NCT05586074 HEC73543 Versus Salvage Chemotherapy in R/R FLT3-ITD AML
| NCT ID | NCT05586074 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Sunshine Lake Pharma Co., Ltd. |
| Condition | Leukemia, Acute Myeloid (AML) |
| Study Type | INTERVENTIONAL |
| Enrollment | 324 participants |
| Start Date | 2023-03-03 |
| Primary Completion | 2027-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 324 participants in total. It began in 2023-03-03 with a primary completion date of 2027-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Jie Jin, MD, PhD
PRINCIPAL INVESTIGATOR
First Affiliated Hospital of Zhejiang University
Frequently Asked Questions
Who can join the NCT05586074 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Leukemia, Acute Myeloid (AML). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05586074 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 324 participants.
Is NCT05586074 currently recruiting?
Yes, NCT05586074 is actively recruiting participants. Contact the research team at jiangyingzhi@hec.cn for enrollment information.
Where is the NCT05586074 trial being conducted?
This trial is being conducted at Hanzhou, China.
Who is sponsoring the NCT05586074 clinical trial?
NCT05586074 is sponsored by Sunshine Lake Pharma Co., Ltd.. The principal investigator is Jie Jin, MD, PhD at First Affiliated Hospital of Zhejiang University. The trial plans to enroll 324 participants.
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