Feasibility and toxicity of peritransplantation immunosuppression with ATG, sirolimus, mycophenolate mofetil and rituximab in patients receiving mismatched allogeneic HCT after a reduced intensity conditioning regimen with fludarabine/treosulfan
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Conditioning with treosulfan 14 g/m2 day -6 to -4, fludarabine 30 mg/m2/24h day-6 to -2, ATG-Fresenius 20 mg/kg day -4 to -2, rituximab 500 mg/m2 day -1. Unmanipulated PBSC day 0. Postgrafting immunosuppression with mycophenolate mofetil (15 mg/kg TID) and sirolimus (2 mg QD).
Hematology/Oncology Medical Center University Hospital of Mainz
Mainz, Germany
Bone Marrow Transplantation Unit Medical Center University Hospital of Nuernberg
Nuremberg, Germany
Department of Hematology/Oncology Medical Center University Hospital of Tuebingen
Tübingen, Germany
BMT-Unit Deutsche Klinik für Diagnostik
Wiesbaden, Germany
Treatment related mortality
Time frame: 12 months after HCT
Treatment related mortality
Time frame: 24 months after HCT
Toxicity according CTC of protocol on day 100
Time frame: on day 100
Engraftment on day 100
Time frame: on day 100
Overall survival
Time frame: 12 months after HCT
Incidence of graft versus host disease
Time frame: 3 months after HCT
Incidence of infections
Time frame: 2 years after HCT
Immune reconstitution of CD3, CD3/CD4/CD8, CD56, CD19 cells
Time frame: 3 months after HCT
Overall survival
Time frame: 24 months after HCT
Incidence of graft versus host disease
Time frame: 6 months after HCT
Disease free survival
Time frame: 24 months after HCT
Disease response
Time frame: 12 months after HCT
Disease response
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Time frame: 24 months after HCT
Immune reconstitution of CD3, CD3/CD4/CD8, CD56, CD19 cells
Time frame: 6 months after HCT
Immune reconstitution of CD3, CD3/CD4/CD8, CD56, CD19 cells
Time frame: 12 months after HCT
Immune reconstitution of CD3, CD3/CD4/CD8, CD56, CD19 cells
Time frame: 24 months after HCT
Incidence of graft versus host disease
Time frame: 12 months after HCT
Incidence of graft versus host disease
Time frame: 24 months after HCT