A Phase I Study of Photochemically Treated Donor T-Cell Supplements in HLA Haplotype Mismatched Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 3
- 主要终点
- Maximum Tolerated Dose (MTD) of T-cells photochemically treated with psoralen and ultraviolet A
研究概览
简要总结
RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by the chemotherapy or radiation therapy used to kill tumor cells. Sometimes the transplanted cells are rejected by the body's normal tissues. Transplanting donated cells that have been treated with psoralen may prevent this from happening.
PURPOSE: Phase I trial to study the effectiveness of chemotherapy, radiation therapy, and psoralen-treated donor cells in treating patients who are undergoing peripheral stem cell transplantation for hematologic cancer.
详细描述
OBJECTIVES: I. Determine the maximum tolerated dose of T-cells photochemically treated with psoralen and ultraviolet A given with peripheral stem cell transplantation in patients with hematologic malignancies or bone marrow failure myelodysplastic syndrome. II. Assess the toxicity of this treatment in these patients. III. Evaluate this regimen in terms of prevention of graft versus host disease and control of malignancy in these patients.
OUTLINE: This is a dose escalation, multicenter study of T-cells photochemically treated with psoralen and ultraviolet A. Patients receive thiotepa IV over 2 hours on day 1, cyclophosphamide IV over 2 hours on days 2 and 3, and whole body radiotherapy on days 5-8. Patients undergo preserved stem cell or bone marrow allogeneic transplant plus psoralen treated T-cell allogeneic transplant on day 9. Cohorts of 3-6 patients receive escalating doses of photochemically treated T-cells until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose limiting toxicities. Patients are followed for 100 days.
PROJECTED ACCRUAL: A maximum of 37 patients will be accrued for this study.
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
- — 至 49 Years（Child, 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
研究组 & 干预措施
Chemo, RT + PSCT
Chemotherapy, Radiation Therapy, and Peripheral Stem Cell Transplantation
干预措施: Cyclophosphamide (Drug)
Chemo, RT + PSCT
Chemotherapy, Radiation Therapy, and Peripheral Stem Cell Transplantation
干预措施: Psoralen (Drug)
Chemo, RT + PSCT
Chemotherapy, Radiation Therapy, and Peripheral Stem Cell Transplantation
干预措施: Thiotepa (Drug)
Chemo, RT + PSCT
Chemotherapy, Radiation Therapy, and Peripheral Stem Cell Transplantation
干预措施: Allogeneic bone marrow transplantation (Procedure)
Chemo, RT + PSCT
Chemotherapy, Radiation Therapy, and Peripheral Stem Cell Transplantation
干预措施: In vitro-treated peripheral blood stem cell transplantation (PBSCT) (Procedure)
Chemo, RT + PSCT
Chemotherapy, Radiation Therapy, and Peripheral Stem Cell Transplantation
干预措施: Radiation Therapy (RT) (Radiation)
结局指标
主要结局
Maximum Tolerated Dose (MTD) of T-cells photochemically treated with psoralen and ultraviolet A
时间窗: 100 days
MTD defined as dose preceding that at which at least 2 of 3 patients experience dose limiting toxicities. Patients followed for 100 days.
次要结局
未报告次要终点