drugset / Trial / NCT01794702
Decitabine Followed by Clofarabine, Idarubicin, and Cytarabine in Acute Leukemia
SequentialOpen-labelTreatment
Summary
The goal of Phase I of this clinical research study is find the highest tolerable dose of clofarabine that can be given with decitabine, idarubicin, and cytarabine to patients with acute leukemia. The goal of Phase II of this study is to learn if decitabine followed by the combination of clofarabine, idarubicin, and cytarabine can help to control acute leukemia. The safety of this drug combination will also be studied. Decitabine and idarubicin are designed to damage the DNA (the genetic material of cells). This may cause cancer cells to die. Clofarabine is designed to interfere with the growth and development of cancer cells. Cytarabine is designed to insert itself into DNA and stop the DNA from repairing itself.
Timeline
- Start
- 2013-02-20
- Primary completion
- 2018-01-11
- Completion
- 2018-01-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Clofarabine | Other / unclassified | 15 mg/m2 | Intravenous |
| Subject | Cytarabine | Small molecule | 1 g | Intravenous |
| Subject | Decitabine | Small molecule | 20 mg/m2 | Intravenous |
| Subject | Idarubicin | Small molecule | 10 mg/m2 | Intravenous |