Comparing Clifutinib to Salvage Chemotherapy for Relapsed FLT3-ITD AML

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.