Clinical trial NCT00446303: A Phase II Study of Maintenance With Azacitidine in MDS Patients
Official title: A Phase II Study of Maintenance With Azacitidine in MDS Patients Achieving Complete or Partial Remission (CR or PR) After Intensive Chemotherapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Leukemia, Myelocytic, Acute
Myelodysplastic Syndromes
Keywords: MDS
Myelodysplastic Syndromes
AML
Intensive chemotherapy
azacitidine
Lead sponsor: Groupe Francophone des Myelodysplasies
Sponsor class: OTHER
Collaborators: name: Celgene Corporation
First posted: 2007-03-12
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Reponse duration and cumulative incidence of relapses
timeFrame: 1-24 months
Secondary outcomes:
measure: Toxicity according to WHO
timeFrame: 1-24 months
measure: Overall survival
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU d'Amiens
city: Angers
country: France
facility: CHU Angers
city: Avignon
country: France
facility: CH d'Avignon
city: Caen
country: France
facility: CHU de Caen
city: Clamart
country: France
facility: Hopital d'Instruction des Armées Percy
city: Creteil
country: France
facility: Hopital Henri Mondor
city: Dijon
country: France
facility: CHU de Dijon
city: Grenoble
country: France
facility: CHU Albert Michallon
city: Lille
country: France
facility: CHRU Hurriez
city: Limoges
country: France
facility: CHRU de Limoges
city: Lyon
country: France
facility: Hopital Edouard Herriot
city: Marseille
country: France
facility: Hopital Paoli Calmette
city: Nantes
country: France
facility: Hopital Hotel Dieu
city: Nice
country: France
facility: Hopital Archet
city: Paris
country: France
facility: Hopital Saint Louis
city: Paris
country: France
facility: Hopital Saint Antoine
city: Paris
country: France
facility: Hopital Cochin
city: Pessac
country: France
facility: Hopital Haut Leveque
city: Poitiers
country: France
facility: Hopital Jean-Bernard
city: Reims
country: France
facility: CHRU de Reims
city: Rennes
country: France
facility: CHU Pontchaillou
city: Strasbourg
country: France
facility: Hopital Hautepierre
city: Toulouse
country: France
facility: Hopital Purpan
city: Vandoeuvre
country: France
facility: CHU Brabois
city: Versailles
country: France
facility: CH Versailles
Study officials:
affiliation: Groupe Francophone des Myelodysplasies
name: Claude GARDIN, MD
role: PRINCIPAL_INVESTIGATOR
References: