A Phase II Study of Maintenance With Azacitidine in MDS Patients

Phase 2

Terminated

• Conditions: Leukemia, Myelocytic, Acute; Myelodysplastic Syndromes

• Registration Number: NCT00446303
• Lead Sponsor: Groupe Francophone des Myelodysplasies

Brief 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)

Detailed 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 Timeline

• Study Start: 2006-07
• Study First Submitted: 2007-03-09
• Study First Submitted QC: 2007-03-09
• Study First Posted: 2007-03-12
• Status Verified: 2010-06
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Last Update Submitted: 2012-01-18
• Last Update Posted: 2012-01-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 39

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Reponse duration and cumulative incidence of relapses	1-24 months

Secondary Outcome Measures

Name	Time	Method
Toxicity according to WHO	1-24 months
Overall survival

Trial Locations

Locations (25)

CHU de Caen; 🇫🇷 Caen, France

CHU d'Amiens; 🇫🇷 Amiens, France

Hopital d'Instruction des Armées Percy; 🇫🇷 Clamart, France

CHU Angers; 🇫🇷 Angers, France

CH d'Avignon; 🇫🇷 Avignon, France

Hopital Henri Mondor; 🇫🇷 Creteil, France

CHU Albert Michallon; 🇫🇷 Grenoble, France

CHU de Dijon; 🇫🇷 Dijon, France

CHRU Hurriez; 🇫🇷 Lille, France

CHRU de Limoges; 🇫🇷 Limoges, France

Hopital Paoli Calmette; 🇫🇷 Marseille, France

Hopital Edouard Herriot; 🇫🇷 Lyon, France

Hopital Archet; 🇫🇷 Nice, France

Hopital Hotel Dieu; 🇫🇷 Nantes, France

Hopital Saint Louis; 🇫🇷 Paris, France

Hopital Saint Antoine; 🇫🇷 Paris, France

Hopital Cochin; 🇫🇷 Paris, France

Hopital Jean-Bernard; 🇫🇷 Poitiers, France

CHU Brabois; 🇫🇷 Vandoeuvre, France

Hopital Purpan; 🇫🇷 Toulouse, France

Hopital Haut Leveque; 🇫🇷 Pessac, France

CHU Pontchaillou; 🇫🇷 Rennes, France

CHRU de Reims; 🇫🇷 Reims, France

Hopital Hautepierre; 🇫🇷 Strasbourg, France

CH Versailles; 🇫🇷 Versailles, France