Evaluation of the safety and efficacy of 3 x 10, 3 x 12 or 3 x 14 g/m² Treosulfan resp., combined with 5 x 30 mg/m² fludarabine prior to allogeneic, hematopoietic stem cell transplantation of patients with hematological malignancies, but non-eligible to standard conditioning treatment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
56
10 g/m² i.v. infusion, day -6, -5, -4
12 g/m² i.v. infusion, day -6, -5, -4
14 g/m² i.v. infusion, day -6, -5, -4
Helsinki University Central Hospital
Helsinki, Finland
Charité University Hospital Berlin
Berlin, Germany
University Hospital Hamburg Eppendorf
Hamburg, Germany
5th Medical Clinic, Clinic North
Nuremberg, Germany
Safety - Evaluation of feasibility and tolerability of 3 x 10, 12 or 14 g/m² Treosulfan combined with 5 x 30 mg/m² fludarabine prior to allogeneic stem cell transplantation • frequency and severity of TRM until 6 months after transplantation
Time frame: 6 months
Efficacy - Evaluation of the proportion of relapse- and/or progression free patients six months after transplantation (using standard remission criteria)
Time frame: 6 months
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University Hospital Rostock
Rostock, Germany
Silesian Medical University
Katowice, Poland
Karolinska University Hospital & Karolinska Institute
Stockholm, Sweden