drugset / Trial / NCT05024552
Vyxeos Plus Gilteritinib in Relapsed or Refractory, FLT3-Mutated AML
Phase 1
Recruiting
22 enrolled
H. Lee Moffitt Cancer Center and Research Institute
Jazz Pharmaceuticals · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
This study combines vyxeos and gilteritinib in patients with relapsed or refractory FLT3-mutated acute myeloid leukemia. Vyxeos and gilteritinib will be given as induction therapy. Those patients entering a complete remission or a complete remission with incomplete blood count recovery will be allowed to proceed to consolidation therapy with vyxeos and gilteritinib. Those patients who do not proceed to an allogeneic stem cell transplant for any reason are able to enter the maintenance phase of this trial using daily gilteritinib
Timeline
- Start
- 2022-02-25
- Primary completion
- 2027-02-15
- Completion
- 2027-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CPX-351 | Other / unclassified | 29 mg/m2 | Intravenous |
| Subject | CPX-351 | Other / unclassified | 44 mg/m2 | Intravenous |
| Subject | CPX-351 | Other / unclassified | 65 mg/m2 | Intravenous |
| Subject | CPX-351 | Other / unclassified | 100 mg/m2 | Intravenous |
| Subject | Gilteritinib | Small molecule | 80 mg | Oral |
| Subject | Gilteritinib | Small molecule | 120 mg | Oral |