Post-transplant iron overload
Conditions
Interventions
According to the treatment algorithm, maximum tolerated dose of deferasirox is defined. Initial dose of deferasirox is 5 mg/kg. Only if the adverse effect is limited to grade 0 or 1 for 4 weeks, the i
Sponsors
Kanto Study Group for Cell Therapy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Age >=18 year old (2)Over 6 month post transplantation (3)Serum ferritin > 1000 ng/ml and total red blood cell transfusion >=20 units (4)Hematological remission (5)Organ dysfunction Cr <1.0xULN, AST<3.0xULN and ALT<3.0xULN and T-bil<1.5xULN (6)In tolerable for phlebotomy (7)Chronic GVHD: none or mild (8)Possibility of survival over 6 months (9)PS: 0 or 1 (10)Informed consent
Exclusion criteria
Exclusion criteria: (1)No hematological remission (2)History of post-transplant iron chelating therapy (3)Chronic GVHD: moderate or severe (4)History of treatment for HBV or HCV hepatitis (5)Active infection (6)Uncontrollable complication (7)Active double cancer (8)Anafiraxis for deferasirox (9)Other factors judged inappropriate by doctors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose of deferasirox | — |
Secondary
| Measure | Time frame |
|---|---|
| (1)Medication course of deferasirox and maximum tolerated dose in a single case (2)Ratio of decrease of serum ferritin, changes of iron-related or biochemical marker (3)Development of adverse effects | — |
Countries
Japan
Contacts
Public ContactTakayoshi Tachibana
Kanto Study Group for Cell Therapy Trial Office
Outcome results
None listed