Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006100
Status:
UNKNOWN
Last Update Posted:
2013-12-18
First Post:
2000-08-03
Brief Title:
Allogeneic Epstein Barr Virus-Specific Cytotoxic T-Lymphocytes in Treating Patients With Progressive Relapsed or Refractory Hodgkins Lymphoma
Sponsor:
Milton S Hershey Medical Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Pilot Trial to Evaluate the Toxicity of Epstein-Barr Virus Specific T-Lymphocytes or Peripheral Blood Mononuclear Cells for the Treatment of RelapsedRefractory Hodgkins Disease
Status:
UNKNOWN
Status Verified Date:
2005-05
Last Known Status:
ACTIVE_NOT_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:
None
Brief Summary:
RATIONALE Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing Donor white blood cells that are treated in the laboratory with Epstein-Barr virus may be effective treatment for Hodgkins lymphoma
PURPOSE Phase I trial to study the effectiveness of allogeneic Epstein-Barr virus-specific cytotoxic T cells in treating patients who have progressive relapsed or refractory Hodgkins lymphoma
PURPOSE Phase I trial to study the effectiveness of allogeneic Epstein-Barr virus-specific cytotoxic T cells in treating patients who have progressive relapsed or refractory Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Determine the toxicity of allogeneic Epstein Barr virus EBV-specific cytotoxic T-lymphocytes EBV CTL in patients with progressive relapsed or refractory EBV-positive Hodgkins lymphoma
Detect alterations in the anti-EBV cellular immunity of patients treated with EBV CTL
OUTLINE Donors undergo leukapheresis Epstein Barr virus-specific cytotoxic T lymphocytes EBV CTL are cultured in vitro
Patients receive an infusion of EBV CTL over 10 minutes on day 0 The EBV CTL infusion is preceded by 3 doses of fludarabine Patients then receive interleukin-2 injections for 12 days after the EBV CTL infusion
Patients are followed weekly for 15 months twice a month for 15 months and then monthly for 3 months
PROJECTED ACCRUAL A total of 9 patients will be accrued for this study
Determine the toxicity of allogeneic Epstein Barr virus EBV-specific cytotoxic T-lymphocytes EBV CTL in patients with progressive relapsed or refractory EBV-positive Hodgkins lymphoma
Detect alterations in the anti-EBV cellular immunity of patients treated with EBV CTL
OUTLINE Donors undergo leukapheresis Epstein Barr virus-specific cytotoxic T lymphocytes EBV CTL are cultured in vitro
Patients receive an infusion of EBV CTL over 10 minutes on day 0 The EBV CTL infusion is preceded by 3 doses of fludarabine Patients then receive interleukin-2 injections for 12 days after the EBV CTL infusion
Patients are followed weekly for 15 months twice a month for 15 months and then monthly for 3 months
PROJECTED ACCRUAL A total of 9 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G00-1829 | None | None | None |
| PSCI-2003-257 | None | None | None |
| UAB-0002 | None | None | None |