E83.1
Conditions
Interventions
Group 1: Patients with chronic iron overload and a malignant haematological disease receive the iron chelator deferasirox as coated tablet once daily during conditioning therapy prior to allogeneic st
Sponsors
Universitätsklinikum Hamburg-Eppendorf, Klinik für Stammzelltransplantation
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: chronic iron overload due to red blood transfusions (Ferritin = 1000ng/ml), if a therapy with Deferoxamin is contraindicated or if inappropriate; Busulfan-containing conditioning therapy prior to allogenic stem cell transplantation
Exclusion criteria
Exclusion criteria: impaired kidney function (GFR < 60 ml/min), impaired liver function (= Child-Pugh B), concomitant therapy with drugs known as strong inductors of UGT (e.g. Phenytoin, Rifampicin, Phenobarbital, Ritonavir)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. labil plasma iron (total exposure and maximum value) measured on all days of the conditioning therapy and on day +4, +7 and +14 after allogenic stem cell transplantation 2. effect of Deferasirox on the pharmcokinetics of busulfan (therapeutic drug monitoring on the days of busulfan application) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Tolerability of deferasirox according to CTCAE criteria 2. Combined endpoint of infection rates (bacteremia defined as positive blood cultures, invasive fungal infections according to EORTC criteria) until day 28 and toxicities grade IV NCI (CTCAE) until day 28 (bilirubin elevation, mucositis, acute renal failure) | — |
Countries
Germany
Contacts
Public ContactClaudia Langebrake
Universitätsklinikum Hamburg-Eppendorf, Klinik für Stammzelltransplantation und Klinikapotheke
Outcome results
None listed