Cord Blood Transplantation, Hematological Malignancies
Conditions
Brief 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.
Detailed description
Study objectives. The primary objective is to evaluate neutrophil and platelet engraftment and day +100 CD4+ cell count in patients receiving matched CB unit transplant with a myeloablative conditioning regimen and a GVHD prophylaxis including post-transplant cyclophosphamide. Secondary objective is to estimate the incidence and severity of acute and chronic GVHD. Study endpoints. Primary endpoints are hematopoietic engraftment and day +100 CD4+ cell count. Secondary endpoints are acute and chronic GVHD
Interventions
PROCEDURECB transplantation
Myeloablative conditioning with post-transplant cyclophosphamide in patients receiving a matched CB transplant for hematological malignancies.
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| immune reconstitution | day 100 from transplant | number of CD4+cells at day 100 |
Countries
Italy
Contacts
Primary ContactAndrea Bacigalupo, Prof.
Backup ContactPatrizia Chiusolo, MD
Outcome results
None listed