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

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)

Study Overview

• Status: Terminated
• Conditions: Myelodysplastic Syndromes; Leukemia, Myelocytic, Acute
• Intervention / Treatment: Drug: Azacitidine

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: Interventional
• Enrollment (Actual): 39
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80054
    • CHU d'Amiens
  • Angers, France, 49033
    • CHU Angers
  • Avignon, France, 84000
    • CH d'Avignon
  • Caen, France, 14033
    • CHU de Caen
  • Clamart, France, 92140
    • Hôpital d'Instruction des Armées PERCY
  • Creteil, France, 94000
    • Hopital Henri Mondor
  • Dijon, France, 21034
    • CHU de Dijon
  • Grenoble, France, 38043
    • CHU Albert Michallon
  • Lille, France, 59057
    • CHRU Hurriez
  • Limoges, France, 87046
    • CHRU de Limoges
  • Lyon, France, 69437
    • Hôpital Edouard Herriot
  • Marseille, France, 13273
    • Hopital Paoli Calmette
  • Nantes, France, 44093
    • Hôpital Hotel Dieu
  • Nice, France, 06202
    • Hôpital Archet
  • Paris, France, 75679
    • Hopital Cochin
  • Paris, France, 75475
    • Hôpital Saint Louis
  • Paris, France, 75571
    • Hopital Saint Antoine
  • Pessac, France, 33604
    • Hopital Haut Leveque
  • Poitiers, France, 86021
    • Hôpital Jean-Bernard
  • Reims, France, 51092
    • CHRU de Reims
  • Rennes, France, 35033
    • CHU Pontchaillou
  • Strasbourg, France, 67098
    • Hôpital Hautepierre
  • Toulouse, France, 31031
    • Hopital Purpan
  • Vandoeuvre, France, 54511
    • CHU Brabois
  • Versailles, France, 78000
    • CH Versailles

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Groupe Francophone des Myelodysplasies
• Collaborators: Celgene Corporation

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Primary Completion (ACTUAL): July 1, 2010
• Study Completion (ACTUAL): July 1, 2010

Study Registration Dates

• First Submitted: March 9, 2007
• First Submitted That Met QC Criteria: March 9, 2007
• First Posted (ESTIMATE): March 12, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): January 19, 2012
• Last Update Submitted That Met QC Criteria: January 18, 2012
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Keywords: AML; MDS; Myelodysplastic Syndromes; azacitidine; Intensive chemotherapy
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Precancerous Conditions; Leukemia; Myelodysplastic Syndromes; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Preleukemia; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Azacitidine
• Other Study ID Numbers: GFM aza05