Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00081783
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2004-04-20
Brief Title:
Xcellerated T CellsTM for Non-Hodgkins Lymphoma NHL Patients
Sponsor:
Xcyte Therapies
Organization:
Xcyte Therapies
Study Overview
Official Title:
A Phase II Study of Xcellerated T CellsTM in Patients With Relapsed or Refractory Indolent Non-Hodgkins Lymphoma NHL
Status:
UNKNOWN
Status Verified Date:
2005-03
Last Known Status:
RECRUITING
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:
This is a Phase II single arm study of a novel T cell immunotherapy in patients with indolent non-Hodgkins lymphoma NHL Eligible patients will have relapsed or refractory disease after receiving at least one and no more than four prior regimens Patients will receive Xcellerated T CellsTM an ex vivo activated and expanded autologous T cell product in an attempt to enhance immune responses with anti-tumor activity The primary endpoint of the study is to evaluate the efficacy of Xcellerated T Cells in patients with indolent NHL Secondary endpoints are to evaluate the safety of the therapy in this patient population and to evaluate changes in the number and phenotype of T- and B-lymphocytes as well as changes in the T cell receptor repertoire hemoglobin levels platelet counts and quantitative immunoglobulin levels In a subset of patients fine-needle aspirates of malignant lymph nodes will be performed to assess changes in the lymphocyte composition and phenotype Bone marrow aspirates will be similarly evaluated Finally anti-tumor immune responses will be evaluated in patients amenable to biopsy of enlarged lymph nodes
Detailed Description:
None
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