NCT00176475终止1 期
A Pilot Study of Irradiated HLA-Partially Matched Allogeneic Related Donor Lymphocytes in Conjunction With Rituximab for Selected Patients With CD20 + Malignancies
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Toxicity as assessed by NCI CTCAE v3.0
研究概览
简要总结
RATIONALE: When irradiated lymphocytes from a donor are infused into the patient they may help the patient's immune system kill cancer cells. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving irradiated donor lymphocytes together with rituximab may kill more cancer cells.
PURPOSE: This clinical trial is studying the side effects and how well giving irradiated donor lymphocytes together with rituximab works in treating patients with relapsed or refractory lymphoproliferative disease.
详细描述
OBJECTIVES:
Primary
- Determine the toxicity of irradiated HLA-partially matched related donor lymphocytes when administered with rituximab in patients with relapsed or refractory CD20-positive lymphoproliferative disease.
- Determine the efficacy of this regimen in these patients.
Secondary
- Correlate response with Fc receptor FcγIIIA polymorphisms or predicted HLA-directed natural killer cell reactivity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed lymphoproliferative disease
- •CD20-positive disease
- •Bidimensionally measurable disease OR abnormal cells detected in blood
- •Resistant or refractory to standard therapies and/or unlikely to benefit from additional standard therapies* AND meets 1 of the following criteria:
- •Disease with anticipated response rate < 20% after treatment with rituximab alone, including any of the following:
- •Diffuse large cell lymphoma
- •B-cell lymphoblastic lymphoma
- •Burkitt's lymphoma
- •Acute lymphocytic leukemia
- •Relapsed or progressive disease after prior treatment with rituximab, including any of the following:
- •Hodgkin's lymphoma
- •Hairy cell leukemia
- •Chronic lymphocytic leukemia/small lymphocytic lymphoma meeting any of the following criteria:
- •Received prior fludarabine phosphate-containing regimens and relapsed within 1 year of treatment OR ineligible to receive such therapy due to comorbidities or allergies
- •Received prior anti-CD52 monoclonal antibody therapy and relapsed within 1 year of treatment OR ineligible to receive such therapy (for patients without symptomatic lymphadenopathy)
- •Has documentation of disease-associated symptoms, rapid disease progression, or other indications for treatment
- •B-cell prolymphocytic leukemia meeting any of the following criteria:
- •Received prior fludarabine phosphate- or alkylating agent-containing regimens and relapsed within 1 year of treatment OR ineligible to receive such therapy due to comorbidities or allergies
- •Received prior anti-CD52 monoclonal antibody therapy OR ineligible to receive such therapy (for patients without symptomatic lymphadenopathy)
- •Lymphoplasmacytic lymphoma, marginal zone lymphoma, mucosa-associated lymphoid tissue lymphoma, or follicular lymphoma meeting any of the following criteria:
- •Received prior fludarabine phosphate- and/or alkylating agent-containing regimens and relapsed within 1 year of treatment OR ineligible to receive such therapy due to comorbidities or allergies
- •Received prior anti-CD20 monoclonal antibody therapy and relapsed within 1 year of treatment OR ineligible to receive such therapy
- •Received prior radioconjugated anti-CD20 monoclonal antibody therapy OR ineligible to receive such therapy
- •Has documentation of disease-associated symptoms, rapid disease progression, or other indications for treatment
- •Multiple myeloma meeting any of the following criteria:
- •Received prior alkylating agent-, thalidomide-, corticosteroid-, or bortezomib-containing regimens and relapsed after 1 year of treatment OR ineligible to receive such therapies due to comorbidities or allergies
- •Received prior high-dose chemotherapy followed by autologous hematopoietic stem cell rescue and relapsed after treatment OR ineligible to receive such therapy
- •Mantle cell lymphoma meeting the following criteria:
- •Received prior combination chemotherapy and anti-CD20 monoclonal antibody therapy and relapsed after treatment OR ineligible to receive such therapy
- •Diffuse large B-cell lymphoma meeting any of the following criteria:
- •Received prior combination chemotherapy and relapsed after treatment OR ineligible to receive such therapy
- •Received prior salvage combination chemotherapy with or without high-dose chemotherapy followed by autologous hematopoietic stem cell rescue and relapsed after treatment OR not a candidate to receive such therapy
- •Received prior radiolabeled anti-CD20 monoclonal antibody therapy for transformed large cell lymphoma OR ineligible to receive such therapy
- •Burkitt's lymphoma meeting any of the following criteria:
- •Received prior combination chemotherapy and relapsed after treatment OR ineligible to receive such therapy
- •Received prior salvage combination chemotherapy with or without high-dose chemotherapy followed by autologous hematopoietic stem cell rescue and relapsed after treatment OR ineligible to receive such therapy
- •Lymphomatoid granulomatosis meeting any of the following criteria:
- •Received prior single-agent or combination chemotherapy and relapsed after treatment OR ineligible to receive such therapy
- •Has documentation of disease-associated symptoms, rapid disease progression, or other indications for treatment
- •Acute lymphocytic leukemia meeting any of the following criteria:
- •Received prior multi-agent combination chemotherapy administered in sequential induction, consolidation, and maintenance courses and relapsed during or after treatment OR ineligible to receive such therapy
- •Received prior chemotherapy with or without radiotherapy followed by allogeneic hematopoietic stem cell transplantation (HSCT) and relapsed after treatment OR not a candidate for such therapy
- •Received prior treatment with chemotherapy with or without radiotherapy followed by allogeneic HSCT and relapsed after treatment (or not a candidate for such therapy) AND demonstrates persistent cytogenetic, fluorescent in situ hybridization, or molecular (reverse transcriptase-polymerase chain reaction) evidence of the bcr-abl fusion gene despite 6 weeks of treatment with imatinib mesylate NOTE: *Not eligible to receive standard available salvage regimens anticipated to result in durable remission
- •No active CNS malignancy
- •Not considered a candidate for allogeneic HSCT
- •HLA-partially matched (≥ 2/6) related donor available
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-1
- •Life expectancy > 3 months
- 另有 18 项未显示
排除标准
- 未提供
研究组 & 干预措施
Therapeutic allogeneic lymphocytes with rituximab
Experimental
干预措施: therapeutic allogeneic lymphocytes (Biological)
Therapeutic allogeneic lymphocytes with rituximab
Experimental
干预措施: rituximab (Biological)
结局指标
主要结局
Toxicity as assessed by NCI CTCAE v3.0
时间窗: 4 years
次要结局
- Efficacy(4 years)
研究者
研究点 (1)
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