Ignite Creation Date:
2024-05-06 @ 1:23 AM
Last Modification Date:
2024-10-26 @ 11:03 AM
Study NCT ID:
NCT01794299
Status:
COMPLETED
Last Update Posted:
2021-04-12
First Post:
2013-02-14
Brief Title:
Safety and Efficacy of Donor T-lymphocytes Depleted ex Vivo of Host Alloreactive T-cells ATIR in Patients With a Hematologic Malignancy Who Received a Hematopoietic Stem Cell Transplantation From a Haploidentical Donor
Sponsor:
Kiadis Pharma
Organization:
Kiadis Pharma
Study Overview
Official Title:
An Exploratory Open-label Multicenter Study to Evaluate the Safety and Efficacy of ATIR Donor T-lymphocytes Depleted ex Vivo of Host Alloreactive T-cells in Patients With a Hematologic Malignancy Who Received a CD34-selected Hematopoietic Stem Cell Transplantation From a Haploidentical Donor
Status:
COMPLETED
Status Verified Date:
2021-03
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 ATIR is safe and effective in reducing transplant-related mortality and improving overall survival when infused in patients with a hematologic malignancy following a T-cell depleted stem cell graft from a related haploidentical donor
Detailed Description:
Study CR-AIR-007 is an exploratory open-label multicenter study After signing informed consent patients will receive a hematopoietic stem cell transplantation HSCT from a related haploidentical donor followed by infusion with ATIR between 28 and 32 days after the HSCT or later if required by the patients medical condition Patients will receive ATIR as a single infusion at a dose of 2x10E6 viable T-cellskg All patients treated with ATIR will be followed up until 12 months after the HSCT Assessments will be performed at weekly visits from the day of ATIR infusion until 8 weeks after ATIR infusion at monthly visits from 3 until 6 months after the HSCT every 2 months from 6 until 12 months after the HSCT and every 6 months from 12 until 24 months after the HSCT
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 |
|---|---|---|---|
| File 9427-K09801-21C | OTHER | Health Canada | None |
| 2012-004461-41 | EUDRACT_NUMBER | None | None |