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Decitabine Maintenance in Elderly Acute Myeloid Leukemia Patients

NCT01149408 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2015-10-07

No results posted yet for this study

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

Conditions

Interventions

DRUG

Decitabine (Dacogen)

Decitabine; 20 mg/m2; 1 hour intravenous infusion; 1 -3 days (will be given on a 28-day cycle for up to 18 months)

Sponsors & Collaborators

Principal Investigators

  • Paul J Shami, MD · University of Utah

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01149408 on ClinicalTrials.gov