Darbepoetin Alpha in Myelodysplastic Syndromes (MDS)

May 15, 2007 updated by: Groupe Francophone des Myelodysplasies

A Phase II Study of Darbepoetin Alpha in Myelodysplastic Syndromes (MSD)

This is an evaluation of the effectiveness of darbepoetin alpha in treating anemia of MDS patients with an International Prognostic Scoring System (IPSS) score of low or intermediate 1.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Inclusion of MDS with IPSS low or int-1 and hemoglobin < 10/dL.

Study drug: Darbepoetin alfa (Aranesp) 500 microg every two weeks subcutaneously during 12 weeks, combined to filgrastim 300 microg twice weekly for an additional 12 weeks in non responders.

Response will be evaluated at 12 weeks. Patients with major or minor erythroid response (HI-E major or minor according to IWG 2000 criteria) will be continued on Aranesp. In non-responders, an additional 12 weeks of Aranesp at the same dosing, combined to Filgrastim (300 ug twice weekly, then adjusted to maintain WBC between 5000 and 10000/mm3) will be proposed. In case of response, the treatment will be continued for a total duration of 24 months. If Hb level reaches levels > 13 g/dl at any time, Aranesp should be discontinued until Hb levels are less than 12 g/dl. Aranesp should then be resumed at 500 µg/injection every 3 weeks. Intervals between injections should be further increased by one week every time they lead to Hb levels > 13 g/dl. The purpose of this dose adjustment is to reach the Aranesp schedule allowing a maintenance Hb level between 11 and 12 g/dl.

Study Type

Interventional

Enrollment (Anticipated)

99

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 800054
      • Angers, France, 43033
        • Recruiting
        • CHU d'Angers
        • Contact:
      • Avignon, France, 84000
        • Recruiting
        • CHU d'Avignon
        • Contact:
      • Bayonne, France, 64 100
        • Recruiting
        • CH de la Côte Basque
        • Contact:
      • Brest, France, 29 609
        • Recruiting
        • Chu de Brest - Hôpital Morvan
        • Contact:
      • Caen, France, 14033
        • Recruiting
        • CHU de Caen
        • Contact:
        • Principal Investigator:
          • CHEZE, MD
      • Clamart, France, 92140
      • Créteil, France, 94010
      • Dijon, France, 21034
        • Recruiting
        • CHU de Dijon
        • Contact:
          • Denis CAILLOT
          • Phone Number: 0033380293645
        • Sub-Investigator:
          • BERGER, MD
        • Sub-Investigator:
          • BASTIE, MD
        • Sub-Investigator:
          • CASANOVAS, MD
        • Sub-Investigator:
          • SOLARY, Professor
      • Grenoble, France, 38043
        • Recruiting
        • CHU Albert Michallon
        • Contact:
        • Principal Investigator:
          • CAHN, Professor
      • Lille, France, 59057
        • Recruiting
        • CHRU Hurriez
        • Contact:
        • Principal Investigator:
          • QUESNEL, Professor
      • Limoges, France, 87046
        • Recruiting
        • CHRU Limoges
        • Contact:
        • Sub-Investigator:
          • Marie-Pierre CHAURY, Doctor
      • Lyon, France, 69437
        • Recruiting
        • Hôpital Edouard Herriot
        • Contact:
        • Sub-Investigator:
          • MICHALLET, Professor
        • Sub-Investigator:
          • TRONCY, MD
        • Principal Investigator:
          • CHELGHOUM, MD
      • Marseille, France, 13273
        • Recruiting
        • Hopital Paoli Calmette
        • Contact:
        • Principal Investigator:
          • VEY, MD
        • Sub-Investigator:
          • CHARBONNIER, MD
        • Sub-Investigator:
          • GASTAUT, Professor
        • Sub-Investigator:
          • BOUABDALLAH, MD
        • Sub-Investigator:
          • REY, MD
        • Sub-Investigator:
          • STOPPA, MD
      • Nantes, France, 44093
        • Recruiting
        • Hôpital Hotel Dieu
        • Contact:
        • Principal Investigator:
          • HAROUSSEAU, Professor
      • Nice, France, 06202
        • Recruiting
        • CHU Archet
        • Contact:
          • Laurence LEGROS, DOCTOR
          • Phone Number: 0033492035844
          • Email: legros@nice.fr
      • Paris, France, 75181
        • Recruiting
        • Hôpital Hotel Dieu
        • Contact:
        • Sub-Investigator:
          • Zora MARJANOVIC, Doctor
        • Sub-Investigator:
          • Anne VEKHOFF, Doctor
      • Paris, France, 75475
      • Paris, France, 75571
        • Recruiting
        • Hôpital Saint Antoine
        • Contact:
        • Principal Investigator:
          • ISNARD, MD
        • Sub-Investigator:
          • FOUILLARD, MD
        • Sub-Investigator:
          • LEMONNIER, MD
        • Sub-Investigator:
          • LAPORTE, MD
        • Sub-Investigator:
          • GARDERET, MD
        • Sub-Investigator:
          • COPPO, MD
        • Sub-Investigator:
          • GORIN, Professor
        • Sub-Investigator:
          • RAFFOUX, MD
      • Paris, France, 75679
        • Recruiting
        • Hopital Cochin
        • Contact:
        • Principal Investigator:
          • DREYFUS, Professor
      • Poitiers, France, 86021
        • Recruiting
        • Hôpital Jean-Bernard
        • Contact:
        • Principal Investigator:
          • GUILHOT, Profesor
        • Sub-Investigator:
          • ROY, MD
      • Reims, France, 51092
        • Recruiting
        • CHU Robert Debré
        • Contact:
        • Sub-Investigator:
          • Brigitte KOLB, Doctor
      • Rennes, France, 35033
        • Recruiting
        • CHU Pontchaillou
        • Contact:
        • Principal Investigator:
          • ESCOFFRE-BARBE, MD
        • Sub-Investigator:
          • DAURIAC, MD
        • Sub-Investigator:
          • BERNARD, MD
        • Sub-Investigator:
          • LAMY, MD
        • Sub-Investigator:
          • NIMUBONA, MD
      • Rouen, France, 76038
      • Strasbourg, France, 67098
        • Recruiting
        • Hôpital Hautepierre
        • Contact:
        • Principal Investigator:
          • AME, MD
      • Toulouse, France, 31031
        • Recruiting
        • Hopital Purpan
        • Contact:
        • Principal Investigator:
          • LAURENT, Professor
      • Tours, France, 37044
        • Recruiting
        • Hôpital Bretonneau
        • Contact:
      • Vandoeuvre les Nancy, France, 54511
        • Recruiting
        • CHU Nancy-Brabois
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • MDS of the following subtypes:

    • RA, RAS, RAEB with marrow blasts < 10% (according to FAB),
    • RA, RARS, RCMD, RAEB 1, CMML 1 with ≤ 10% WBC counts < 13000/mm3 (according to WHO classification)
  • Anemia, defined by Hb < 10 g/dl or RBC transfusion requirement in the absence of other causes of anemia (especially renal failure, iron, or folate deficiency)
  • IPSS ≤ 1(ie IPSS low or intermediate 1)
  • EPO level < 500 UI/L
  • Ability to perform physical tests of exercise tolerance
  • No renal failure (creatinine ≤ 120% normal upper value for the center)
  • No underlying severe condition
  • ECOG performance status score of 0, 1, or 2
  • Must be 18 years of age or older at the time of screening
  • Written informed consent

Exclusion Criteria:

  • Therapy related MDS
  • MDS with IPSS > 1 (int 2 or high score)
  • Chronic myelomonocytic leukemia with > 10% marrow blasts or WBC > 13000/mm3
  • Uncontrolled systemic hypertension
  • Cardiac condition: uncontrolled angina, congestive heart failure, or uncontrolled cardiac arrhythmia
  • Creatinine level > 120% upper normal value for the center.
  • Clinically significant systemic infection or chronic inflammatory disease (eg, rheumatoid arthritis) present at the time of screening
  • Serum folate ≤ 2.0 ng/mL or vitamin B12 ≤ 200 pg/mL (anemia related to nutritional deficiencies)
  • Other causes of anemia (eg, hemolysis, bleeding, sickle cell anemia, renal disease)
  • Pregnant (ie, positive βhCG test) or breast feeding female subjects
  • Women of childbearing potential and not using adequate contraceptives
  • Known positive antibody response to an erythropoietic growth factor
  • Known hypersensitivity to darbepoetin alpha or any of its excipients, or to recombinant erythropoietins
  • Patient unable to understand the protocol or to be adequately followed up.
  • History of seizures
  • Previous history of thrombotic events
  • Concomitant treatment with thalidomide

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Erythroid response at 12 weeks according to IWG 2000 (major and minor hematologic improvement) and IWG 2006 criteria

Secondary Outcome Measures

Outcome Measure
Overall survival
Tolerability and safety of darbepoetin alpha
Rate of progression to more severe MDS, with higher IPSS (int 2 or high), or to AML during the treatment and follow-up periods
Quality of life during the study, using the FACT-An and SF36 questionnaires by comparison to pre-treatment values
Overall physical performance as measured by VO2max, 6 minute walk test and the "short physical performance battery" test

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Francophone des Myelodysplasies

Investigators

  • Principal Investigator: Charikleia KELAIDI, MD, Groupe Francophone des Myelodysplasies

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion

December 7, 2022

Study Completion (Anticipated)

July 1, 2008

Study Registration Dates

First Submitted

March 4, 2007

First Submitted That Met QC Criteria

March 4, 2007

First Posted (Estimate)

March 6, 2007

Study Record Updates

Last Update Posted (Estimate)

May 17, 2007

Last Update Submitted That Met QC Criteria

May 15, 2007

Last Verified

March 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GFM-DAR500-2006-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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