drugset / Trial / NCT05756777
A Study of Gilteritinib in Combination With Ivosidenib or Enasidenib in People With Acute Myeloid Leukemia (AML)
Phase 1
Recruiting
18 enrolled
Memorial Sloan Kettering Cancer Center
Astellas Pharma US, Inc. · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The researchers are doing this study to see if the combination of gilteritinib with ivosidenib or enasidenib is a safe and effective treatment for people with relapsed/refractory AML with FLT3/IDH1 or FLT3/IDH2 gene mutations. The researchers will also look for the highest dose of the combination of gilteritinib with ivosidenib or enasidenib that causes few or mild side effects. When the highest safe dose is found, they will test that dose in new groups of participants.
Timeline
- Start
- 2023-10-25
- Primary completion
- 2027-04-21
- Completion
- 2027-04-21
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Enasidenib | Small molecule | 50 mg | — |
| Subject | Enasidenib | Small molecule | 100 mg | — |
| Subject | Gilteritinib | Small molecule | 80 mg | — |
| Subject | Gilteritinib | Small molecule | 120 mg | — |
| Subject | Ivosidenib | Small molecule | 250 mg | — |
| Subject | Ivosidenib | Small molecule | 500 mg | — |