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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Treatment period 102 weeks. Starting dose 10mg/kg/day. Up to 30/mg/kg according to dose adjustment table as specified in the protocol
Medizinische Klinik 5, Universitätsklinikum Erlangen
Erlangen, Bavaria, Germany
Fraction of Patients With Hematologic Improvement According to Modified IWG Criteria (Reduction of Transfusions and/or Increase in Hb, Improvement of Neutropenia and Thrombocytopenia)
Time frame: within two years
Evaluate the Safety and Tolerability Profile of Deferasirox in MDS Patients
Time frame: within two years
Effectiveness of Iron Depletion
Time frame: within two years
Correlation Between Hematological Improvement and Effectiveness of Iron Depletion
Time frame: two years
Development of Bone Marrow Morphology
Time frame: two years
Correlation Between Hematological Improvement and Pretreatment Parameters. Extension of This Analysis to MDS Patients on Deferasirox Within the Licensed Indication (More Severe Iron Overload)
Time frame: two years
Overall Survival
Time frame: within two years
AML-free Survival
Time frame: within two years
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