• The primary aim of the present trial is to assess in a randomized fashion the benefit on standard graft-versus-host disease (GVHD) prophylaxis of the addition of ATG-Fresenius S ® in transplants from matched related donors (MRD) and of anti-CD20 rituximab in transplants from matched unrelated donors (MUD). Both safety and efficacy of the treatment will be assessed, in particular in respect to the clinical status of the patient, i.e. prevention of graft failure and chronic GvHD and of Ebstein Barr virus (EBV) viremia for MUD patients. The conditioning proposed combines myeloablative drugs with a favorable safety profile such as treosulfan, thiotepa (Tepadina®) and fludarabine with the intent to reduce the traditional immediate and late toxicity of busulfan and cyclophosphamide.
For patients transplanted from a MRD The primary end-point is the cumulative incidence of a combined end-point defined as the time from randomization to: * primary and secondary graft failure, * aGVHD II-IV, * cGVHD, * death, whichever occurs first. For patients transplanted from a MUD The primary end-point is the cumulative incidence of a combined end-point defined as the time from randomization to: * aGVHD II-IV, * EBV viremia, whichever occurs first.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
130
iv at a dose of 5 mg/kg within 8 hours on day -4,-3,-2 (total dose 15 mg/kg)
single infusion of200 mg/m2 on day -1
iv at a dose of 14 g/m² within 120 minutes on day -7, - 6, -5 (total dose of 42 g/m²)
iv at a dose of 30 mg/ m² within 30 minutes on day -7, -6, -5,-4,-3 after treosulfan
iv at a dose of 8 mg/kg on day - 3 divided into 2 infusions at 12 hrs intervals
iv at a dose of 3 mg/kg/day starting from day -1 and a dose adjustment will be done to obtain plasma levels of 150-250 ng/mL
iv at a dose of 15 mg/m2 on day +1, at a dose of 10 mg/m2 on day + 3 and + 6
iv at a dose of 15 mg/m2 on day +1, at a dose of 10 mg/m2 on day + 3 and + 6 and at a dose of 10 mg/m2 on day +11
University of Cagliari
Cagliari, Italy, Italy
ACTIVE_NOT_RECRUITINGSan Raffaele Scientific Institute
Milan, Italy, Italy
ACTIVE_NOT_RECRUITINGUniversity of Milano-Bicocca San Gerardo Hospital
Monza, Italy, Italy
ACTIVE_NOT_RECRUITINGBambino Gesù Hospital and Research Institute
Rome, Italy, Italy
RECRUITINGAcute graft-versus-host disease (aGVHD) II-IV and chronic GvHD
For patients transplanted from a MRD The cumulative incidence of a combined end-point defined as the time from randomization to: * primary and secondary graft failure, * aGVHD II-IV, * cGVHD, * death, whichever occurs first. For patients transplanted from a MUD The cumulative incidence of a combined end-point defined as the time from randomization to: * aGVHD II-IV, * EBV viremia, whichever occurs first.
Time frame: From date of randomization assessed up to 100 months
Chronic graft-versus-host disease (cGVHD)
The cumulative incidence and severity of cGVHD
Time frame: From date of randomization assessed up to 100 months
Treatment related mortality (TRM)
The incidence of TRM
Time frame: From date of randomization assessed up to 100 months
Overall survival (OS)
The overall survival probability
Time frame: From date of randomization assessed up to 100 months
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