Ignite Creation Date:
2024-05-05 @ 9:56 PM
Last Modification Date:
2024-10-26 @ 10:11 AM
Study NCT ID:
NCT00993486
Status:
COMPLETED
Last Update Posted:
2013-06-20
First Post:
2009-10-09
Brief Title:
Dose-ranging Study of a Single Administration of T-cell Add-back Depleted of Host Alloreactive Cells in Patients Undergoing a Peripheral Blood Stem Cell Transplant From a Related Haploidentical Donor
Sponsor:
Kiadis Pharma
Organization:
Kiadis Pharma
Study Overview
Official Title:
Phase I Dose-ranging Open-label Study of a Single Administration of T-cells Add-back Depleted of Host Alloreactive Cells Using Theralux Therapy Following Haploidentical Peripheral Blood Stem Cell Transplantation Submitted to CD34 Cell Selection in Patients With Severe Hematologic Malignancies
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the maximum tolerated dose and evaluate the safety of the administration of donor lymphocytes depleted of alloreactive T-cells following a stem cell transplant from a related haploidentical donor in patients with severe hematologic malignancies
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 of 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 alloreactive T-cells ATIR are administered to the patient 4-6 weeks after the stem cell transplant This method enables early immune reconstitution while preventing graft-versus-host disease
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 alloreactive T-cells ATIR are administered to the patient 4-6 weeks after the stem cell transplant This method enables early immune reconstitution while preventing graft-versus-host disease
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None