NCT02385955Unknown2 期
Prospective Multicenter Phase II Study of Myeloablative Double Unit Umbilical Cord Blood Transplantation in Adult Patients With Hematologic Malignancies
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 39
- 主要终点
- Overall survival
研究概览
简要总结
This study aimed to evaluate the efficacy and safety of myeloablative double unit umbilical cord blood transplantation (dUCBT) in adult patients with hematologic malignancies. Two myeloablative conditioning regimens will be used in this study: (1) total body irradation (TBI), cyclophosphamide, and cytarabine, or (2) thiotepa, busulfan, and fludarabine.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with hematologic malignancies requiring hematopoietic stem cell transplantation: (1) high risk acute myeloid leukemia in remission, (2) high risk acute lymphoblastic leukemia in remission, or (3) IPSS intermediate-2, high, or transfusion-dependent myelodysplastic syndrome
- •Patients who have suitable cord blood units for dUCBT
- •Patients with ECOG performance status 0-1
- •Patients with adequate organ function: lung, kidney, liver, heart, etc.
- •Informed consent
排除标准
- •Patients who can receive hematopoietic stem cell transplantation from HLA-matched sibling or unrelated donors
- •Patients who have anti-HLA antibodies
- •Patients with any evidence of central nervous system (CNS) involvement of disease
- •Patients with uncontrolled diabetes
- •Patients with uncontrolled hypertension
- •Patients with any evidence of active infection
- •Positive for human immunodeficiency virus (HIV)
- •Previous history of other malignancy within 5 years (Basal cell carcinoma of skin, cervical carcinoma in situ, and differentiated thyroid carcinoma with curative resection are permitted.)
- •Women who are pregnant or breastfeeding
- •Patients with previous history of allogeneic stem cell transplantation
- •Patients with major psychotic disorder or drug/alcohol abuser
- •Inappropriate patients according to the investigators' opinion
结局指标
主要结局
Overall survival
时间窗: 2 years
次要结局
- Chronic graft-versus-host disease(2 years)
- Non-relapse mortality(2 years)
- Time to relapse or progression(2 years)
- Acute graft-versus-host disease(2 years)
- Time to engraftment(2 years)
- Progression-free survival(2 years)
- Other transplant-related serious adverse events(2 years)
研究者
Sung-Soo Yoon
Professor
Seoul National University Hospital
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