Busulfan and Cyclophosphamide Followed By Allogeneic Hematopoietic Cell Transplantation In Patients With Hematological Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Counts of Participants With Disease Free Survival
研究概览
简要总结
This is a treatment guideline to allow routine clinical data to be collected and maintained in Oncore (clinical database) and the University of Minnesota Blood and Marrow Database as part of the historical database maintained by the department.
详细描述
This is a single arm trial to evaluate the efficacy of busulfan and cyclophosphamide followed by an allogeneic hematopoietic stem cell transplant (HSCT) in the treatment of hematological malignancies. The intent of this study is to provide a protocol that will use unmanipulated allogeneic hematopoietic stem cells from related and unrelated donors after a common preparative regimen.
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
- — 至 44 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) and current in complete remission meeting one of the following:
- •<45 years of age who are at least 6 months after initial hematopoietic stem cell transplant (HSCT)
- •<45 years of age and have received sufficient radiation treatment to be ineligible for total body irradiation (TBI) containing preparative therapy
- •Karnofsky performance status >70% or if <16 years of age, a Lansky play score >50
- •Adequate major organ function including:
- •cardiac: left ventricular ejection fraction >45% by echocardiogram (ECHO/MUGA)
- •renal: creatinine clearance >40 mL/min/1.73m^2
- •hepatic: no clinical evidence of hepatic failure (e.g., coagulopathy, ascites)
- •An acceptable source of stem cells according to current University of Minnesota Bone Marrow Transplant program guidelines. Acceptable stem cell sources include:
- •HLA-matched related or unrelated donor bone marrow (6/6 or 5/6 antigen match)
- •HLA-matched related or unrelated donor peripheral blood stem cells
- •related or single or double unrelated donor umbilical cord blood (6/6, 5/6 or 4/6 match)
- •Women of childbearing age must have a negative pregnancy test and all sexually active participants must agree to use effective contraception during study treatment
- •Written consent (adult or parent/guardian)
排除标准
- •eligible for TBI containing preparative regimen
- •active uncontrolled infection within one week of study enrollment
- •pregnant or lactating female
研究组 & 干预措施
Allogeneic Hematopoietic Stem Cell Transplant
Patients treated with Allopurinol, Keppra, Busulfan, Cyclophosphamide, Filgrastim, antithymocyte globulin, Tacrolimus, Mycophenolate mofetil and allogeneic hematopoietic stem cell transplant infusion.
干预措施: Keppra (Drug)
Allogeneic Hematopoietic Stem Cell Transplant
Patients treated with Allopurinol, Keppra, Busulfan, Cyclophosphamide, Filgrastim, antithymocyte globulin, Tacrolimus, Mycophenolate mofetil and allogeneic hematopoietic stem cell transplant infusion.
干预措施: Allopurinol (Drug)
Allogeneic Hematopoietic Stem Cell Transplant
Patients treated with Allopurinol, Keppra, Busulfan, Cyclophosphamide, Filgrastim, antithymocyte globulin, Tacrolimus, Mycophenolate mofetil and allogeneic hematopoietic stem cell transplant infusion.
干预措施: Busulfan (Drug)
Allogeneic Hematopoietic Stem Cell Transplant
Patients treated with Allopurinol, Keppra, Busulfan, Cyclophosphamide, Filgrastim, antithymocyte globulin, Tacrolimus, Mycophenolate mofetil and allogeneic hematopoietic stem cell transplant infusion.
干预措施: Cyclophosphamide (Drug)
Allogeneic Hematopoietic Stem Cell Transplant
Patients treated with Allopurinol, Keppra, Busulfan, Cyclophosphamide, Filgrastim, antithymocyte globulin, Tacrolimus, Mycophenolate mofetil and allogeneic hematopoietic stem cell transplant infusion.
干预措施: Tacrolimus (Drug)
Allogeneic Hematopoietic Stem Cell Transplant
Patients treated with Allopurinol, Keppra, Busulfan, Cyclophosphamide, Filgrastim, antithymocyte globulin, Tacrolimus, Mycophenolate mofetil and allogeneic hematopoietic stem cell transplant infusion.
干预措施: Mycophenolate mofetil (Drug)
Allogeneic Hematopoietic Stem Cell Transplant
Patients treated with Allopurinol, Keppra, Busulfan, Cyclophosphamide, Filgrastim, antithymocyte globulin, Tacrolimus, Mycophenolate mofetil and allogeneic hematopoietic stem cell transplant infusion.
干预措施: Allogeneic hematopoietic stem cell transplant (Biological)
Allogeneic Hematopoietic Stem Cell Transplant
Patients treated with Allopurinol, Keppra, Busulfan, Cyclophosphamide, Filgrastim, antithymocyte globulin, Tacrolimus, Mycophenolate mofetil and allogeneic hematopoietic stem cell transplant infusion.
干预措施: Filgrastim (Biological)
Allogeneic Hematopoietic Stem Cell Transplant
Patients treated with Allopurinol, Keppra, Busulfan, Cyclophosphamide, Filgrastim, antithymocyte globulin, Tacrolimus, Mycophenolate mofetil and allogeneic hematopoietic stem cell transplant infusion.
干预措施: antithymocyte globulin (Biological)
结局指标
主要结局
Counts of Participants With Disease Free Survival
时间窗: 2 Years
The length of time after treatment ends that a patient survives without any signs or symptoms of that cancer or any other type of cancer. In a clinical trial, measuring the disease-free survival is one way to see how well a new treatment works. Patients with leukemia involving the BM and myelodysplastic syndrome will have this assessed by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients will also have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated.
Count of Participants With Disease Free Survival
时间窗: 7 Years
The length of time after treatment ends that a patient survives without any signs or symptoms of that cancer or any other type of cancer. In a clinical trial, measuring the disease-free survival is one way to see how well a new treatment works. Patients with leukemia involving the BM and myelodysplastic syndrome will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients will also have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated.
次要结局
- Percentage of Participants With Treatment-Related Toxicity(1 year)
- Number of Participant Who Were Alive at 5 Years Post Transplant(5 Years)
- Percentage of Participants With Acute Graft-Versus-Host Disease by Grade(Day 100)
- Percentage of Participants With Engraftment Failure(Day 42)
- Number of Participant Who Were Alive at 2 Years Post Transplant(2 Years)
- Count of Participants Who Achieved Neutrophil Engraftment(By Day 42)
- Percentage of Participants With Chronic Graft-Versus-Host Disease(1 Year)
- Percentage of Participants With Relapse(2 Years)
- Number of Participant Who Were Alive at 7 Years Post Transplant(7 Years)