An Open-Label, Phase I/II Study of Two Different Schedules of Dasatinib (Sprycel) and Decitabine (Dacogen) Used in Combination for Patients With Accelerated or Blastic Phase Chronic Myelogenous Leukemia (Protocol CA180357)
Summary
The goal of this clinical research study is to learn if combining Sprycel (dasatinib) and Dacogen (decitabine) can help to control Chronic Myeloid Leukemia (CML). The dose level of decitabine will also be studied. Dasatinib is designed to block the protein that is responsible for chronic myeloid leukemia. Decitabine is designed to affect the mechanism that cells use to control the expression of certain genes, some of which are important in the progression of CML. This is an investigational study. Dasatinib is FDA approved and commercially available for the treatment of patients with certain types of CML. Decitabine is FDA approved for the treatment of patients with myelodysplastic syndrome. The combination of these drugs to treat CML is investigational. Up to 84 patients will take part in this study. All will be enrolled at MD Anderson.
Timeline
- Start
- 2012-06-12
- Primary completion
- 2019-09-24
- Completion
- 2019-09-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Decitabine | Small molecule | 10 mg/m2 | Intravenous |
| Subject | Decitabine | Small molecule | 20 mg/m2 | Intravenous |
| Subject | dasatinib anhydrous | Small molecule | 100 mg | Oral |
| Subject | dasatinib anhydrous | Small molecule | 140 mg | Oral |