Trial of GVHD Prophylasxis With PTCy or Thymoglobulin in Unrelated SCT
Status:
Terminated
Trial end date:
2019-04-03
Target enrollment:
Participant gender:
Summary
Purpose There is a growing evidence of high efficacy of post-transplantation cyclophocphomide
(PTCy)-based GVHD prophylaxis in haploidentical and matched related and unrelated bone marrow
transplantation. There is limitted, but growing data on safety and efficacy of this
prophylaxis in unrelated and peripheral blood stem cell transplantations. Use of PTCy in
chronic myeloproliferative neoplasms and myelodisplatic syndrome is of particular interest.
On the one hand, PTCy could reduce the incidence of chronic GVHD and long-term bormidity. On
the other hand, there is a concern, that PTCy can increase the incidence of graft failures in
this group of patients. Currently published data indicate that low-dose Thymoglobulin-based
prophylaxis is the most promissing compatitor in terms of acute and chronic GVHD control. So
there is a rationale to randomize Thymoglobulin and PTCy as GVHD prophilaxis. Pre-transplant
assesment of moratlity (PAM)-index will be used as the strata for randomization, as it is the
paramter that takes into account the most important factors effecting survival. The
conditioning regimen and the other two components of GVHD prophylaxis (mycophenolate mofetil
and tacrolimus) will be identical in the two arms of the study.