The Efficacy of Triple Regimen in Newly Diagnosed AML Patients With FLT3 Mutation
Recruiting
Phase 1
Phase 2
Interventional Study
FLT3 Gene Mutation
AML
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 14 and older
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 66 (estimated)
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China · Other
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About This Trial
The FMS tyrosine kinase 3 (FLT3) gene mutation occurs in 30% of newly diagnosed AML patients, leading to a higher relapse rate and mortality rate. In the past, multi-drug combination chemotherapy regimens had limited efficacy in newly diagnosed AML patients with FLT3 mutations, especially in those with FLT3-ITD. However, the FLT3 inhibitors greatly improved the survival of AML patients with FLT3 m…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. MDS/AML patients WHO meet AML and ICC definitions according to WHO (2022) or ICC standards (10%-20% of bone marrow naive cells) and have FLT3-TKD or ITD mutations detected by PCR or second-generation sequencing.
2. Age ≥15 years old, male or female.
3. The physical status ass…
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