About this trial
Despite anti-thymocyte globulin has a mainstay role in preventing GvHD (and non-relapse mortality) in CB transplantation, it also induces delayed immune recovery, increased risk of cytomegalovirus and Epstein-Barr virus reactivation, post-transplant lymphoproliferative diseases, overall accounting for increased transplant-related mortality and/or increased relapse incidence. All these findings support the use of alternative approaches for in vivo T cell depletion in the setting of CB transplantation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age: ≥ 18 ≤ 75 years old
CB unit transplantation (TNC> 2,0 x10^7/kg and > 4/6 loci HLA matched)
Myeloablative conditioning regimen consisting of either Thiotepa/ Busulfan/ Fludarabine or TBI/ Fludarabine
GVHD prophylaxis including PT-Cy (30 mg/kg or more on days + 3and +5) CSA and MMF
Disqualifiers
Positive serologic markers for human immunodeficiency virus (HIV)
Acute hepatitis B virus (HBV) or acute hepatitis C virus (HCV) infection
Trial population
Patients with no matched (\<7/8 HLA loci) sibling or unrelated donor, candidate to receive a transplant of a matched CB unit (TNC\> 2,0 x10\^7/kg and \> 4/6 loci HLA)
Trial design
Case-only
Prospective
Treatments tested in this trial
CB transplantation
Procedure/SurgeryMyeloablative conditioning with post-transplant cyclophosphamide in patients receiving a matched CB transplant for hematological malignancies.
Treatment groups
Trial outcomes
Primary outcomes
hematopoietic reconstitution
number of days for neutrophil (\> 0.5x10\^9/L) and platelet (\> 20x10\^9/L) engraftment
Secondary outcomes
immune reconstitution
number of CD4+cells at day 100
Sponsors and contacts
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