Intensity-adjusted SAlvage chemotheraPy Plus FLT3-inHibitor Gilteritinib In RElapsed/refractory acute myeloid leukemia with mutated FLT3-ITD/TKD
- Conditions
- Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism
- Registration Number
- KCT0006222
- Lead Sponsor
- Gachon University Gil Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 26
•Relapsed or refractory mutated FLT3-ITD/TKD AML
•No prior exposure to Gilteritinib (prior exposure of other FLT3-inhibitors is permitted including quizartinib or midostaurin)
•Mean QTcF interval of ECG readings is 480 ms or shorter
•Written informed consent must be given.
•Patients must be 19 years of age or older.
•prior exposure to gilteritinib
•Patients who are not able to receive FLAG-Ida or LoDAC
•Acute promyelocytic leukemia with t(15;17) or PML/RARa rearrangement
•Patients with CNS involvement of leukemic blasts will not be excluded.
•Patients with extramedullary relapse(s) only will be excluded.
•Uncontrolled active infection
•Uncontrolled bleeding
•Patients who are pregnant or lactating.
•Patients having a psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complete remission (CR) rate in intention to treat group (ITTG)
- Secondary Outcome Measures
Name Time Method composite CR (cCR) in per-protocol group (PPG),