Iron chelation with Deferasirox under conditioning therapy prior to allogenic stem cell transplantatio

• Conditions: E83.1; Disorders of iron metabolism

• Registration Number: DRKS00015498
• Lead Sponsor: niversitätsklinikum Hamburg-Eppendorf, Klinik für Stammzelltransplantation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-10
• Study Completion: 2020-09-24
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 25

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

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)

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>2. effect of Deferasirox on the pharmcokinetics of busulfan (therapeutic drug monitoring on the days of busulfan application)

Secondary Outcome Measures

Name	Time	Method
1. Tolerability of deferasirox according to CTCAE criteria<br>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)