Transplantation of Hematopoietic Progenitors From Haploidentical Donor With Selective in Vitro Depletion Allo-reactive Lymphocytes in Patient With High Risk Hematological Malignancies.
The main objective of the study is to determine the safety of transplantation of
hematopoietic progenitors from haploidentical donor with in vitro allo-depleted lymphocyte
- To assess the immune reconstitution pre and post-infusion of allo-depleted lymphocytes.
- To analyze the incidence of infections (CMV and aspergillus) post-transplant.
- To analyze the impact of acute and chronic graft-versus-host disease (GVHD).
- To optimize the dose of allo-depleted lymphocytes to reconstitute an immune response
against pathogens without causing GVHD.
- To assess the rate of graft and myeloid and platelet engraftment time.
- To assess the rate of relapses, event-free survival and overall survival. It is hoped
to recruit 20 clinically evaluable patients for safety purpose.
The inclusion period is not more than 2 ½ years. Study duration shall not exceed three years
from the inclusion of the first patient. The minimum follow-up of patients is 6 months after
The first 5 patients (group 0) will receive haploidentical transplantation of hematopoietic
progenitors without subsequent infusion of allo-depleted lymphocytes and then in cohorts of
3 patients, infuse +4 post-transplant day at doses of: 1x105 cluster of differentiation 3
(CD3)/kg(group 1), 3x105 CD3/kg (group 2), 5x105 CD3 / kg (group 3), 1x106 CD3/kg (group 4)
and 3x106 CD3/kg (group 5).
Donor: it is performed one leukapheresis at least 30 days (4 weeks) prior to the scheduled
progenitors infusion (day 0), in order to obtain effector T cells.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of adverse events and serious adverse events after allo-depleted lymphocyte infusion in vitro.
Jose-Antonio Perez-Simón, MD, PhD
University Hospital Virgen del Rocío
Spain: Ethics Committee