Lymphoma Clinical Trial
Official title:
T-cel and B-cell Depletion in Allogeneic Peripheral Blood Stem Cell Transplantation by Using Immunomagnetic Negative and Positive Selection Procedures
T-cell and B-cell depletion in allogeneic peripheral blood stem cell transplantation by
using immunomagnetic negative and positive selection procedures
Background:
Removal of T-cells from the donor graft (T-cell depletion) offers the possibility for
prevention of GVHD and subsequently less transplant related morbidity and mortality after
allogeneic stem cell transplantation (SCT). There are several techniques to deplete T-cells
from the stem cell grafts e.g. physical, immunological and combined physical / immunological
separation methods. All these techniques result in a stem cell graft with sufficient CD34+
stem cells combined with an adequate depletion of T and B cells. CD34+ selected stem cell
grafts are very pure and do not contain any additional cell populations. In contrast,
CD3+/CD19+ depleted grafts still contain NK-cells, monocytes and dendritic cells that are
part of the innate immune system. Theoretically,the presence of these cells may positively
influence immunological reconstitution and the graft-versus-leukaemia (GVL) effect,
respectively, resulting in improved outcome after SCT
Objectives:
To evaluate the differences in immunological reconstitution, transplant related mortality,
disease-free survival and overall survival after T-cell depleted allogeneic SCT for
haematological malignancies using either immunomagnetic CD34+ selection or immunomagnetic
CD3+/CD19+ depletion using the CliniMACS system in approximately 270 consecutive patients.
Additionally in this study in 20 consecutive patients the kinetics of NK-cel reconstitution
and differences in NK-cell repertoire will be monitored. NK-cell mediated anti-tumor
reactivity will be monitored in patients transplanted with and without NK-cells in the stem
cell graft (CD3+/CD19+ depletion, versus CD34+ selection). Secondary objectives are to
evaluate the clinical relevance of minor histocompatibility-specific cytotoxic T-cell
responses for the GVL effect, the kinetics of NK-cell reconstitution and differences in
NK-cell repertoire using the different T-cell depletion protocols.
Design:
Single center prospective randomised phase III study
Population:
Patients eligible for allogeneic SCT according to the standard criteria of our institution
who will receive an allogeneic T- and B-cell depleted SCT with peripheral stem cells of an
HLA-identical sibling donor or an HLA-identical unrelated voluntary (VUD) donor.
Intervention:
T-cell depletion will be conducted using two different techniques: either immunomagnetic
CD34+ selection or immunomagnetic CD3+/CD19+ depletion.
Endpoints:
Primary endpoints are immunological reconstitution, relapse, disease free survival and
overall survival. Secondary endpoints: NK-cell reconstitution and NK-cell mediated
anti-tumour reactivity. Cytotoxic T-cell responses for the GVL effect.
Estimated efforts and risks for participating patients:
We don't expect any extra patient efforts or risks because T-cell depletion is a standard
procedure in our clinic for many years. There is extensive experience with immunological
T-cell depletion techniques. We hypothesize CD3+/CD19+ depletion will favour stem cell
transplant outcome. Immunological and molecular biological studies will be performed on
blood samples already obtained as part of the standard protocol.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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