Transfusion-induced iron overload
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Patients who have required two units or more red cell transfusion a month. (2) 500<=SF<=2,500 (3) aged 16 and over (4) Patients who had not received deferasirox. (5) Patients with an ECOG performance status of 0-1 (6) Patient who gave written informed consent before starting the screening test (by both a patient and a legal representative if a patient is minor).
Exclusion criteria
Exclusion criteria: (1) Patients with simultaneous multiple cancers. (2) Patients with severe liver or severe renal dysfunction. (3) Pregnant women or those with suspected pregnancy or nursing women (4) Patients with a psychiatric illness or symptoms that make it difficult to participate in the study. (5) Patients with history of hyper sensitivity to deferasirox. (6) Patients with history of hematopoietic stem cell transplantation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment continuation rate at 12 months after the initiation of iron chelation therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Changes of serum ferritin (2) Achievement rate of SF<1,000 (3) Achievement rate of SF<2,500 (4) Improvement of organ failure (heart, liver, pancreas) (5) Safety (6) Hematopoietic improvement (IWG2006 criteria) (7) total dose of transfusions (8) Concentration of EPO (9) Exposure of deferasirox | — |
Countries
Japan
Contacts
Osaka Saiseikai Nakatsu Hospital Division of Hematology