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A Phase II Study of Maintenance With Azacitidine in MDS Patients

NCT ID: NCT00446303

Last Updated: 2012-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2010-07-31

Brief Summary

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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)

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Detailed Description

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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

Conditions

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Leukemia, Myelocytic, Acute Myelodysplastic Syndromes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* MDS with int 2 or high IPSS score eitherRAEB 1 or 2 according to the WHO classification (see appendix 1) or CMML with WBC \< 13 109/l RAEB-T according to the FAB classification (see appendix 1) without t(8 ;21), inv 16 or t(16;16) AML secondary to MDS (sAML) with a confirmed MDS phase of at least 2 months with available bone marrow cytogenetics at diagnosis of AML

AND

in CR or PR according to IWG criteria (see appendix 3) after one or two courses of predefined intensive chemotherapy (see page 12) with available cytogenetics at evaluation of response Aged 18 years of age or more Written Informed consent Adequate Contraception, if relevant Negative pregnancy test if relevant. Patients not eligible for the azacitidine confirmatory trial (azacitidine " versus " conventional treatment ") or unwilling to participate to it

Exclusion Criteria

* AML secondary to myeloproliferative or MDS/MPD WHO subgroups except CMML with WBC\< 13 109/l
* Therapy related MDS (after chemo or radiotherapy for a previous neoplasm or immune disorder)
* Patients eligible for allogeneic bone marrow transplantation (with a identified donor)
* Liver and/or kidney failures prohibiting the use of azacitidine. Creatininemia \> 1.5 normal value ALAT and ASAT \> 3N
* Bilirubin \> 2 N, unless due to dyserythropoiesis
* Known hypersensitivity to azacitidine or mannitol
* Other tumor, unstable for the last three years, except in situ uterine carcinoma or basal skin tumor
* Uncontrolled infection,
* WHO Performance status \> 2
* Life expectancy less than 3 months
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Celgene Corporation

INDUSTRY

Sponsor Role collaborator

Groupe Francophone des Myelodysplasies

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Claude GARDIN, MD

Role: PRINCIPAL_INVESTIGATOR

Groupe Francophone des Myelodysplasies

Locations

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CHU d'Amiens

Amiens, , France

Site Status

CHU Angers

Angers, , France

Site Status

CH d'Avignon

Avignon, , France

Site Status

CHU de Caen

Caen, , France

Site Status

Hopital d'Instruction des Armées Percy

Clamart, , France

Site Status

Hopital Henri Mondor

Créteil, , France

Site Status

CHU de Dijon

Dijon, , France

Site Status

CHU Albert Michallon

Grenoble, , France

Site Status

CHRU Hurriez

Lille, , France

Site Status

CHRU de Limoges

Limoges, , France

Site Status

Hopital Edouard Herriot

Lyon, , France

Site Status

Hopital Paoli Calmette

Marseille, , France

Site Status

Hopital Hotel Dieu

Nantes, , France

Site Status

Hopital Archet

Nice, , France

Site Status

Hopital Saint Louis

Paris, , France

Site Status

Hopital Saint Antoine

Paris, , France

Site Status

Hopital Cochin

Paris, , France

Site Status

Hopital Haut Leveque

Pessac, , France

Site Status

Hopital Jean-Bernard

Poitiers, , France

Site Status

CHRU de Reims

Reims, , France

Site Status

CHU Pontchaillou

Rennes, , France

Site Status

Hopital Hautepierre

Strasbourg, , France

Site Status

Hopital Purpan

Toulouse, , France

Site Status

CHU Brabois

Vandœuvre-lès-Nancy, , France

Site Status

CH Versailles

Versailles, , France

Site Status

Countries

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France

Other Identifiers

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GFM aza05

Identifier Type: -

Identifier Source: org_study_id

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