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Azacitidine Combined to Epoetin Beta in International Prognostic Scoring System (IPSS) Low-risk and Intermediate-1 Myelodysplastic Syndrome (MDS) Patients, Resistant to Erythropoetin-stimulating Agents (ESA)

This study has been completed.
Sponsor:
Collaborators:
Celgene Corporation
Roche Pharma AG
Information provided by (Responsible Party):
Groupe Francophone des Myelodysplasies
ClinicalTrials.gov Identifier:
NCT01015352
First received: November 17, 2009
Last updated: March 18, 2014
Last verified: November 2009
  Purpose

The study is aimed to treat low-risk MDS patients,who are dependent on red-blood cell transfusion due to disease-related anemia, and who have a proven resistance towards treatment with erythropoetin-stimulating agents (ESA). The study randomizes patients to receive a treatment with the demethylating agent 5-azacytidine alone or in combination with an ESA. The study thus evaluates, if efficacy of 5-azacytidine, notably on the red-blood cell transfusion-dependence is comparable/inferior to a combination treatment with azacitidine and an ESA (that is if 5-azacytidine can overcome the resistance towards ESA). Being a phase II study, the study assesses, duration of erythroid response, overall survival and time to progression as well as toxicity.


Condition Intervention Phase
Myelodysplastic Syndromes
Drug: Azacitidine
Drug: Epoetin beta
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Azacitidine (Vidaza®) Combined to Epoetin Beta (NeoRecormon®) in IPSS Low-risk and Intermediate-1 MDS Patients, Resistant to ESA

Resource links provided by NLM:


Further study details as provided by Groupe Francophone des Myelodysplasies:

Primary Outcome Measures:
  • To determine the major erythroid response rate after 6 courses, assessed according to IWG 2000 criteria [ Time Frame: after 6 courses of treatment in the respective treatment arm ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Degree and duration of erythroid response (including red blood cell transfusion independence),overall survival and time to progression and toxicity [ Time Frame: after 4 and 6 months of treatment until the end of study ] [ Designated as safety issue: Yes ]

Enrollment: 98
Study Start Date: February 2009
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm A
Azacitidine 75mg/sqm SQ per day for 5 days every 28 days for 6 courses and 12 additional maintenance courses in responders.
Drug: Azacitidine
Azacitidine 75mg/sqm SQ per day for 5 days every 28 days
Other Name: Vidaza®
Active Comparator: Arm B

Azacitidine: 75mg/sqm SQ per day for 5 days every 28 days for 6 courses AND

Epoetin beta : 60000U weekly SQ injections (to be adapted according to Hb as described above)

12 additional maintenance courses are planned in responders

Drug: Azacitidine
Azacitidine 75mg/sqm SQ per day for 5 days every 28 days
Other Name: Vidaza®
Drug: Epoetin beta

Epoetin beta : 60000U weekly SQ injections

NeoRecormon®

Other Name: Epoetin beta : 60000U weekly SQ injections

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

MDS defined as

  • RCMD, RA with or without ring sideroblasts
  • RAEB 1, or CMML 1, if WBC < 13 G /l according to the WHO classification
  • with a low or int-1 IPSS score AND
  • primary or secondary resistance to epoetin alpha/ beta (> 60000 U/w) or darbepoetin (> 250ug/w), administered for at least 12 weeks
  • requirement of RBC transfusions > 4 U in the previous 8 weeks
  • Aged 18 years or more
  • Adequate contraception, if relevant
  • Negative pregnancy test if relevant
  • Written Informed consent
  • Ability to participate to a clinical trial and adhere to study procedures
  • Health insurance

Exclusion Criteria:

  • Therapy-related MDS (after chemo- or radiotherapy for a previous neoplasm or immune disorder)
  • Patients with a planned allogeneic bone marrow transplantation
  • Creatininemia >1.5 upper normal value or estimated Ccr less than 30ml/mn
  • ALAT and ASAT >2.5 upper normal value
  • Bilirubin >2N, except unconjugated hyperbilirubinemia due to MDS-related dyserythropoiesis
  • Heart failure NYHA > II
  • Known allergy to mannitol
  • Other tumor, unstable for the last three years, except in situ uterine carcinoma or basal skin tumor
  • ECOG > 2
  • Life expectancy less than 3 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01015352

Locations
France
CHU d'Amiens
Amiens, France, 80054
Hôpital Angers
Angers, France, 49033
Hôpital Avignon
Avignon, France, 84000
Hôpital de la Côte Basque
Bayonne, France, 64100
Hopital Avicenne
Bobigny, France, 93009
Hôpital Boulogne Sur Mer
Boulogne Sur Mer, France, 62321
Hopital Clémenceau
Caen, France, 14033
Hôpital le Bocage
Dijon, France, 21034
Hôpital kremlin Bicêtre
Kremlin Bicêtre, France, 94275
Hôpital Versailles
Le Chesnay, France, 78157
Hôpital Huriez
Lille, France, 59037
Hôpital Saint Vincent
Lille, France, 59020
Hôpital Limoges
Limoges, France, 87046
Hôpital Edouard Herriot
Lyon, France, 69437
Hôpital Paoli-Calmettes
Marseille, France, 13273
Hôpital Brabois
Nancy, France, 54511
Hôpital Hôtel Dieu
Nantes, France, 44035
Hôpital Archet1
Nice, France, 06202
Hôpital La Source
Orléans, France, 45067
Hôpital Saint Louis
Paris, France, 75475
Hôpital Lariboisière
Paris, France, 75475
Hôpital Saint Antoine
Paris, France, 75571
Hôpital Cochin
Paris, France, 75679
Hôpital Maréchal Joffre
Perpignan, France, 66046
Hôpital Jean-Bernard
Poitiers, France, 86021
Hôpital Reims
Reims, France, 51092
Hôpital Henri Becquerel
Rouen, France, 76038
Hôpital Hautepierre
Strasbourg, France, 67098
Hôpital Purpan
Toulouse, France, 31059
Sponsors and Collaborators
Groupe Francophone des Myelodysplasies
Celgene Corporation
Roche Pharma AG
Investigators
Principal Investigator: Simone Boehrer, MD Groupe Francophone des Myélodysplasies
Principal Investigator: Claude Gardin, MD Groupe Francophone des Myélodysplasies
  More Information

Additional Information:
No publications provided

Responsible Party: Groupe Francophone des Myelodysplasies
ClinicalTrials.gov Identifier: NCT01015352     History of Changes
Other Study ID Numbers: GFM-Aza-Epo-2008-01
Study First Received: November 17, 2009
Last Updated: March 18, 2014
Health Authority: France : ANSM agence nationale de sécurité du médicament et des produits de santé

Keywords provided by Groupe Francophone des Myelodysplasies:
Myelodysplastic Syndromes

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Preleukemia
Syndrome
Bone Marrow Diseases
Disease
Hematologic Diseases
Neoplasms
Pathologic Processes
Precancerous Conditions
Azacitidine
Epoetin alfa
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Hematinics
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014