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A Phase II Study of Intravenous Azacitidine Alone in Patients With Myelodysplastic Syndromes

2010-07-15 17:00:00 | BioPortfolio

Summary

The primary endpoint of this study is to estimate morphologic complete remission rate. Estimation of response rate is also a secondary objection.

Description

Primary Objective To estimate the rate of complete remission (CR) and partial remission (PR) after four cycles of therapy in patients with high risk myelodysplastic syndrome (MDS).

Secondary Objectives

The secondary objectives of the study are:

- To determine the rate of Hematologic improvement

- To determine the rate of transfusion independence

- To determine the time to disease progression to AML

- To determine the rate of cytogenetic response

- To determine the rate of overall survival

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Myelodysplastic Syndromes

Intervention

intravenous azacitidine

Location

Washington University School of Medicine
St. Louis
Missouri
United States
63110

Status

Completed

Source

Washington University School of Medicine

Results (where available)

View Results

Links

Published on BioPortfolio: 2010-07-15T17:00:00-0400

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