Lymphoma Clinical Trial
Official title:
Pilot/Feasibility 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
RATIONALE: Cellular adoptive immunotherapy uses a person's 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-Hodgkin's lymphoma.
Status | Completed |
Enrollment | 5 |
Est. completion date | March 2008 |
Est. primary completion date | March 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 16 Years to 70 Years |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically confirmed follicular non-Hodgkin's lymphoma (NHL) - High-risk disease, as defined by any of the following: - Relapsed within 6 months after the last treatment - Failed to achieve a complete response during the last treatment - Relapsed after prior autologous hematopoietic stem cell transplantation (HSCT) - No current transformation of lymphoma (e.g., elements of intermediate- or high-grade lymphoma by biopsy) - No active CNS disease by lumbar puncture or radiology scan NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age - 16 to 70 Performance status - Karnofsky 50-100% Life expectancy - More than 16 weeks Hematopoietic - Absolute neutrophil count > 500/mm^3 Hepatic - Bilirubin = 1.5 times upper limit of normal (ULN)* (unless due to Gilbert's disease) - ALT = 2.5 times ULN* NOTE: *Unless due to NHL Renal - Creatinine = 1.5 times ULN* OR - Creatinine clearance = 80 mL/min* NOTE: *Unless due to NHL Immunologic - HIV negative - Epstein-Barr virus positive - No history of allergy or intolerance to ganciclovir Other - Negative pregnancy test - No history of another malignancy except basal cell skin cancer or carcinoma in situ - No other uncontrolled or severe illness that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy - No prior allogeneic HSCT - No other immunotherapy during and for approximately 65 days after the last T-cell infusion, unless approved by the Principal Investigator (PI) Chemotherapy - No other chemotherapy during and for approximately 65 days after the last T-cell infusion, unless approved by the PI - Patients may receive chemotherapy after leukapheresis while waiting for CD19-specific T cells to be manufactured Endocrine therapy - No systemic corticosteroids during and for approximately 65 days after the last T-cell infusion, unless approved by the PI Radiotherapy - Not specified Surgery - Not specified Other - No concurrent participation in another investigational study - No immunosuppression agents or other investigational agents during and for approximately 65 days after the last T-cell infusion, unless approved by the PI |
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | City of Hope Comprehensive Cancer Center | Duarte | California |
Lead Sponsor | Collaborator |
---|---|
City of Hope Medical Center | National Cancer Institute (NCI) |
United States,
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