A Phase I Study of Reduced Intensity, Sequential Double Umbilical Cord Blood Transplantation Using ProHema Modulated Umbilical Cord Blood Units in Subjects With Hematological Malignancies.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Determine the safety of ProHema modulated umbilical cord blood units when used for transplantation in a reduced intensity, sequential umbilical cord blood transplantation model.
研究概览
简要总结
The purpose of this research study is to determine the safety and efficacy of a reduced intensity conditioning regimen during a double umbilical cord blood unit transplant with one of the cord blood units modulated with ProHema.
详细描述
The purpose of this research study is to determine the safety and efficacy of a reduced intensity conditioning regimen during a double umbilical cord blood unit transplant with one of the cord blood units modulated with ProHema.
-As part of this research study cord units will be modulated in the laboratory with ProHema before it is given to the participant. Two different treatment groups will be tested. Group 1: will have the second cord blood unit modulated with ProHema; Group 2: will have the first cord blood unit modulated with ProHema.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 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 for whom allogeneic stem cell transplantation is deemed clinically appropriate
- •Patient must be ineligible for traditional myeloablative transplantation according to treating physician
- •Lack of 6/6 or 5/6 HLA-matched related, 8/8 HLA-matched unrelated donor, or unrelated donor not available within a time frame necessary to perform a potentially curative stem cell transplant
- •18-65 years of age
- •ECOG Performance Status 0-2
排除标准
- •The following hematologic malignancies are excluded:
- •Myelofibrosis unless there has been exposure to cytotoxic chemotherapy for the treatment of progression to acute myeloid leukemia
- •Chronic Myelogenous Leukemia, unless there has been exposure to cytotoxic chemotherapy for the treatment of blast phase, 3) Aplastic anemia, in the absence of transformation to Myelodysplastic disorder
- •Cardiac disease: symptomatic congestive heart failure or evidence of left ventricular dysfunction as measured by gated radionucleotide ventriculogram or echocardiogram; active angina pectoris, or uncontrolled hypertension
- •Pulmonary disease: symptomatic chronic obstructive lung disease, symptomatic restrictive lung disease, or corrected DLCO of < 50% of predicted, corrected hemoglobin
- •Renal disease: serum creatinine > 2.0mg/dl
- •Hepatic disease: serum bilirubin > 2.0mg/dl (expect in the case of Gilbert's syndrome or ongoing hemolytic anemia), SGOT or SGPT > 3 x upper limit of normal
- •Neurologic disease: symptomatic leukoencephalopathy, active CNS malignancy or other neuropsychiatric abnormalities believed to preclude transplantation
- •HIV antibody
- •Uncontrolled infection
- •Pregnancy or breast feeding mother
- •Inability to comply with the requirements for care after allogeneic stem cell transplantation
研究组 & 干预措施
Group 1
2 umbilical cord units: Second cord blood unit modulated with ProHema
干预措施: Fludarabine (Drug)
Group 1
2 umbilical cord units: Second cord blood unit modulated with ProHema
干预措施: Melphalan (Drug)
Group 1
2 umbilical cord units: Second cord blood unit modulated with ProHema
干预措施: Antithymocyte Globulin (Drug)
Group 1
2 umbilical cord units: Second cord blood unit modulated with ProHema
干预措施: Sirolimus (Drug)
Group 1
2 umbilical cord units: Second cord blood unit modulated with ProHema
干预措施: Tacrolimus (Drug)
Group 2
2 umbilical cord units: First cord blood unit modulated with ProHema
干预措施: Fludarabine (Drug)
Group 2
2 umbilical cord units: First cord blood unit modulated with ProHema
干预措施: Melphalan (Drug)
Group 2
2 umbilical cord units: First cord blood unit modulated with ProHema
干预措施: Antithymocyte Globulin (Drug)
Group 2
2 umbilical cord units: First cord blood unit modulated with ProHema
干预措施: Sirolimus (Drug)
Group 2
2 umbilical cord units: First cord blood unit modulated with ProHema
干预措施: Tacrolimus (Drug)
结局指标
主要结局
Determine the safety of ProHema modulated umbilical cord blood units when used for transplantation in a reduced intensity, sequential umbilical cord blood transplantation model.
时间窗: 2 years
次要结局
- Time to engraftment of umbilical cord blood units(2 years)
- Fractional chimerism of transplanted cord blood units(2 years)
- Rates of acute and chronic GVHD(2 years)
- 30- and 100-day treatment related mortality(2 years)
- Measures of immune reconstitution and relapse-free and overall survival at 1 and 2 years after transplantation(2 years)