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Clinical Trial Summary

A phase II multicentre trial of maintenance with Azacitidine in MDS patients achieving complete or partial remission (CR or PR) after intensive chemoterapy.

The primary objective is response duration (MDS or AML)


Clinical Trial Description

A academic multicentre study whose aims are to study the benefits of a maintenance therapy with 24 monthly courses af azacytidine in high-risk MDS patients, previously treated with intensive chemotherapy with obtention of a partial or complete response and not eligible for allogeneic transplantation ;


Study Design

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


Related Conditions & MeSH terms


NCT number NCT00446303
Study type Interventional
Source Groupe Francophone des Myelodysplasies
Contact
Status Terminated
Phase Phase 2
Start date July 2006
Completion date July 2010

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