Ignite Creation Date:
2025-12-26 @ 10:43 PM
Ignite Modification Date:
2026-03-05 @ 11:30 PM
Study NCT ID:
NCT02895412
Status:
UNKNOWN
Last Update Posted:
2016-09-09
First Post:
2016-02-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Infection and Tumour Antigen Cellular Therapy
Sponsor:
University of Sydney
Organization:
Study Overview
Official Title:
A Clinical Trial of Donor-derived WT1 Specific T Cells for Prevention of Relapse in Combination With Multiple Pathogen Specific T Cells for Prevention of Infection in Patients Undergoing Allogeneic Haemopoietic Stem Cell Transplant for AML
Status:
UNKNOWN
Status Verified Date:
2016-09
Last Known Status:
RECRUITING
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:
INTACT-WT1
Brief Summary:
This study is to test a new therapy for patients with acute myeloid leukaemia who are undergoing blood stem cell transplant. In this study, the investigators will take a small number of your immune cells whose normal function is to give immunity to infections and help to fight leukaemia. These cells will be stimulated to multiply in the laboratory and will then be given to the transplant recipient after the transplant. This is a sort of "immunity transplant". The exact purpose of this study is to investigate if these cells are safe and effective in patients having a transplant for AML.
Detailed Description:
The study will analyse the safety and biological efficacy of administering the investigational products (donor-derived Wilm's Tumour Antigen-specific cytotoxic T lymphocytes and with cytotoxic T lymphocytes specific for multiple opportunistic pathogens (cytomegalovirus (CMV), Adenovirus (Adv), Epstein Barr virus (EBV), Varicella-Zoster virus (VZV), Influenza, BK virus (BKV), and fungal infections), hereafter referred to as P-CTLs) for the prophylaxis of relapse, viral and fungal reactivation and infection following allogeneic blood or marrow transplantation for acute myeloid leukaemia. P-CTL will be given prophylactically a minimum of 28 days after transplantation followed by administration of monthly infusions of WT1-CTL for up to four doses. Our aims are to study the safety of combining WT1-CTL and P-CTL infusions; their persistence, effect on relapse of disease, effect on minimal residual disease, reconstitution of WT-1 and pathogen-specific immunity, viral reactivation, infection rates after transplantation, viral load; use of antiviral and antifungal pharmacotherapy for specific infections, hospitalisations and overall survival. Safety of infusions with respect to the development of adverse events within the first 12 months post-transplant will be assessed.
Study Oversight
Has Oversight DMC:
True
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?: