A Phase II Study of Maintenance With Azacitidine in MDS Patients

This study has been terminated.

Sponsor:

Collaborator:

Celgene Corporation

Information provided by (Responsible Party):

Groupe Francophone des Myelodysplasies

ClinicalTrials.gov Identifier:

NCT00446303

First received: March 9, 2007

Last updated: January 18, 2012

Last verified: June 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

March 9, 2007

Last Updated Date

January 18, 2012

Start Date ^ICMJE

July 2006

Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Reponse duration and cumulative incidence of relapses [ Time Frame: 1-24 months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

reponse duration and cumulative incidence of relapses

Change History

Complete list of historical versions of study NCT00446303 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Toxicity according to WHO [ Time Frame: 1-24 months ] [ Designated as safety issue: Yes ]
Overall survival [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

toxicity according to WHO
overall survival

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Phase II Study of Maintenance With Azacitidine in MDS Patients

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Leukemia, Myelocytic, Acute
Myelodysplastic Syndromes

Intervention ^ICMJE

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.

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

July 2010

Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT00446303

Other Study ID Numbers ^ICMJE

GFM aza05

Has Data Monitoring Committee

Yes

Responsible Party

Groupe Francophone des Myelodysplasies

Study Sponsor ^ICMJE

Groupe Francophone des Myelodysplasies

Collaborators ^ICMJE

Celgene Corporation

Investigators ^ICMJE

Principal Investigator:

Claude GARDIN, MD

Groupe Francophone des Myelodysplasies

Information Provided By

Groupe Francophone des Myelodysplasies

Verification Date

June 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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