NCT00248430已完成1 期
A Phase I-II Trial of Adoptive Immunotherapy Using Haploidentical, Related Donor-Lymphocyte Infusions and IL-2 After Autologous Stem Cell Transplantation for Advanced Lymphoid Malignancies
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Feasibility
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. An autologous stem cell transplant using the patient's stem cells may be able to replace blood-forming cells that were destroyed by chemotherapy. Giving white blood cells from a donor may help the patient's body destroy any remaining cancer cells. Interleukin-2 may stimulate the white blood cells to kill cancer cells.
PURPOSE: This phase I/II trial is studying the side effects of donor white blood cell infusions and interleukin-2 and to see how well they work in treating patients who are undergoing an autologous stem cell transplant for relapsed advanced lymphoid cancer.
详细描述
OBJECTIVES:
Primary
- Determine the feasibility and toxicity of haploidentical related donor lymphocyte infusions (DLI) and interleukin-2, in terms of acute graft-versus-host-disease, graft failure, and transplant-related mortality, in patients with relapsed advanced lymphoid malignancies undergoing autologous stem cell transplantation.
Secondary
- Determine the extent, degree, and duration of donor chimerism in patients treated with this regimen.
- Determine, preliminarily, activity of haploidentical DLI, as measured by complete response rate, in these patients.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of 1 of the following advanced lymphoid malignancies:
- •Multiple myeloma, meeting both of the following criteria:
- •Deletion of chromosome 13
- •Elevated pre-transplant lactic dehydrogenase
- •Chronic lymphocytic leukemia (CLL)
- •Failed ≥ 2 prior conventional chemotherapy regimens, including fludarabine
- •Small lymphocytic lymphoma
- •Follicular non-Hodgkin's lymphoma
- •Received ≥ 3 prior conventional chemotherapy regimens
- •Mantle cell lymphoma
- •Received ≥ 3 prior conventional chemotherapy regimens
- •Predicted poor outcome and relapsed disease after undergoing autologous stem cell transplantation ≥ 6 months ago
- •Measurable disease, defined as any evidence of disease by scans or blood or urine analysis
- •At least 8 x 10^6 autologous CD34-positive cells/kg available for transplantation
- •Stem cell mobilization allowed
- •Haploidentical related donor available
- •Sex-mismatched
- •Identical for 1 HLA haplotype AND mismatched for ≥ 1 HLA-A, -B, -C, or DRB1 locus of the unshared haplotype
- •No HLA-identical related or unrelated donor available
- •Not eligible for first-line autologous stem cell transplantation on protocol FHCRC-1368.00, FHCRC-1366.00, FHCRC-1461.00, or FHCRC-1595.00
- •No bulky disease, defined as total volume of all measurable tumor > 500 cc
- •No CNS disease resistant to therapy
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Karnofsky 70-100%
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •Liver function tests or liver enzymes ≤ 2 times upper limit of normal
- •Not specified
- •Cardiovascular
- •Ejection fraction ≥ 45%
- •No symptomatic cardiac disease
- •DLCO ≥ 50%
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •HIV Negative
- •No active infection
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •See Disease Characteristics
- •No prior allogeneic stem cell transplantation
- •Chemotherapy
- •See Disease Characteristics
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •Not specified
- 另有 2 项未显示
排除标准
- 未提供
结局指标
主要结局
Feasibility
Toxicity
次要结局
- Extent, degree, and duration of donor chimerism
- Complete response rate
研究者
研究点 (2)
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