Transplant-Related Hematologic Malignancy Clinical Trial
Official title:
Transplantation of Hematopoietic Progenitors From Haploidentical Donor With Selective in Vitro Depletion Allo-reactive Lymphocytes in Patient With High Risk Hematological Malignancies.
Therapeutic exploratory study to evaluate safety, open, nonrandomized, multicentre,
prospective, of cohort of patients who will receive different doses of allo-depleted
lymphocytes .
This project joins in this pioneering worldwide initiative with its own technology based on
the use of proteasome inhibitors in vitro, which advantages are, over other methods
described, the continuing viability of regulatory T cells and the use of a product to
generate allo-depletion that, contrary to those reported by other research groups, it does
not pose problems from the point of view of its use or toxicity as we employ a drug widely
used clinically by intravenous administration.
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
infusion.
Secondary objectives:
- 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
transplantation.
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.
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