drugset / Trial / NCT00656617

Phase II Study of Idarubicin, Cytarabine, and Vorinostat With High-Risk Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML)

NCT00656617

NaSingle-groupOpen-labelTreatment

Summary

The goal of this clinical research study is to find the highest safe dose of vorinostat that can be given in combination with idarubicin and ara-C for the treatment of AML and high-risk MDS. Once the highest safe dose is found, researchers will then try to learn if this combination treatment can help to control AML and high-risk MDS in newly diagnosed patients. The safety of this treatment combination will also be studied.

Timeline

Start
2008-04
Primary completion
2014-02
Completion
2014-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Cytarabine Small molecule 1500 mg/m2 Intravenous
Subject Idarubicin Small molecule 12 mg/m2 Intravenous
Subject Vorinostat Small molecule 500 mg Oral