A Phase II Multicentre, Randomized, Controlled Open-label Study on the Use of Anti-thymocyte Globulin and Rituximab for Immunomodulation of Graft-versus-host Disease in Allogeneic Matched Transplants for Non Malignancies

NCT01810926 Phase 2 UNKNOWN

• 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.

Details

Lead sponsor	Franco Locatelli
Phase	Phase 2
Status	UNKNOWN
Enrolment	130
Start date	2011-09
Completion	2016-10

Conditions

• Graft Versus Host Disease

Interventions

• polyclonal antibody
• Rituximab
• Treosulfan
• Fludarabine
• Thiotepa
• Cyclosporine A
• Methotrexate
• Methotrexate

Primary outcomes

• Acute graft-versus-host disease (aGVHD) II-IV and chronic GvHD — From date of randomization assessed up to 100 months
  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.

Countries

Italy