Ignite Creation Date:
2024-05-05 @ 9:46 PM
Last Modification Date:
2024-10-26 @ 10:09 AM
Study NCT ID:
NCT00967343
Status:
TERMINATED
Last Update Posted:
2021-06-14
First Post:
2009-08-26
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
Sponsor:
Kiadis Pharma
Organization:
Kiadis Pharma
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2021-05
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 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
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 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EudraCT no 2008-008198-73 | None | None | None |