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A Phase II Study of Maintenance With Azacitidine in MDS Patients

NCT00446303 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2012-01-19

No results posted yet for this study

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)

Conditions

Interventions

DRUG

Azacitidine

Azacitidine 60mg/m2 /d for 5 days every 28 days, for 24 months (parallel study to the ongoing NMDSG study. Extension of maintenance in responders after 24 courses until relapse or death.

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • Groupe Francophone des Myelodysplasies

    lead OTHER

Principal Investigators

  • Claude GARDIN, MD · Groupe Francophone des Myelodysplasies

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • France

Study Locations

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Entities

Drugs
Diseases

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 NCT00446303 on ClinicalTrials.gov