Comparing Clifutinib to Salvage Chemotherapy for Relapsed FLT3-ITD AML
HEC73543 Versus Salvage Chemotherapy in Relapsed or Refractory FLT3-ITD Acute Myeloid Leukemia: a Multicenter, Open-label, Randomized Phase 3 Trial
This study is testing whether Clifutinib can help Chinese adults with relapsed FLT3-mutated acute myeloid leukemia feel better and live longer compared to standard chemotherapy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 324 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sunshine Lake Pharma Co., Ltd. Industry-sponsored |
| Drugs / interventions | chemotherapy, Clifutinib |
| Locations | 1 site (Hanzhou) |
| Trial ID | NCT05586074 on ClinicalTrials.gov |
What this trial studies
This Phase III clinical study evaluates the effectiveness of Clifutinib in treating Chinese patients with relapsed or refractory FLT3-mutated acute myeloid leukemia (AML) compared to standard salvage chemotherapy. Participants aged 18 and older will be randomized in a 2:1 ratio to receive either Clifutinib or a pre-selected salvage chemotherapy regimen. The study aims to assess overall survival and the rate of complete response or complete response with partial hematologic recovery. Following treatment, participants will undergo safety follow-ups and long-term monitoring.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with relapsed or refractory FLT3-mutated AML who have previously undergone first-line therapy.
Not a fit: Patients who have received prior treatment with other FLT3 inhibitors or those with AML that has relapsed after multiple lines of therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option that improves survival rates for patients with relapsed FLT3-mutated AML.
How similar studies have performed: Other studies have shown promising results with FLT3 inhibitors in AML, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hanzhou
- the First Affiliated Hospital,College of Medicine,Zhejiang University — Hanzhou, China (Recruiting)
Study contacts
- Principal investigator: Jie Jin, MD, PhD — First Affiliated Hospital of Zhejiang University
- Study coordinator: Yingzhi Jiang, MSc
- Email: jiangyingzhi@hec.cn
- Phone: 86 13692244182
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.