Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00182650
Status:
COMPLETED
Last Update Posted:
2009-12-29
First Post:
2005-09-15
Brief Title:
Cellular Adoptive Immunotherapy in Treating Patients With Relapsed or Refractory Follicular Non-Hodgkins Lymphoma
Sponsor:
City of Hope Medical Center
Organization:
City of Hope Medical Center
Study Overview
Official Title:
PilotFeasibility Study To Evaluate The Safety Of Cellular Immunotherapy For CD19 Follicular Lymphoma Using Autologous Cytolytic T Cells Genetically-Modified To Be CD19-Specific And Co-Express HyTK
Status:
COMPLETED
Status Verified Date:
2009-12
Last Known Status:
None
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 Cellular adoptive immunotherapy uses a persons white blood cells that are treated in the laboratory to stimulate the immune system in different ways and stop cancer cells from growing Rituximab and fludarabine may also prevent the body from making an immune response against the laboratory-treated white blood cells that are put back into the body Interleukin-2 may help the laboratory-treated white blood cells stay in the body longer Giving cellular adoptive immunotherapy together with rituximab fludarabine and interleukin-2 may kill more cancer cells
PURPOSE This phase I trial is studying the side effects of cellular adoptive immunotherapy in treating patients with relapsed or refractory follicular non-Hodgkins lymphoma
PURPOSE This phase I trial is studying the side effects of cellular adoptive immunotherapy in treating patients with relapsed or refractory follicular non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Primary
Determine the safety and feasibility of cellular adoptive immunotherapy using autologous cytotoxic T lymphocytes genetically modified to express a CD19-specific chimeric immunoreceptor gene and HyTK selectionsuicide gene in patients with relapsed or refractory follicular non-Hodgkins lymphoma
Secondary
Determine the in vivo persistence of adoptively transferred cytolytic T cells in patients treated with lymphodepleting therapy comprising rituximab and fludarabine
Assess the development of host immune responses against the CD19-specific chimeric immunoreceptor gene andor HyTK selectionsuicide gene
Determine the safety of low-dose interleukin-2 in supporting in vivo persistence of adoptively transferred cytotoxic T cells
Determine the anti-tumor activity of this regimen in these patients
OUTLINE This is a nonrandomized open-label pilot study
Leukapheresis Patients undergo leukapheresis for collection of peripheral blood mononuclear cells PBMCs CD3-positive cytotoxic T lymphocytes CTLs are isolated and genetically modified to express a CD19-specific chimeric immunoreceptor and the HyTK fusion protein and are then expanded in vitro
Lymphodepleting therapy Patients receive rituximab and fludarabine prior to T-cell infusions
Cellular adoptive immunotherapy and interleukin-2 IL-2 Patients receive a total of 5 infusions of genetically modified autologous T cells Patients may receive low-dose IL-2 subcutaneously after infusions 3 4 and 5
Additional IL-2 therapy After the completion of the last T-cell infusion patients with evidence of adoptively transferred T cells may receive additional IL-2
After completion of study treatment patients are followed periodically for approximately 65 days and then annually for at least 15 years
PROJECTED ACCRUAL At least 5 patients will be accrued for this study within 3 years
Primary
Determine the safety and feasibility of cellular adoptive immunotherapy using autologous cytotoxic T lymphocytes genetically modified to express a CD19-specific chimeric immunoreceptor gene and HyTK selectionsuicide gene in patients with relapsed or refractory follicular non-Hodgkins lymphoma
Secondary
Determine the in vivo persistence of adoptively transferred cytolytic T cells in patients treated with lymphodepleting therapy comprising rituximab and fludarabine
Assess the development of host immune responses against the CD19-specific chimeric immunoreceptor gene andor HyTK selectionsuicide gene
Determine the safety of low-dose interleukin-2 in supporting in vivo persistence of adoptively transferred cytotoxic T cells
Determine the anti-tumor activity of this regimen in these patients
OUTLINE This is a nonrandomized open-label pilot study
Leukapheresis Patients undergo leukapheresis for collection of peripheral blood mononuclear cells PBMCs CD3-positive cytotoxic T lymphocytes CTLs are isolated and genetically modified to express a CD19-specific chimeric immunoreceptor and the HyTK fusion protein and are then expanded in vitro
Lymphodepleting therapy Patients receive rituximab and fludarabine prior to T-cell infusions
Cellular adoptive immunotherapy and interleukin-2 IL-2 Patients receive a total of 5 infusions of genetically modified autologous T cells Patients may receive low-dose IL-2 subcutaneously after infusions 3 4 and 5
Additional IL-2 therapy After the completion of the last T-cell infusion patients with evidence of adoptively transferred T cells may receive additional IL-2
After completion of study treatment patients are followed periodically for approximately 65 days and then annually for at least 15 years
PROJECTED ACCRUAL At least 5 patients will be accrued for this study within 3 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 |
|---|---|---|---|
| CHNMC-IRB-01160 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA033572 |
| R21CA105824 | NIH | None | None |
| P30CA033572 | NIH | None | None |