NCT01622556终止2 期
Phase II Trial of Reduced Intensity Conditioning (RIC) and Allogeneic Transplantation of Umbilical Cord Blood (UCB) From Unrelated Donors in Patients With Hematologic Malignancies
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Event Free Survival
研究概览
简要总结
This is a phase II study to assess the day 180 event free and overall survival after administration of a specified combination of fludarabine, busulfan, Total Body Irradiation (TBI), and thymoglobulin reduced intensity conditioning and 2 unit UCB stem cell transplant in a single institution setting in patients with hematologic malignancies for whom allogeneic transplantation is indicated.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects 18-70 years old. ECOG 0-2
- •Patients must have a diagnosis of one of the following:
- •Chronic Myeloid Leukemia
- •Acute Myeloid Leukemia
- •Acute Lymphoblastic Leukemia
- •Hodgkin's Disease
- •Non-Hodgkins Lymphoma
- •Myelodysplastic Syndromes
- •Myeloproliferative Disorder
- •Patients must have adequate visceral organ function
- •Patients must furnish written informed consent and HIPAA authorization for release of personal health information.
- •Patients must be able to understand the requirements of the study, abide by the study restrictions, and agree to return for the required assessments.
排除标准
- •Patients who have a histocompatible sibling-matched donor age 18 to 65 years in good health who is willing to donate stem cells are ineligible.
- •Patients who are pregnant are ineligible.
- •Patients are ineligible if they have received cumulative chemotherapy doses in excess of: carmustine (BCNU) 400 mg/m2, and/or a cumulative anthracycline exposure in excess of 550 mg/m2 doxorubicin (Adriamycin®) unless gated-pool radionuclide cardiac scan shows greater than/equal to 45% ejection fraction.
- •Patients who are HIV or HTLV-I, -II antibody sero-positive are ineligible.
研究组 & 干预措施
Reduced Intensity Conditioning with UCB Transplant
Experimental
干预措施: Fludarabine (Drug)
Reduced Intensity Conditioning with UCB Transplant
Experimental
干预措施: Busulfan (Drug)
Reduced Intensity Conditioning with UCB Transplant
Experimental
干预措施: Thymoglobulin (Drug)
Reduced Intensity Conditioning with UCB Transplant
Experimental
干预措施: Total Body Irradiation (Radiation)
Reduced Intensity Conditioning with UCB Transplant
Experimental
干预措施: Umbilical Cord Blood (Biological)
结局指标
主要结局
Event Free Survival
时间窗: 180 days
Number of subjects surviving with no events at 180 days post transplantation (Day 0).
次要结局
- Transplant Engraftment(Day 42)
- Incidence of Graft-versus-host disease (GVHD)(1 year)
- Time course for peripheral blood chimerism.(56 days)
- Incidence of secondary lymphoproliferative diseases(6 months)
- Incidence of disease recurrence(Up to two years)
- Incidence of serious infectious complications(1 year)
- Overall Survivals(60 months)
研究者
Amer Beitinjaneh, MD
Assistant Professor of Medicine, Medical Director Stem Cell Transplant Unit
University of Virginia
研究点 (1)
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