The purpose of this study is to determine whether the administration of a donor lymphocyte preparation depleted of functional host alloreactive T-cells (ATIR) after a T-cell depleted stem cell transplant from a related, haploidentical donor enhances survival by improving the immune effect against infections while preventing graft-versus-host disease .
Allogeneic stem cell transplantation is the treatment of choice for many patients with leukemia and other hematologic malignancies. However, a major limitation of this therapy is that for a significant number of patients no fully HLA-matched donor can be found. The application of partially HLA-matched (haploidentical) family donors, who are virtually always available, has some complications. If there is no T-cell add-back it increases the risk for life-threatening infections and disease relapse, while in case of T-cell add-back the risk for graft-versus-host disease is raised. Kiadis Pharma has developed a method to selectively deplete host alloreactive T-cells through photodynamic therapy, using TH9402 ex vivo. The donor lymphocyte preparation depleted of functional host alloreactive T-cells (ATIR) is administered to the patient 28-42 days after the stem cell transplant.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
40
Single intravenous infusion with 2x10E6 T-cells/kg
Ohio State University, Comprehesive Cancer Center
Columbus, Ohio, United States
Algemeen Ziekenhuis Sint-Jan
Bruges, Belgium
Université Libre de Bruxelles - Institute Jules Bordet
Brussels, Belgium
Universitair Ziekenhuis Gasthuisberg
Leuven, Belgium
University of Liege - CHU Sart Tilman
Liège, Belgium
HHSC, Henderson Hospital Site
Hamilton, Ontario, Canada
Ontario Cancer Institute / Princess Margaret Hospital
Toronto, Ontario, Canada
Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada
Universitätsklinikum Freiburg, Medizinische UNI-Klinik
Freiburg im Breisgau, Germany
Universitätsklinikums Schleswig-Holstein Campus Kiel
Kiel, Germany
...and 5 more locations
Transplant Related Mortality
TRM is defined as death due to causes other than disease relapse or progression, or other causes which are unrelated to the transplantation procedure (e.g. accident, suicide)
Time frame: 6, 12 and 24 months after the transplantation
Incidence and Severity Graft-versus-host Disease (GVHD)
GVHD was graded according to standard criteria as referred to in the reference module (Filipovich et al. 2005; Przepiorka et al. 1995).
Time frame: Up to 24 months after the transplantation
Progression Free Survival
Time frame: Up to 24 months after the transplantation
Incidence and Severity of Bacterial, Viral or Fungal Infection
Time frame: Up to 24 months after the transplantation
Immune Reconstitution
Time frame: Up to 24 months after the transplantation
Health Status (Including Quality of Life)
Time frame: Up to 24 months after the transplantation
Overall Survival
Time frame: 6, 12, and 24 months after the transplantation
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