An Open-label, Uncontrolled, Multicenter, Multinational Study on the Efficacy and Safety of Administration of Donor Lymphocytes Depleted of Alloreactive T-cells (ATIR), Through the Use of TH9402 and Light Treatment in an ex Vivo Process, in Patients Receiving a CD34-selected Peripheral Blood Stem Cell Graft From a Related, Haploidentical Donor
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Transplant related mortality
6 and 12 months after the transplantation
No
Stephan Mielke, MD
Study Chair
Julius Maximilian University of Würzburg, Germany
Belgium: Federal Agency for Medicinal Products and Health Products
CR-AIR-004
NCT00967343
August 2009
February 2012
Name | Location |
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Ohio State University, Comprehesive Cancer Center | Columbus, Ohio 43210 |