Phase I of Infusion of Selected Donor NK Cells After HLA Identical Allogeneic Stem Cell Transplantation Prepared With Reduced Intensity Conditioning - DLI-NK/IPC 2012-003
In the mid 90's, it has been shown that donor lymphocyte infusions (DLI), when given for
Chronic Myelocytic Leukemia (CML) that has relapsed after conventional allogeneic stem cell
transplantation (SCT), result in a high incidence of durable cytogenetic and molecular
remissions. However, regular documented effects are the occurrence of secondary aplasia
and/or graft-versus-host disease (GVHD) including the post RIC situation. These effects are
related to the high content of cytotoxic T cells in the DLI. Attempts to deplete CD8+
T-cells from DLI have been conducted with promising results but are not totally
satisfactory.
More recently the infusion of r-IL2 ex-vivo activated autologous or allogeneic NK-selected
cells have been studied and the safety established in patients presenting various
malignancies.
Indeed, NK are thoroughly characterized in terms of genotype, phenotype and function.
Although a handful of clinical-grade reagents and devices exist that give access to the
human NK cell compartment, an immuno-selection device exists that allows for the selection
of NK cells from various types of hematopoietic cell collections in view of clinical
applications: the process produces CD3-/CD56+ cells in two steps and have been used in the
previous experiences.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Occurence of grade 3-4 toxicity within 30 days of NK cells infusion
To establish the safety of donor NK cells infusion after HLA matched allogeneic transplant prepared by RIC.
day 30
Yes
BLAISE Didier, MD PhD
Principal Investigator
Institut Paoli-Calmettes
France: Agence Nationale de Sécurité du Médicament et des produits de santé
DLI-NK/IPC 2012-003
NCT01853358
April 2013
April 2016
Name | Location |
---|