• 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.
Phase:
Phase 2
Details
Lead Sponsor:
Franco Locatelli
Collaborators:
Fresenius AG medac GmbH University of Milano Bicocca