drugset / Trial / NCT05330377
GM-CLAG in Relapsed/Refractory FLT3-mutated AML
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the dose-limiting toxicities (DLT) and define the maximum tolerated dose (MTD) and the recommended phase II study dose of gilteritinib when combined with mitoxantrone, cladribine, cytarabine and filgrastim (GM-CLAG) in participants with FLT3- mutated relapsed or refractory (R/R) acute myeloid leukemia (AML).
Timeline
- Start
- 2023-03
- Primary completion
- 2027-05-30
- Completion
- 2032-05-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gilteritinib | Small molecule | 40 mg | Oral |
| Subject | Gilteritinib | Small molecule | 80 mg | Oral |
| Subject | Gilteritinib | Small molecule | 120 mg | Oral |
| Background | Cladribine | Small molecule | 5 mg/m2 | Intravenous |
| Background | Cytarabine | Small molecule | 2000 mg/m2 | Intravenous |
| Background | Mitoxantrone | Small molecule | 10 mg/m2 | Intravenous |
| Background | filgrastim | Protein / enzyme biologic | 300 ug | Subcutaneous |