NCT00823524已完成1 期
Donor NK Cell Infusion for Progression/Recurrence of Underlying Malignant Disorders After HLA-haploidentical HCT - a Phase 1-2 Study
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
RATIONALE: Giving an infusion of natural killer cells from a donor after a donor stem cell transplant may help kill any remaining cancer cells after the transplant.
PURPOSE: This phase I/II trial is studying the side effects and best dose of donor natural killer cells when given after a donor stem cell transplant in treating patients with advanced cancer.
详细描述
OBJECTIVES:
Primary
- To assess the safety of donor natural killer (NK) cell infusion after HLA-mismatched/haploidentical allogeneic hematopoietic stem cell transplantation from a familial donor in patients with advanced malignant disorders.
- To determine the maximum number of donor NK cells that can be safely given to these patients.
Secondary
- To assess the clinical efficacy donor NK cell infusion, in terms of tumor response, response duration, and survival, in patients with progressive or recurrent malignant disorders.
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
- 15 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of a malignant disorder (hematologic malignancies or solid tumors)
- •Advanced disease
- •Has undergone prior allogeneic hematopoietic stem cell transplantation (HSCT) from an HLA-mismatched/haploidentical familial donor
- •Progressive or recurrent disease, as defined by any of the following (phase II):
- •Peripheral blood blast > 20% with bone marrow aspirate showing > 5% leukemic cells (in patients with acute leukemia)
- •Detection of metaphases in the marrow with the same clonal cytogenetic abnormalities as identified before HSCT (or by FISH markers, if appropriate) (in patients with acute leukemia or high-risk myelodysplastic syndromes [MDS])
- •Persistent cytopenia with bone marrow aspirate showing various degrees of dysplasia involving ≥ 1 cell lineage (in patients with high-risk MDS)
- •Enlargement of pre-existing measurable lesions by 20% according to RECIST criteria (in patients with solid tumors or lymphoma)
- •Appearance of new metastatic lesions, including pleural effusion or ascites, radiologically typical for metastases or confirmed as such by cytology (in patients with solid tumors or lymphoma)
- •Measurable disease (phase II)
- •PATIENT CHARACTERISTICS:
- •Karnofsky performance status 70-100%
- •Total bilirubin < 3.0 mg/dL
- •AST < 5 times upper limit of normal
- •Creatinine < 3 mg/dL
- •Not pregnant or nursing
- •No clinically evident cardiac or pulmonary failure
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
排除标准
- 未提供
研究组 & 干预措施
donor NK cell infusion
Experimental
give patients donor-derived NK cells 2 to 3 weeks after HLA-haploidentical hematopoietic cell transplantation
干预措施: donor natural killer cell infusion (Biological)
结局指标
主要结局
Safety
时间窗: 15 days to 1 year after transplantation
Safety will be evaluation in terms of transplantation outcomes as well as side effects of donor NK cell infusion
次要结局
- Clinical efficacy of donor NK cell infusion, in terms of tumor response, response duration, and survival(15 days to 1 year)
研究者
Kyoo-Hyung Lee
Professor of Internal Medicine
Asan Medical Center
研究点 (1)
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