drugset
drugset / Trial / NCT00569010

Phase I/II Study of 5-Azacytidine With Ara-C in Patients With Relapsed/Refractory Acute Myelogenous Leukemia (AML) or High Risk Myelodysplastic Syndrome (MDS)

NCT00569010 ↗

Phase 1/2 Completed 36 enrolled M.D. Anderson Cancer Center Celgene Corporation · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

The goal of this clinical research study is to find the highest tolerable dose of Azacytidine (5-azacytidine) combined with cytosine arabinoside (ara-C) for the treatment of patients with relapsed and/or refractory Acute Myeloid Leukemia (AML) or high-risk Myelodysplastic Syndrome (MDS). The safety and effectiveness of this treatment combination will also be studied.

Timeline

Start
2005-12
Primary completion
2009-10
Completion
2009-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Azacitidine Other / unclassified 37.5 mg/m2 Intravenous
Subject Azacitidine Other / unclassified 75 mg/m2 Intravenous
Subject Cytarabine Small molecule 100 mg/m2 Intravenous
Subject Cytarabine Small molecule 1 g Intravenous

Indications

acute myeloid leukemia myelodysplastic syndrome