Status:
COMPLETED
Cellular Adoptive Immunotherapy in Treating Patients With Relapsed or Refractory Follicular Non-Hodgkin's Lymphoma
Lead Sponsor:
City of Hope Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lymphoma
Eligibility:
All Genders
16-70 years
Phase:
PHASE1
Brief Summary
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. Rit...
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 immuno...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2008
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00182650
Start Date
June 1 2004
End Date
March 1 2008
Last Update
December 29 2009
Active Locations (1)
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1
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000