Lymphoma Clinical Trial
Official title:
Multi-center, Phase II Study to Assess the Safety and Efficacy of Haploidentical Bone Marrow Transplantation Using Reduced Intensity Conditioning(RIC)Regimen and Post-transplant Cyclophosphamide,in Patients With Poor Prognosis Lymphomas
Study to test feasibility and efficacy of T-replete Bone Marrow (BM), infused after a RIC regimen and post-transplantation Cyclophosphamide (Cy), in patients with poor prognosis lymphomas.
Allogeneic stem cell transplantation (ALLO) is the treatment of choice for many
hematological diseases. However, HLA identical donor (sibling or unrelated) is available for
50-60% of patients and alternative donors are needed. Haploidentical donors have been used
for many years, mostly after extensive T-cell depletion of peripheral stem cell, to avoid
Graft Versus Host Disease (GVHD). Recently, promising data have been reported with
haploidentical transplantation using T-replete bone marrow (BM) and high-dose
cyclophosphamide (Cy) post-transplantation. However, the conditioning regimen did not
contain drugs active against hemopathies, enhancing the relapse risk.
In this study, the investigators want to test the feasibility and efficacy of T-replete BM,
infused after a RIC regimen and post-transplantation Cy, in patients with poor prognosis
lymphoproliferative diseases.
The RIC regimen consisted of modified regimen used in different studies conducted in Italy
on behalf GITMO.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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