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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00446303
Other study ID # GFM aza05
Secondary ID
Status Terminated
Phase Phase 2
First received March 9, 2007
Last updated January 18, 2012
Start date July 2006
Est. completion date July 2010

Study information

Verified date June 2010
Source Groupe Francophone des Myelodysplasies
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

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)


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


Recruitment information / eligibility

Status Terminated
Enrollment 39
Est. completion date July 2010
Est. primary completion date July 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility 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

Study Design

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


Intervention

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.

Locations

Country Name City State
France CHU d'Amiens Amiens
France CHU Angers Angers
France CH d'Avignon Avignon
France CHU de Caen Caen
France Hopital d'Instruction des Armées Percy Clamart
France Hopital Henri Mondor Creteil
France CHU de Dijon Dijon
France CHU Albert Michallon Grenoble
France CHRU Hurriez Lille
France CHRU de Limoges Limoges
France Hopital Edouard Herriot Lyon
France Hopital Paoli Calmette Marseille
France Hopital Hotel Dieu Nantes
France Hopital Archet Nice
France Hopital Cochin Paris
France Hopital Saint Antoine Paris
France Hopital Saint Louis Paris
France Hopital Haut Leveque Pessac
France Hopital Jean-Bernard Poitiers
France CHRU de Reims Reims
France CHU Pontchaillou Rennes
France Hopital Hautepierre Strasbourg
France Hopital Purpan Toulouse
France CHU Brabois Vandoeuvre
France CH Versailles Versailles

Sponsors (2)

Lead Sponsor Collaborator
Groupe Francophone des Myelodysplasies Celgene Corporation

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reponse duration and cumulative incidence of relapses 1-24 months Yes
Secondary Toxicity according to WHO 1-24 months Yes
Secondary Overall survival Yes
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