Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00058656
Status:
COMPLETED
Last Update Posted:
2006-11-22
First Post:
2003-04-08
Brief Title:
Autologous T Cell Immunotherapy for Chronic Lymphocytic Leukemia CLL Patients
Sponsor:
Xcyte Therapies
Organization:
Xcyte Therapies
Study Overview
Official Title:
A Phase III Study of Xcellerated T Cellstm in Patients With Chronic Lymphocytic Leukemia CLL
Status:
COMPLETED
Status Verified Date:
2005-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients will have immune cells collected and then expanded outside of the body Patients will receive an infusion of a large number of expanded immune cells There will be three dose levels studied The goal of the study will be to determine the safety as well as potential efficacy of this treatment
Detailed Description:
This is a Phase III single arm dose escalation study of a novel T cell immunotherapy for chronic lymphocytic leukemia CLL Patients will receive one dose of Xcellerated T Cellstm an ex vivo activated and expanded autologous T cell product in an attempt to enhance immune responses with anti-tumor activity This study is being conducted to test the safety and determine the maximum tolerated dose MTD of Xcellerated T Cells in patients with CLL In addition lymphocyte counts lymph node area and quantitative immunoglobulins will be assessed for preliminary evidence of a therapeutic effect In correlative studies changes in the phenotype of T and B lymphocytes will be evaluated by flow cytometry Changes in T cell repertoire and anti-tumor immune activity will also be assessed It is expected that 12 to 18 patients will be treated
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