None listed
Conditions
Interventions
Drug : [Drug to be used]
Deferasirox, oral formulation
? Oral administration of deferasirox 10 mg/kg/day
Dosage is calculated and rounded off to the closest by combining 125mg, 250mg, 500mg, and 1000
Sponsors
Gachon University Gil Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Red blood cell transfusion-dependent anemia with low accumulation of iron - 50ng/ mL <serum ferritin=500ng/mL - Accumulated red blood cell transfusions=10 units - Red blood cell transfusion-dependent anemia (receiving more than 2 units of red blood cell transfusion within four months) - The causes of anemia include one of the followings: Aplastic anemia (idiopathic cytopenia of undetermined significance) (clonal cytopenia of undetermined significance) Idiopathic myelofibrosis - Blood disorders requiring long-term red blood cell transfusions - Aged 18 years and over - Obtaining the informed consent with signature and dates - ECOG<4 - Healthy liver and kidneys (AST, ALT, bilirubin, and creatinine levels below the normal upper limit by 2.5 times). - Those who did not achieve CR after the primary induction chemotherapy for the newly diagnosed, therapy naïve AML (if re-induction therapy is performed according to the preliminary plan for primary induction chemotherapy, it is considered that the first-line therapy is performed only.)
Exclusion criteria
Exclusion criteria: Iron-deficiency anemia (serum ferritin<50ng/mL) Acute leukemia Medication or treatment-induced anemia Myelodysplastic syndrome IPSS intermediate-2 or high Platelet count <50x109/L Progressive malignant tumor Patients to receive stem cell transplantation within six months Active infections Patients difficult to comply with treatment due to psychiatric or cognitive problems Hypersensitive to the medicine’s main ingredients or other components Creatinine clearance <60mL/min or serum creatinine level doubled from the normal upper limit based on age History of treatment with deferasirox Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption pregnancy women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum ferritin levels after the transfusion of 20 units of red blood cells | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety evaluation, profession-free survival (PFS), and overall survival (OS) in the pre-protocol group (PPG) and the safety group (SG) | — |
Countries
Korea, Republic of
Contacts
Public ContactSinhye Jang
Gachon University Gil Medical Center
Outcome results
None listed