drugset / Trial / NCT01627041
Decitabine, Cytarabine, and Daunorubicin Hydrochloride in Treating Patients With Acute Myeloid Leukemia
RandomizedParallel-groupOpen-labelTreatment
Summary
This randomized phase II trial studies how well decitabine works when given together with daunorubicin hydrochloride and cytarabine in treating patients with acute myeloid leukemia. Drugs used in chemotherapy, such as decitabine, daunorubicin hydrochloride, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Decitabine may help daunorubicin hydrochloride and cytarabine kill more cancer cells by making them more sensitive to the drugs. It is not yet known whether low-dose decitabine is more effective than high-dose decitabine when giving together with daunorubicin hydrochloride and cytarabine in treating acute myeloid leukemia.
Timeline
- Start
- 2011-09-16
- Primary completion
- 2016-02-11
- Completion
- 2027-02-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cytarabine | Small molecule | — | Intravenous |
| Subject | Daunorubicin | Small molecule | — | Intravenous |
| Subject | Decitabine | Small molecule | — | Intravenous |
Indications
acute basophilic leukemia
acute myeloblastic leukemia with maturation
acute myeloblastic leukemia without maturation
acute myeloid leukemia and myelodysplastic syndromes related to alkylating agent
acute myeloid leukemia, t(9;11)(p21.3;q23.3)
acute myelomonocytic leukemia M4
adult acute monocytic leukemia