drugset / Trial / NCT00882102

Decitabine and Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (H-R MDS)

NCT00882102

Phase 2 Completed 43 enrolled M.D. Anderson Cancer Center Eisai Inc. · collab
NaSingle-groupOpen-labelTreatment

Summary

The goal of this clinical research study is to learn if 5-aza-2 deoxycytidine (decitabine) given in combination with Mylotarg (gemtuzumab ozogamicin) can help to control Acute myeloid leukemia (AML), high-risk myelodysplastic syndromes (MDS) or Myelofibrosis (MF). The safety of this drug combination will also be studied.

Timeline

Start
2009-04
Primary completion
2012-08
Completion
2012-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Decitabine Small molecule 20 mg/m2 Intravenous
Subject Gemtuzumab Ozogamicin Monoclonal antibody 3 mg/m2 Intravenous