NCT00012207已完成1 期
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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 3
- 主要终点
- Safety and toxicity by NCI CTC toxicity scale in patients w/ recurr. or refract. CD20+ follicular lymphoma who are not candidates for high dose chemoradiotx and stem cell transplant during each infusion, weekly for 4 wks and then monthly for a yr
研究概览
简要总结
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-Hodgkin's lymphoma.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Immunohistopathologically documented relapsed or refractory CD20+ indolent lymphomas or mantle cell lymphoma
- •Indolent B-cell lymphomas including any of the following subtypes:
- •Follicular lymphoma (grade I, II, or III)
- •Small lymphocytic lymphoma or chronic lymphocytic leukemia
- •Marginal zone lymphoma (splenic, nodal, and extra-nodal)
- •Lymphoplasmacytoid lymphoma
- •Ineligible for or unwilling to participate in other FHCRC/UWMC protocols
- •Serological evidence of prior exposure to Epstein-Barr virus
- •Must agree to undergo peripheral blood drawing, bone marrow biopsy, lymph node biopsy, and nuclear medicine imaging
- •Must agree to cytoreductive chemotherapy if necessary to reduce lymph nodes to < 5 cm in diameter or circulating B lymphocyte counts to < 5,000/mm^3
- •No pulmonary involvement
- •No CNS involvement
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Not specified
- •Life expectancy:
- •At least 90 days
- •Hematopoietic:
- •Not specified
- •No active hepatitis B infection
- •Not specified
- •No HIV positivity
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No history of hypersensitivity reactions to murine proteins
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 4 months since prior rituximab, tositumomab, or ibritumomab
- •No prior allogeneic stem cell transplantation
- •No other concurrent immunotherapy (e.g., interferons, vaccines, or other cellular products)
- •Chemotherapy:
- •At least 2 years since prior fludarabine or cladribine
- •At least 4 weeks since prior chemotherapy and recovered
- •Endocrine therapy:
- •No concurrent systemic corticosteroids except to treat toxicity from chemotherapy or cellular immunotherapy
- •Radiotherapy:
- •Not specified
- •Not specified
- •At least 4 weeks since prior immunosuppressive therapy and recovered
- •No concurrent pentoxifylline
- •No other concurrent investigational agents
排除标准
- 未提供
结局指标
主要结局
Safety and toxicity by NCI CTC toxicity scale in patients w/ recurr. or refract. CD20+ follicular lymphoma who are not candidates for high dose chemoradiotx and stem cell transplant during each infusion, weekly for 4 wks and then monthly for a yr
次要结局
- Duration of in vivo persistence of adoptively transferred CD20-specific CD8+ T cell clones by flow cytometry and quantitative polymerase chain reaction (qPCR) during each infusion, weekly for 4 weeks, and then monthly for a year
- Trafficking of CD8+ CD20-specific T cell clones to lymph nodes by Gamma camera imaging during each infusion, weekly for 4 weeks, and then monthly for a year
- Development of host anti-scFvFc:zeta (and anti-NeoR) immune responses by ELISA and chromium release assays during each infusion, weekly for 4 weeks, and then monthly for a year
- Tumor responses to cyclophosphamide, vincristine, and prednisone (CVP) and to cytotoxic T-lymphocyte (CTL) infusions by Cheson criteria during each infusion, weekly for 4 weeks, and then monthly for a year
研究者
研究点 (3)
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