Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00012207
Status:
COMPLETED
Last Update Posted:
2010-08-24
First Post:
2001-03-03
Brief Title:
Biological Therapy After Chemotherapy in Treating Patients With Relapsed or Refractory Non-Hodgkins Lymphoma
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
A Phase I Study To Evaluate The Safety Of Cellular Immunotherapy Using Genetically Modified Autologous Cd20-Specific Cd8 T Cell Clones For Patients With Relapsed Cd20 Indolent Lymphomas
Status:
COMPLETED
Status Verified Date:
2010-08
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:
RATIONALE Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Combining biological therapy with chemotherapy may kill more cancer cells
PURPOSE Phase I trial to study the effectiveness of biological therapy after chemotherapy in treating patients who have relapsed or refractory non-Hodgkins lymphoma
PURPOSE Phase I trial to study the effectiveness of biological therapy after chemotherapy in treating patients who have relapsed or refractory non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Primary
Determine the safety and toxicity of cellular immunotherapy with autologous CD8 cytotoxic T-lymphocyte clones after chemotherapy comprising cyclophosphamide vincristine and prednisone in patients with relapsed or refractory CD20 indolent lymphomas or mantle cell lymphoma
Secondary
Determine the duration of in vivo persistence of adoptively transferred CD20-specific CD8 cytotoxic T-lymphocyte clones in the absence and presence of subcutaneous interleukin-2 in these patients
Assess the trafficking of CD8 cytotoxic T-lymphocyte clones to lymph nodes in these patients treated with this regimen
Determine immune response and tumor response in patients treated with this regimen
OUTLINE This is an open-label pilot study
Leukapheresis Patients undergo leukapheresis Selected CD20-specific CD8 cells are cultured to expand the cytotoxic T lymphocytes CTL which are then cloned
Chemotherapy
Patients receive oral cyclophosphamide and oral prednisone on days 1-5 and vincristine IV on day 1 Courses repeat every 3-4 weeks for a total of 6 courses
Immune cell infusion
Beginning 4 weeks after the last course of chemotherapy and lymph nodes 5 cm diameter or 5000 circulating CD20 lymphocytesmm3 patients receive autologous CD8 CTL clones IV over 30 minutes Courses repeat every 2-5 days for a total of 3 courses in the absence of disease progression or unacceptable toxicity The last 6 patients receive interleukin-2 subcutaneously every 12 hours for 14 days beginning 2 hours after the last infusion of CD8 CTL clones
After course 2 or 3 of immune cells all patients undergo surgical lymph node biopsy to determine if immune cells are moving to the lymph nodes
Patients are followed monthly for 1 year and then annually for 2 years
PROJECTED ACCRUAL A total of 12 patients will be accrued for this study within 4 years
Primary
Determine the safety and toxicity of cellular immunotherapy with autologous CD8 cytotoxic T-lymphocyte clones after chemotherapy comprising cyclophosphamide vincristine and prednisone in patients with relapsed or refractory CD20 indolent lymphomas or mantle cell lymphoma
Secondary
Determine the duration of in vivo persistence of adoptively transferred CD20-specific CD8 cytotoxic T-lymphocyte clones in the absence and presence of subcutaneous interleukin-2 in these patients
Assess the trafficking of CD8 cytotoxic T-lymphocyte clones to lymph nodes in these patients treated with this regimen
Determine immune response and tumor response in patients treated with this regimen
OUTLINE This is an open-label pilot study
Leukapheresis Patients undergo leukapheresis Selected CD20-specific CD8 cells are cultured to expand the cytotoxic T lymphocytes CTL which are then cloned
Chemotherapy
Patients receive oral cyclophosphamide and oral prednisone on days 1-5 and vincristine IV on day 1 Courses repeat every 3-4 weeks for a total of 6 courses
Immune cell infusion
Beginning 4 weeks after the last course of chemotherapy and lymph nodes 5 cm diameter or 5000 circulating CD20 lymphocytesmm3 patients receive autologous CD8 CTL clones IV over 30 minutes Courses repeat every 2-5 days for a total of 3 courses in the absence of disease progression or unacceptable toxicity The last 6 patients receive interleukin-2 subcutaneously every 12 hours for 14 days beginning 2 hours after the last infusion of CD8 CTL clones
After course 2 or 3 of immune cells all patients undergo surgical lymph node biopsy to determine if immune cells are moving to the lymph nodes
Patients are followed monthly for 1 year and then annually for 2 years
PROJECTED ACCRUAL A total of 12 patients will be accrued for this study within 4 years
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 |
|---|---|---|---|
| FHCRC-150300 | None | None | None |
| NCI-G01-1921 | None | None | None |
| CDR0000068494 | REGISTRY | PDQ | None |