Secondary hemochromotosis adJustment in patients with transfusion-dependent Anemia by early administration of low dose deferasirox
- Conditions
- Diseases of the blood and blood -forming organs and certain disorders involving the immune mechanism
- Registration Number
- KCT0003715
- Lead Sponsor
- Gachon University Gil Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 103
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.)
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Serum ferritin levels after the transfusion of 20 units of red blood cells
- Secondary Outcome Measures
Name Time Method Safety evaluation, profession-free survival (PFS), and overall survival (OS) in the pre-protocol group (PPG) and the safety group (SG)