Hematological Malignancies Clinical Trial
Official title:
An Observational Retrospective/Prospective Study of the Combination of Post-transplant High Dose Cyclophosphamide, Tacrolimus and Mycophenolate Mofetil for the Prevention of Acute Graft-versus-Host Disease in Patients Eligible to Allogeneic Hematopoietic Stem Cell Transplant Using Peripheral Blood Stem Cells (PBSC) From Unrelated or Related, HLA-identical or Partially Mismatched Donors
This observational study is proposed to observe the effect of high-dose, post-transplantation cyclophosphamide after a T cell-replete, HLA-matched PBSC graft from an HLA-identical or mismatched donor.
Allogeneic hematopoietic cell transplantation (HCT) remains the only curative approach for
many hematological malignancies. In allogeneic HCT the donor immune system through the donor
lymphocytes exerts both a beneficial and detrimental effect. Graft versus host disease (GVHD)
represents the major complication and cause of mortality of allogeneic HCT. The principal aim
that clinical transplant research must accomplish in the next years is to elaborate a
transplant strategy devoid of any GVHD but still capable of generating, through donor
lymphocytes, the graft versus tumor effect (GVT). The most used GVHD prophylaxis regimen
remains the association of a calcineurin-inhibitor (CNIs) for six months and four low-doses
of methotrexate (MTX) but the long length prophylaxis impacts on the process of
post-transplant immune reconstitution slowing it down and exposing patients to a high risk of
developing severe infections. The use of post-transplant cyclophosphamide looks the most
promising among the new approaches to GVHD control. The study design is an observational
retrospective/prospective Study in Patients Eligible to Allogeneic Hematopoietic Stem Cell
Transplant using Peripheral Blood Stem Cells (PBSC) from unrelated or related, HLA-identical
or partially mismatched donors. In case of unrelated donor, donor selection will be done
accordingly to Italian Bone Marrow Donor Registry (IBMDR). This protocol and the treatment
plan outlined below are limited to the plan or GVHD prevention.
The treatment plan for all patients including pre-conditioning therapy, TBI/chemotherapy,
central nervous system prophylaxis and other planned therapies, is described in the primary
transplant protocols which the patient has been assigned by the investigational site.
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