A Phase II Study of Maintenance With Azacitidine in MDS Patients

Myelodysplastic Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00446303
• Other study ID #: GFM aza05
• Status: Terminated
• Phase: Phase 2
• First received: March 9, 2007
• Last updated: January 18, 2012
• Start date: July 2006
• Est. completion date: July 2010

Study information

• Verified date: June 2010
• Source: Groupe Francophone des Myelodysplasies
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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)

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Leukemia, Myelocytic, Acute
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Myelodysplastic Syndromes
• Preleukemia

Intervention

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.

Locations

Country	Name	City	State
France	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	Creteil
France	CHU de Dijon	Dijon
France	CHU Albert Michallon	Grenoble
France	CHRU Hurriez	Lille
France	CHRU de Limoges	Limoges
France	Hopital Edouard Herriot	Lyon
France	Hopital Paoli Calmette	Marseille
France	Hopital Hotel Dieu	Nantes
France	Hopital Archet	Nice
France	Hopital Cochin	Paris
France	Hopital Saint Antoine	Paris
France	Hopital Saint Louis	Paris
France	Hopital Haut Leveque	Pessac
France	Hopital Jean-Bernard	Poitiers
France	CHRU de Reims	Reims
France	CHU Pontchaillou	Rennes
France	Hopital Hautepierre	Strasbourg
France	Hopital Purpan	Toulouse
France	CHU Brabois	Vandoeuvre
France	CH Versailles	Versailles

Sponsors (2)

Lead Sponsor	Collaborator
Groupe Francophone des Myelodysplasies	Celgene Corporation

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reponse duration and cumulative incidence of relapses		1-24 months	Yes
Secondary	Toxicity according to WHO		1-24 months	Yes
Secondary	Overall survival			Yes