Darbepoetin Alpha in Myelodysplastic Syndromes (MDS)

Myelodysplastic Syndromes Clinical Trial

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

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial 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 Design

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

Related Conditions & MeSH terms

• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

• NCT number: NCT00443339
• Study type: Interventional
• Source: Groupe Francophone des Myelodysplasies
• Contact: Charikleia KELAIDI, MD
• Phone: 0033148957051
• Email: charikleia .kelaidi@avc.aphp.fr
• Status: Recruiting
• Phase: Phase 2
• Start date: December 2006
• Completion date: July 2008