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Brief Title: Efficacy and Safety of a Donor Lymphocyte Preparation Depleted of Functional Host Alloreactive T-cells (ATIR) in Patients Undergoing a Peripheral Blood Stem Cell Transplant From a Related, Haploidentical Donor
Official Title: 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
Study ID: NCT00967343
Brief Summary: 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 .
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Ohio State University, Comprehesive Cancer Center, Columbus, Ohio, United States
Algemeen Ziekenhuis Sint-Jan, Brugge, , Belgium
Université Libre de Bruxelles - Institute Jules Bordet, Brussels, , Belgium
Universitair Ziekenhuis Gasthuisberg, Leuven, , Belgium
University of Liege - CHU Sart Tilman, Liege, , 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, , Germany
Universitätsklinikums Schleswig-Holstein Campus Kiel, Kiel, , Germany
Universitätsklinikum Mainz, Mainz, , Germany
Universitätsklinikum Würzburg, Würzburg, , Germany
Perugia University, Perugia, , Italy
Academisch Ziekenhuis Maastricht, Maastricht, , Netherlands
Hammersmith Hospital, London, , United Kingdom
Name: Stephan Mielke, MD
Affiliation: Julius Maximilian University of Würzburg, Germany
Role: STUDY_CHAIR
Name: Denis-Claude Roy, MD
Affiliation: Maisonneuve-Rosemont Hospital, Montreal, Canada
Role: STUDY_CHAIR
Name: Andrea Velardi, MD
Affiliation: University Of Perugia
Role: PRINCIPAL_INVESTIGATOR
Name: Katy Rezvani, MD PhD
Affiliation: Hammersmith Hospital, London, United Kingdom
Role: PRINCIPAL_INVESTIGATOR