NCT00514579已完成2 期
A Phase II Multicenter Trial of Myeloablative Double Unit Umbilical Cord Blood Transplantation (UCBT) in Adults With Hematologic Malignancy
Center for International Blood and Marrow Transplant Research19 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2007年8月最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 19
- 主要终点
- Measure overall survival of double unit UCBT in adult patients with hematologic malignancies
研究概览
简要总结
The hypothesis of the study is double unit umbilical cord blood transplantation in adults will be associated with a one year survival rate of at least 40%.
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
- 22 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 22 - 50 years
- •Patients will have one of the following hematological malignancies:
- •Acute myelogenous leukemia (AML): Complete first remission (CR1) at high risk for relapse or Complete second remission (CR2)
- •Acute lymphoblastic leukemia (ALL): Complete first remission (CR1) at high risk for relapse or Complete second remission (CR2)
- •Acute undifferentiated leukemia (AUL) or biphenotypic leukemia: CR1 or CR2
- •Myelodysplastic Syndrome (MDS) with one of the following: Low and Intermediate-1 International Prognostic Scoring System (IPSS) score with Life-threatening neutropenia or thrombocytopenia; or Platelet transfusion dependence Intermediate-2 or High IPSS score Therapy-related disease: patient with history of chemotherapy and current evidence of MDS
- •Patients with adequate organ function and performance status criteria
- •Two Suitable Umbilical Cord Blood Units: a cryopreserved dose of at least 1.5 x 107 TNC/kg. If the unit contains red cells at time of cryopreservation, the cryopreserved dose must be at least 2.0 x 107 TNC/kg. Each unit must be at least 4/6 HLA-A and B antigen, and DRB1 allele matched with the recipient. Each unit must be at least 3/6 HLA-A, B DRB1 antigen matched to each other.
排除标准
- •Patient with suitable related donor
- •AML, ALL, AUL, biphenotypic leukemia beyond CR2
- •AML evolved from myelofibrosis
- •Any acute leukemia with:
- •Morphologic relapse or persistent disease in the BM
- •Active extra-medullary leukemia including active CNS leukemia
- •Requiring greater than two cycles of chemotherapy to obtain present remission status
- •Bone marrow aplasia (defined as BM cellularity < 5% at transplant work-up)
- •MDS with 10% or greater bone marrow blasts at pre-transplant workup
- •Prior autologous or allogeneic HSC transplant at any time
- •Prior radiation therapy rendering patient ineligible for TBI
- •Any uncontrolled infection at time of study enrollment
- •Seropositive or NAT positive for HIV or HTLV1
- •Females who are pregnant or breast feeding
- •Patient unable to give informed consent or unable to comply with the treatment protocol including appropriate supportive care, follow-up, and research tests
结局指标
主要结局
Measure overall survival of double unit UCBT in adult patients with hematologic malignancies
时间窗: One year
次要结局
- Measure incidence of donor-derived neutrophil and platelet recovery(100 Days)
- Measure contribution of each unit to initial and sustained engraftment(2 years)
- Measure incidence and severity of acute graft-versus-host disease(100 Days)
- Measure incidence and severity of chronic GVHD(1 year)
- Measure incidence of transplant-related mortality(6 months)
- Measure incidence of malignant relapse(2 years)
- Measure incidence of serious infectious complications(1 year)
- Measure incidence of immune reconstitution(2 years)
- Measure probability of overall and disease-free survival(2 years)
研究者
研究点 (19)
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