Intensity-adjusted SAlvage chemotheraPy Plus FLT3-inHibitor Gilteritinib In RElapsed/refractory acute myeloid leukemia with mutated FLT3-ITD/TKD

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0006222

Enrollment

Registered

2021-06-07

Start date

2021-08-31

Completion date

Unknown

Last updated

2021-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : ? For intensive induction chemotherapy fit patients: FLAG-IDA + gilteritinib ? For intensive induction chemotherapy unfit patients: Low-dose cytarabine + gilteritinib • The usual dose schedule

? Gilteritinib 120mg daily on D6 for 3 weeks (D26). When LoDAC is the salvage regimen, the starting day will be day 11 for 3 weeks (D31). • If patients do not achieve CR but the investigator regards

the second cycle will be given at the discretion of the investigator if clinical benefit without remission is seen during the first cycle. The second induction therapy is given at least 4 weeks apart

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • 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.

Exclusion criteria

Exclusion criteria: • 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.

Design outcomes

Primary

Measure	Time frame
Complete remission (CR) rate in intention to treat group (ITTG)	—

Secondary

Measure	Time frame
composite CR (cCR) in per-protocol group (PPG),	—

Countries

Korea, Republic of

Contacts

Public Contacthawk kim

Gachon University Gil Medical Center

kimhawkmd@gmail.com+82-32-458-2746

Outcome results