This is a Phase I/II multicenter study which aims to assess the toxicity profile of Romiplostim in patients with transfusion-dependent thrombocytopenia after allogeneic HSCT. A total of 24 patients with transfusion-dependent thrombocytopenia after allogeneic HSCT will be included. The main endpoint is the incidence and severity of adverse events.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Saint Louis hospital
Paris, Île-de-France Region, France
Adverse events
Incidence and severity of all adverse events
Time frame: 12 months
Dose of Romiplostim
Dose of Romiplostim required to reach a platelet count above 50 x 109/L in absence of platelet transfusion
Time frame: 12 months
Durable platelet response after transplant:
platelet count above 50 x 109/L on 8 consecutive weeks independent of platelet transfusions
Time frame: 12 months
Relapse rate
Time frame: 12 months
Graft versus host disease (GVHD)
Time frame: 12 months
Non relapse mortality rate
Time frame: 12 months
number of platelet transfusions
Time frame: 12 months
Overall number of bleeding events
Time frame: 12 months
platelet hematological improvements
Incidence and duration of platelet hematological improvements above 20 x 109/L and above 50 x 109/L , respectively
Time frame: 12 months
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