Transplantation Using Umbilical Cord And Placental Blood
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
RATIONALE: Umbilical cord blood or placental blood transplantation may be able to replace immune cells that were destroyed by the chemotherapy or radiation therapy that was used to kill cancer cells.
PURPOSE: Phase II trial to study the effectiveness of umbilical cord blood and placental blood transplantation in treating patients who have hematologic cancer or aplastic anemia.
详细描述
OBJECTIVES:
- Determine the response rate of patients with chronic myeloid leukemia, acute leukemia, lymphoma, myeloma, myelodysplasia, aplastic anemia, Fanconi's anemia, histiocytosis, hereditary immunodeficiency, or storage disorder treated with allogeneic umbilical cord and placental blood transplantation.
- Determine the toxicity of this regimen in these patients.
- Determine survival in these patients treated with this regimen.
- Determine the incidence of graft-versus-host disease in these patients treated with this regimen.
OUTLINE: Patients receive a standard preparative regimen for their disease. Following the preparative regimen patients undergo umbilical cord blood stem cell transplantation on day 0.
Patients are followed every 1-2 weeks for 6 months.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 4-5 years.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- — 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of chronic myeloid leukemia, acute leukemia, lymphoma, myeloma, myelodysplasia, aplastic anemia, Fanconi's anemia, histiocytosis, hereditary immunodeficiency, or storage disorder
- •Eligible for allogeneic bone marrow transplantation, but lacking a donor
- •Available donor umbilical cord blood that is mismatched on no more than 2 HLA loci
- •HIV negative
- •Hepatitis B surface antigen and hepatitis C negative
- •PATIENT CHARACTERISTICS:
- •Under physiologic 60
- •Performance status:
- •Not specified
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •Bilirubin less than 2 times normal
- •No severe hepatic disease
- •Hepatitis B surface antigen and hepatitis C negative
- •Creatinine less than 2 times normal
- •HIV negative
- •Not pregnant or nursing
- •No other serious medical or psychiatric illness that would preclude study compliance
- •No serious infection
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •Not specified
- •Not specified
排除标准
- 未提供
结局指标
主要结局
Response rate
Toxicity
Survival
Incidence of graft-versus-host disease
次要结局
未报告次要终点