drugset / Trial / NCT01149408

Decitabine Maintenance in Elderly Acute Myeloid Leukemia Patients

NCT01149408 ↗

Phase 1 Completed 3 enrolled University of Utah Eisai Inc. · collab
NaSingle-groupOpen-labelTreatment

Summary

The study aims at determining the feasibility of using maintenance Decitabine therapy following remission induction and consolidation in elderly Acute Myeloid Leukemia patients who are fit for aggressive therapy. Primary: Safety and tolerability of the decitabine regimen in the post remission state. Secondary: 1. Disease-free survival - To determine the one-year disease-free survival in elderly patients with acute myeloid leukemia (AML) in complete remission treated with Decitabine as post-consolidation maintenance therapy. 2. Overall survival

Timeline

Start
2011-02
Primary completion
2014-09
Completion
2014-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Decitabine Small molecule 20 mg/m2 Intravenous