A Phase II Study of Reduced Intensity Double Umbilical Cord Blood Transplantation Using Fludarabine, Melphalan, and Low Dose Total Body Radiation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 3
- 主要终点
- Number of Participants With a Clinically Significant Infection
研究概览
简要总结
This trial will use two cord blood units for transplantation using a reduced intensity regimen rather than using intense doses of chemotherapy and radiation therapy. Two cord blood units (double cord blood) are being used, as the numbers of blood cells in one unit are too few to allow successful growth of these cells.
Because the risk of infection, particularly virus infection, is high after double cord blood transplant, this study seeks to reduce the rise of virus infection by using a reduced intensity regimen without a medicine called antithymocyte globulin (ATG), as used in prior cord blood transplants. Subjects will receive two chemotherapy drugs, melphalan and fludarabine, and low dose of total body radiation (one treatment) instead of the ATG. The number of patients with virus infections in this study will be compared to our prior experience using the ATG.
详细描述
Subjects will receive their transplants as in-patients.
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IV-Catheter
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one or two IV catheters will be placed on the day of hospital admission
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Conditioning
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Fludarabine IV six days before transplant (days -7, -6, -5. -4, -3, -2)
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Melphalan IV (day -1)
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Total body radiation on day 0 (same day as transplant)
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Immunosuppressive Therapy
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Tacrolimus and sirolimus beginning day -3, daily for 6-9 months post-transplant. Given IV as in-patient, orally as out-patient
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Infusion of Cord Blood units
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
- •Hematologic malignancy for whom allogeneic stem cell transplantation is deemed clinically appropriate
- •Appropriate candidate for reduced intensity regimen, according to the treating physician
- •Lack of 6/6/ or 5/6 HLA-matched related, 8/8/ HLA-matched unrelated donor, or unrelated donor not available with a time frame necessary to perform a potentially curative stem cell transplant
- •Able to comply with the requirements for care after allogeneic stem cell transplantation
排除标准
- •Cardiac disease: symptomatic congestive heart failure or evidence of left ventricular dysfunction
- •Pulmonary disease: symptomatic chronic obstructive lung disease, symptomatic restrictive lung disease
- •Renal disease
- •Hepatic disease
- •Neurologic disease: symptomatic leukoencephalopathy, active CNS malignancy or other neuropsychiatric abnormalities believed to preclude transplantation
- •HIV-positive
- •Uncontrolled infection
- •Pregnant or breast-feeding
研究组 & 干预措施
Fludarabine/Melphalan/TBI
All patients receive same therapy
干预措施: Fludarabine (Drug)
Fludarabine/Melphalan/TBI
All patients receive same therapy
干预措施: Melphalan (Drug)
Fludarabine/Melphalan/TBI
All patients receive same therapy
干预措施: Total Body Radiation (Radiation)
Fludarabine/Melphalan/TBI
All patients receive same therapy
干预措施: Cord Blood (Biological)
结局指标
主要结局
Number of Participants With a Clinically Significant Infection
时间窗: 1 Year
The one year significant infection rate (infections requiring medical intervention) after double umbilical cord blood transplant using a novel conditioning regimen of fludarabine/melphalan/low dose total body radiation. The data is shown as the number of significant infections participants experienced during the first year, measured from the start of treatment.
次要结局
- Relapse-free Survival(2 years)
- Number of Participants With Primary Graft Failure(From the time of transplantation until 42 days post transplantation)
- Overall Survival(2 years)
- Median Time to Neutrophil Engraftment(From the time of transplantation, until the time of neutrophil engraftment, median duration of 24 days)
- Median Time to Platelet Engraftment(From the time of transplantation, until the time of platelet engraftment, median duration of 52 days)
- Rates of Grade II-IV and Grade III-IV Acute Graft Versus Host Disease (GVHD) at 100 Days(100 Days)
- The Rate of Chronic GVHD(From the time of transplantation until the time of chronic GVHD onset, up to 1 year)
- Immune Reconstitution - Median CD4 Count at 12 Months(1 Year)
- 100-day Treatment Related Mortality(100 Days)
- 1 Year Relapse Rate(1 year)
- Rate of Post-transplant Lymphoma(2.5 years)
- Median Thrombopoietin Levels After Transplant(30 Days)
研究者
Zachariah Michael DeFilipp
Hematology/Oncology
Massachusetts General Hospital