drugset / Trial / NCT04209725
A Study of CPX-351 (Vyxeos™) With Quizartinib for the Treatment of FLT3-ITD Mutation-Positive Acute Myeloid Leukemia
NaSingle-groupOpen-labelTreatment
Summary
This is a research study to be done at multiple sites in participants with advanced acute myeloid leukemia (AML) that have a mutation in Fms-like tyrosine kinase-3 internal tandem duplications (FLT3-ITD). This study is to learn more about an investigational drug, quizartinib, being tested with the anti-cancer medicine CPX-351 (also called Vyxeos™), which is approved and widely used to treat AML. The purpose of this study is to assess the safety, tolerability and survival of patients receiving the combination of CPX-351 and quizartinib.
Timeline
- Start
- 2020-06-03
- Primary completion
- 2021-04-20
- Completion
- 2021-04-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cytarabine | Small molecule | 100 mg/m2 | Intravenous |
| Subject | Daunorubicin | Small molecule | 44 mg/m2 | Intravenous |
| Subject | Quizartinib | Small molecule | 30 mg | Oral |