravenous (IV) injection

Also known as: Low Dose Cytarabine

Salvage Chemotherapy

Azacitidine DRUG

SC or IV

Salvage Chemotherapy

Decitabine DRUG

IV

Salvage Chemotherapy

Ara-C±IDA DRUG

SC and IV

Also known as: Cytarabine, Idarubicin

Salvage Chemotherapy

FLAG-IDA DRUG

SC and IV

Also known as: Granulocyte-Colony Stimulating Factor (G-CSF), Fludarabine, Cytarabine, Idarubicin

Salvage Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunshine Lake Pharma Co., Ltd.: lead

Study Sites (1)

the First Affiliated Hospital,College of Medicine,Zhejiang University

Hanzhou, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Cytarabine; Azacitidine; Decitabine; Idarubicin; Ida-FLAG protocol; Granulocyte Colony-Stimulating Factor; fludarabine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Aza Compounds; Organic Chemicals; Ribonucleosides; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Jie Jin, MD, PhD

  First Affiliated Hospital of Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yingzhi Jiang, MSc

CONTACT

86 13692244182; jiangyingzhi@hec.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2022
• First Posted: October 19, 2022
• Study Start: March 3, 2023
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): May 30, 2028
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)