NCT00161187已完成1 期
A Pilot Study of Irradiated HLA-Partially Matched Allogeneic Related Donor Lymphocytes for Patients With Selected Malignancies
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Toxicity
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.
PURPOSE: This pilot study is looking at the side effects and how well irradiated donor lymphocyte infusion works in treating patients with relapsed or refractory hematologic cancer or solid tumor.
详细描述
OBJECTIVES:
- Determine the toxicity of irradiated allogeneic donor lymphocyte infusion in patients with relapsed or refractory hematological cancer or solid tumor.
- Determine the response in patients treated with this regimen.
- Determine the presence of disease or antigen-specific lymphocytes in patients treated with this regimen.
OUTLINE: This is a pilot, open-label, controlled study.
Patients undergo irradiated allogeneic donor lymphocyte infusion over 1 hour on day 1. Treatment repeats every 8-16 weeks for up to 6 infusions in the absence of disease progression or unacceptable toxicity.
Blood samples are collected periodically and analyzed for lymphocytotoxicity directed towards patients' cells (normal and malignant cells) and for disease or antigen-specific cells. Samples are also analyzed for survival of donor lymphocytes by chimerism studies.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed diagnosis of 1 of the following:
- •Hematologic cancer, including any of the following:
- •Chronic lymphocytic leukemia or small lymphocytic lymphoma meeting any of the following criteria:
- •Relapsed within 1 year after prior fludarabine phosphate-containing regimens OR not a candidate 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)
- •Has documentation of disease-associated symptoms, rapid progression of disease, or other indications for treatment
- •B- or T-cell prolymphocytic leukemia meeting any of the following criteria:
- •Relapsed within 1 year after prior fludarabine phosphate- or alkylating agent-containing regimens OR not a candidate to receive such therapy due to comorbidities or allergies
- •Relapsed within 1 year after prior anti-CD20 monoclonal antibody therapy OR ineligible to receive such therapy (for patients with CD20-positive disease)
- •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:
- •Relapsed within 1 year after prior fludarabine phosphate- or alkylating agent-containing regimens or radioconjugated anti-CD20 monoclonal antibody OR not a candidate to receive such therapy due to comorbidities or allergies
- •Relapsed within 1 year after prior anti-CD20 monoclonal antibody therapy OR ineligible to receive such therapy (for patients with CD20-positive disease)
- •Has documentation of disease-associated symptoms, rapid progression of disease, or other indications for treatment
- •Multiple myeloma meeting any of the following criteria:
- •Relapsed after prior alkylating agents, thalidomide, corticosteroids, or bortezomib OR not a candidate to receive such therapy due to comorbidities or allergies
- •Relapsed after prior high-dose chemotherapy followed by autologous hematopoietic stem cell rescue OR not a candidate to receive such therapy
- •Mantle cell lymphoma that has relapsed after prior combination chemotherapy or anti-CD20 monoclonal antibody OR not a candidate to receive such therapy
- •Diffuse large B-cell lymphoma meeting any of the following criteria:
- •Relapsed after prior salvage combination chemotherapy with or without high-dose chemotherapy followed by autologous hematopoietic stem cell rescue OR not a candidate to receive such therapy
- •Received prior radiolabeled anti-CD20 monoclonal antibody OR ineligible to receive such therapy (for patients with transformed large cell lymphoma)
- •Burkitt's lymphoma
- •Relapsed after prior salvage combination chemotherapy with or without high-dose chemotherapy followed by autologous hematopoietic stem cell rescue OR not a candidate for such therapy
- •Lymphomatoid granulomatosis or mature T-cell or NK-cell neoplasms meeting any of the following criteria:
- •Relapsed after prior single agent or combination chemotherapy OR not a candidate to receive such therapy
- •Has documentation of disease-associated symptoms, rapid progression of disease, or other indications for treatment
- •Mycosis fungoides or Sezary syndrome
- •Relapsed after prior combination chemotherapy, interferon-α, denileukin diftitox, or extracorporeal photophoresis OR not a candidate to receive such therapy
- •Anaplastic large cell lymphoma, peripheral T-cell lymphoma unspecified, or angioimmunoblastic T-cell lymphoma meeting the following criteria:
- •Relapsed after prior salvage combination chemotherapy with or without high-dose chemotherapy followed by autologous hematopoietic stem cell rescue OR not a candidate to receive such therapy
- •Hepatosplenic T-cell lymphoma or adult T-cell leukemia/lymphoma
- •Relapsed after prior salvage combination chemotherapy OR not a candidate to receive such therapy
- •Hodgkin's lymphoma
- •Relapsed after prior salvage combination chemotherapy with or without high-dose chemotherapy followed by autologous hematopoietic stem cell rescue OR not a candidate to receive such therapy
- •Acute lymphocytic leukemia meeting any of the following criteria:
- •Relapsed during or after prior multi-agent combination chemotherapy administered in sequential induction, consolidation, and maintenance courses OR not a candidate to receive such therapy
- •Relapsed after prior salvage combination chemotherapy with or without high-dose chemotherapy followed by autologous hematopoietic stem cell rescue OR not a candidate to receive such therapy
- •Relapsed after prior chemotherapy with or without radiotherapy followed by allogeneic hematopoietic stem cell transplant (or ineligible for such therapy) AND demonstrates persistent cytogenetic, fluorescent in situ hybridization (FISH), or molecular (reverse transcriptase-polymerase chain reaction) evidence of bcr-abl fusion gene despite 6 weeks of treatment with imatinib mesylate
- •Acute myelogenous leukemia or myelodysplasia meeting any of the following criteria:
- •Relapsed or refractory disease after prior induction chemotherapy (anthracycline and cytarabine, topotecan hydrochloride and cytarabine, or comparable regimen) OR not a candidate to receive such therapy
- •Not a candidate for chemotherapy with or without radiotherapy followed by allogeneic or autologous hematopoietic stem cell transplant
- •Patients with acute promyelomonocytic leukemia must have received prior tretinoin and arsenic trioxide
- •Chronic myelogenous leukemia meeting any of the following criteria:
- •Relapsed or refractory disease after prior imatinib mesylate
- •Not a candidate for chemotherapy with or without radiotherapy followed by allogeneic hematopoietic stem cell transplant
- •Chronic phase disease allowed if there is FISH or cytogenetic evidence of increasing disease
- •Solid tumor, including any of the following:
- •Renal cell carcinoma
- •Metastatic relapsed or refractory disease after prior high-dose aldesleukin OR ineligible to receive such therapy due to comorbidities OR did not consent to treatment
- 另有 40 项未显示
排除标准
- 未提供
研究组 & 干预措施
Treatment
Experimental
Biological/Vaccine: therapeutic allogeneic lymphocytes The total CD3+ cell dose target is 1.8 x 108 CD3+ cells/kg +/- 1.0 x 108 CD3+ cells/kg. Up to 6 cycles.
干预措施: therapeutic allogeneic lymphocytes (Biological)
结局指标
主要结局
Toxicity
时间窗: 10 years
次要结局
- Response(10 years)
- Presence of disease or antigen-specific lymphocytes(10 years)
研究者
研究点 (1)
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