NCT01058369

Exjade-Early-Trial

Early Treatment With Deferasirox (Exjade®) in Low Risk MDS - a Prospective Multicentre Single-arm Single-stage Phase II Study -

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: University of Erlangen-Nürnberg Medical School · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Study outline: Deferasirox (Exjade®) is regularly used in severe iron overload in order to avoid organ damage of liver, heart and other organs. It has been proposed, that iron overload may not only impose damage to other organs but also to the bone marrow and thus worsen hematopoietic insufficiency in patients with MDS. Patients presenting with low or INT-1 risk MDS with only mild iron overload will be treated with deferasirox in this study. It will be analyzed if hematological improvement can be observed during this treatment.

Conditions

• Myelodysplastic Syndromes

Interventions

Type	Name	Description
DRUG	Deferasirox (Novartis Pharma)	Treatment period 102 weeks. Starting dose 10mg/kg/day. Up to 30/mg/kg according to dose adjustment table as specified in the protocol

Timeline

• Start date: 2010-04-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2010-01-28
• Last updated: 2020-10-06
• Results posted: 2020-10-06

Locations

1 site across 1 country: Germany