NCT00996359终止1 期
Partially HLA-Matched Irradiated Allogeneic Cellular Therapy After Reduced Intensity Total Body Irradiation
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Toxicity
研究概览
简要总结
RATIONALE: Giving low-dose total-body irradiation before a donor stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect).
PURPOSE: This phase I trial is studying the side effects of donor stem cell transplant after total-body irradiation and to see how well it works in treating patients with relapsed or refractory hematologic cancer or acute myeloid leukemia or acute lymphocytic leukemia in complete remission.
详细描述
OBJECTIVES:
Primary
- To evaluate the toxicity of irradiated haploidentical allogeneic cellular therapy after low-dose total-body irradiation and no pharmacologic graft-vs-host disease prophylaxis in patients with relapsed or refractory hematologic malignancies or patients with acute myeloid leukemia (AML) or acute lymphoblastic leukemia in second or greater complete remission (CR2).
Secondary
- To evaluate immunologic parameters before and after haploidentical therapy.
- To demonstrate host anti-leukemia T-cells in a subset of patients with AML who are HLA-A2-positive.
- To observe any evidence of antitumor activity within the confines of this pilot study and/or assess the duration of remission in those patients who enter the study in CR2.
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
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Toxicity
时间窗: 3 years
次要结局
- Immunologic parameters before and after haploidentical therapy(3 years)
- Anti-tumor activity and/or duration of remission in those patients who enter the study in second complete remission or greater(3 years)
- Treatment-related mortality(3 years)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Combination Chemotherapy and Donor Stem Cell Transplant in Treating Patients With Aplastic Anemia or Hematologic CancerChronic Myeloproliferative DisordersMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative DiseasesNonmalignant NeoplasmUnspecified Adult Solid Tumor, Protocol SpecificUnspecified Childhood Solid Tumor, Protocol SpecificLymphomaLeukemiaNCT00003816Roswell Park Cancer Institute361
终止
2 期
Donor Stem Cell Transplant in Treating Patients With High-Risk Hematologic CancerMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative DiseasesLymphomaLeukemiaNCT00818961Northside Hospital, Inc.36
已完成
2 期
Fludarabine, Busulfan, Antithymocyte Globulin, and Donor Stem Cell Transplant in Treating Patients With Multiple Myeloma That Has Not Responded to TreatmentMultiple Myeloma and Plasma Cell NeoplasmNCT00802568Institut Paoli-Calmettes48
已完成
2 期
Donor Stem Cell Transplant in Treating Patients With High-Risk Chronic Lymphocytic Leukemia or Small Lymphocytic LymphomaLymphomaLeukemiaNCT01027000Alliance for Clinical Trials in Oncology68
撤回
1 期
Donor Stem Cell Transplant, Pentostatin, and Total-Body Irradiation in Treating Patients With Hematological CancerChronic Myeloproliferative DisordersLeukemiaMyelodysplastic SyndromesNonmalignant NeoplasmLymphomaNCT00816413University of Nebraska