70
Participants
Start Date
November 21, 2014
Primary Completion Date
December 24, 2016
Study Completion Date
September 30, 2019
Treosulfan
"Treosulfan dose per day is to be calculated by using BSA:~One dose of Treosulfan per day on three consecutive days (day -6, day -5 and day -4) as intravenous (i.v.) infusion, given over 2 hours.~Two background conditioning regimens with Treosulfan are allowed: One regimen consists of a standardised Fludarabine-containing regimen (regimen A) and the other consists of an intensified regimen with Fludarabine and ThioTEPA (regimen B). The investigator decides for each individual patient whether to treat the patient with regimen A or with regimen B.~Treosulfan: i.v., BSA adapted: 10, 12 or 14 g/m²/day within 120 min to be administered prior to Fludarabine; Fludarabine: i.v., 30 mg/m2/day on days from -7 to -3 prior to HSCT; ThioTEPA (Regimen B): i.v., 2 x 5mg/kg/day on day -2."
Ospedale Infantile Regina Margherita Torino, Turin
University Clinic Hamburg-Eppendorf, Hamburg
Medical University Hannover, Hanover
University Clinic Düsseldorf, Düsseldorf
Universitätsklinikum Essen, Essen
University Clinic Münster, Münster
University Hospital Johann Wolfgang Goethe, Frankfurt
University Clinic Heidelberg, Heidelberg
University Clinic München, München
University Clinic Ulm, Ulm
University Clinic Erlangen-Nürnberg, Erlangen
University Clinic Regensburg, Regensburg
University Clinic Würzburg, Würzburg
St. Anna Children Hospital, Vienna
University Hospital Motol, Charles University, Prague, Prague
University Clinic Jena, Jena
Ospedale Bambino Gesu Roma, Rome
Bydgoszcz Medical University, Bydgoszcz
Kraków Medical University, Krakow
Lublin Medical University, Lublin
Wroclaw Medical University, Wroclaw
Birmingham Children's Hospital, Birmingham
Central Manchester University Hospital, Manchester
Sheffield Children's Hospital, Sheffield
Collaborators (2)
Celerion
INDUSTRY
Syneos Health
OTHER
medac GmbH
INDUSTRY