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A Phase II Study of Maintenance With Azacitidine in MDS Patients | Clinical Trials | Clareo Health

TERMINATEDPHASE2

A Phase II Study of Maintenance With Azacitidine in MDS Patients

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

NCT00446303•Groupe Francophone des Myelodysplasies

View on ClinicalTrials.gov

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

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

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

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

Locations (25)

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

Créteil, France

CHU de Dijon

Dijon, France

CHU Albert Michallon

Grenoble, France

CHRU Hurriez

Lille, France

CHRU de Limoges

Limoges, France

Key Dates

Start Date

July 1, 2006

Primary Completion Date

July 1, 2010

Completion Date

July 1, 2010

Last Updated

January 19, 2012

Enrollment

ACTUAL participants

Conditions

Leukemia, Myelocytic, AcuteMyelodysplastic Syndromes

Interventions

Azacitidine

DRUG

Phase Ib Study of CD33 FPBMC in Patients With MRD+ AML or MDS

NCT07270978

Acute Myeloid LeukemiaMyelodysplastic Syndromes+1 more

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RECRUITINGPHASE1

Venetoclax Basket Trial for High Risk Hematologic Malignancies

NCT05292664

Myelodysplastic Syndromes, de NovoMyelodysplastic Syndromes, Secondary+9 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 19, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Phase II Study of Maintenance With Azacitidine in MDS Patients

Inclusion Criteria

Exclusion Criteria

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