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

NCT ID: NCT05586074

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 324 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-03
• Study Completion Date: 2027-06-14

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.

Conditions

Leukemia, Acute Myeloid (AML)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Clifutinib

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.

Group Type: EXPERIMENTAL

Clifutinib

Intervention Type: DRUG

tablet, oral

Salvage Chemotherapy

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.

Group Type: ACTIVE_COMPARATOR

LoDAC

Intervention Type: DRUG

subcutaneous (SC) or intravenous (IV) injection

Azacitidine

Intervention Type: DRUG

SC or IV

Decitabine

Intervention Type: DRUG

IV

Ara-C±IDA

Intervention Type: DRUG

SC and IV

FLAG-IDA

Intervention Type: DRUG

SC and IV

Interventions

Clifutinib

tablet, oral

Intervention Type: DRUG

LoDAC

subcutaneous (SC) or intravenous (IV) injection

Intervention Type: DRUG

Azacitidine

SC or IV

Intervention Type: DRUG

Decitabine

IV

Intervention Type: DRUG

Ara-C±IDA

SC and IV

Intervention Type: DRUG

FLAG-IDA

SC and IV

Intervention Type: DRUG

Other Intervention Names

HEC73543; Low Dose Cytarabine; Cytarabine, Idarubicin; Granulocyte-Colony Stimulating Factor (G-CSF), Fludarabine, Cytarabine, Idarubicin

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sunshine Lake Pharma Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jie Jin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Zhejiang University

Locations

the First Affiliated Hospital,College of Medicine,Zhejiang University

Hanzhou, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Yingzhi Jiang, MSc

Role: CONTACT

jiangyingzhi@hec.cn

86 13692244182

Facility Contacts

Jie Jin, Doctor

Role: primary

jiej0503@163.com

0571-87236685

Other Identifiers

HEC73543-AML-301

Identifier Type: -

Identifier Source: org_study_id