CB transplantation: Myeloablative conditioning with post-transplant cyclophosphamide in patients receiving a matched CB transplant for hematological malignancies.
Study summary
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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* 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
* Diagnosis of 1 of the following hematological malignancies: Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome, high risk Acute Lymphoblastic Leukemia (ALL), Bi phenotypic/undifferentiated leukemia, Chronic Myeloid Leukemia resistant to TK inhibitors, Ph-neg Myeloproliferative Neoplasms, resistant/relapsing Non-Hodgkin's lymphoma ineligible for an autologous transplant.
Exclusion Criteria:
* Positive serologic markers for human immunodeficiency virus (HIV)
* Acute hepatitis B virus (HBV) or acute hepatitis C virus (HCV) infection
Primary outcome measure(s)
hematopoietic reconstitution — first post-transplant 1 day with neutrophil > 0.5x10^9/L and platelet > 20x10^9/L number of days for neutrophil (\> 0.5x10\^9/L) and platelet (\> 20x10\^9/L) engraftment
Trial sites (1)
Facility
City
Region
Status
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma
RM
Recruiting
More Fondazione Policlinico Universitario Agostino Gemelli IRCCS trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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