A Phase II Study of Maintenance With Azacitidine in MDS Patients

Study Overview
=================
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

Official Title
-----------------
A Phase II Study of Maintenance With Azacitidine in MDS Patients Achieving Complete or Partial Remission (CR or PR) After Intensive Chemotherapy

Conditions
-----------------
Leukemia, Myelocytic, Acute, Myelodysplastic Syndromes

Intervention / Treatment
-----------------
* Drug: Azacitidine


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reponse duration and cumulative incidence of relapses |  | 1-24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity according to WHO |  | 1-24 months | 
| Overall survival |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MDS, Myelodysplastic Syndromes, AML, Intensive chemotherapy, azacitidine