Allogeneic Transplant for Hematological Malignancy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- Number of Participants Experiencing Disease-Free Survival at 2 Years Post Transplant
研究概览
简要总结
The purpose of this study is to develop a standard of care treatment using allogeneic stem cells for patients with cancers of the blood.
The protocol was revised to reflect that this study is considered "treatment guidelines", rather than a research study.
详细描述
Preparative regimen using total body irradiation (TBI) and cyclophosphamide:
- on day -6 and -5: cyclophosphamide is given,
- on day -4, -3, -2, and -1: TBI is given,
- on day 0: stem cell or bone marrow is infused.
Alternate preparative therapy for patients not able to receive TBI
The chemotherapy (cyclophosphamide and busulfan) is given with the intent of destroying the bone marrow, eliminating any cancerous and preparing for the transplant of the donor's blood stem cells by suppressing the immune system.
l. Ten days before the transplant (Day 10), subjects will be admitted to the bone marrow transplant unit and placed in isolation to reduce exposure to infections. Isolation will be continued until adequate numbers of cells are present in the blood to fight infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Donor will be <75 years of age and in good health.
- •Recipients will be < or = 55 years, will have normal organ function (excluding bone marrow) and will have a Karnofsky activity assessment > or = 90%.
- •Recipients with related or unrelated donor matched at the HLA A, B, DRB1 loci, or mismatched related or unrelated (if < 35 years old) at a single HLA A, B, DRB1 locus.
- •Recipients will be eligible in one of the following disease categories
- •Chronic myelogenous leukemia in accelerated phase or in post blast crisis second or greater chronic phase; or in chronic phase but intolerant of or resistant to tyrosine kinase inhibitors.
- •Acute myelocytic leukemia in first or greater remission, or first, second or third relapse.
- •Acute lymphocytic leukemia in the 2nd or greater bone marrow remission.
- •High risk children will be transplanted in first remission if they meet criteria
- •Myelodysplastic syndrome.
- •Myeloproliferative Diseases - (i.e. myelofibrosis, chronic myelomonocytic leukemia (CMML))
- •Juvenile myelomonocytic leukemia
- •Chronic lymphocytic leukemia
- •Advanced non-Hodgkin's (NHL).
- •Advanced Hodgkin's disease beyond PR2 (> CR3, > PR3).
- •Multiple Myeloma after initial therapy.
- •Donors and recipients signed informed consent
- •Exclusion Criteria
- •donors and recipients should meet the following test criteria.
- •required for donors:
- •anti-HIV, Hepatitis B, surface antigen, anti-HCV, CMV, HSV, EBV serologies, pre-priming.
- •CBC, platelet count each day of apheresis, day 0 (or 1 or 2 as needed)
- •required for recipients:
- •anti-HIV, Hepatitis B, surface antigen, anti-HCV, CMV, HSV, EBV serologies, pre-transplant.
排除标准
- 未提供
研究组 & 干预措施
PBSC: No TBI
Patients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Peripheral Blood Stem Cells (PBSC) as a source of transplant
干预措施: Stem Cell Transplant (Biological)
PBSC: No TBI
Patients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Peripheral Blood Stem Cells (PBSC) as a source of transplant
干预措施: Cyclophosphamide (Drug)
PBSC: No TBI
Patients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Peripheral Blood Stem Cells (PBSC) as a source of transplant
干预措施: Busulfan (Drug)
Marrow : No TBI
Patients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Bone Marrow as a source of stem cell transplant
干预措施: Stem Cell Transplant (Biological)
Marrow : No TBI
Patients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Bone Marrow as a source of stem cell transplant
干预措施: Cyclophosphamide (Drug)
Marrow : No TBI
Patients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Bone Marrow as a source of stem cell transplant
干预措施: Busulfan (Drug)
UCB : No TBI
Patients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Umbilical Cord Blood (UCB) as a source of stem cell transplant
干预措施: Stem Cell Transplant (Biological)
UCB : No TBI
Patients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Umbilical Cord Blood (UCB) as a source of stem cell transplant
干预措施: Cyclophosphamide (Drug)
UCB : No TBI
Patients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Umbilical Cord Blood (UCB) as a source of stem cell transplant
干预措施: Busulfan (Drug)
UCB : No TBI/Bu/Cy/ATG
Patients who receives Umbilical Cord Blood (UCB) as a source of transplant and who have not had chemotherapy in the prior 3 months receives ATG in addition to cyclophosphamide, Busulfan preparative regimen
干预措施: Stem Cell Transplant (Biological)
UCB : No TBI/Bu/Cy/ATG
Patients who receives Umbilical Cord Blood (UCB) as a source of transplant and who have not had chemotherapy in the prior 3 months receives ATG in addition to cyclophosphamide, Busulfan preparative regimen
干预措施: Cyclophosphamide (Drug)
UCB : No TBI/Bu/Cy/ATG
Patients who receives Umbilical Cord Blood (UCB) as a source of transplant and who have not had chemotherapy in the prior 3 months receives ATG in addition to cyclophosphamide, Busulfan preparative regimen
干预措施: Busulfan (Drug)
UCB : No TBI/Bu/Cy/ATG
Patients who receives Umbilical Cord Blood (UCB) as a source of transplant and who have not had chemotherapy in the prior 3 months receives ATG in addition to cyclophosphamide, Busulfan preparative regimen
干预措施: Equine ATG (ATGAM) (Drug)
PBSC
Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplant
干预措施: Stem Cell Transplant (Biological)
PBSC
Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplant
干预措施: Cyclophosphamide (Drug)
PBSC
Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplant
干预措施: Total Body Irradiation (Radiation)
Marrow
Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplant
干预措施: Stem Cell Transplant (Biological)
Marrow
Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplant
干预措施: Cyclophosphamide (Drug)
Marrow
Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplant
干预措施: Total Body Irradiation (Radiation)
UCB
Patients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplant
干预措施: Stem Cell Transplant (Biological)
UCB
Patients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplant
干预措施: Cyclophosphamide (Drug)
UCB
Patients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplant
干预措施: Total Body Irradiation (Radiation)
Co-Enroll From MT0403
Patients receiving cyclophosphamide, Total Body Irradiation (TBI) , CD4+CD25+ and Peripheral Blood Stem Cells (PBSC) as a source of transplant. These patients are co-enrolled on the MT2004-03 trial (NCT00725062)
干预措施: Stem Cell Transplant (Biological)
Co-Enroll From MT0403
Patients receiving cyclophosphamide, Total Body Irradiation (TBI) , CD4+CD25+ and Peripheral Blood Stem Cells (PBSC) as a source of transplant. These patients are co-enrolled on the MT2004-03 trial (NCT00725062)
干预措施: Cyclophosphamide (Drug)
Co-Enroll From MT0403
Patients receiving cyclophosphamide, Total Body Irradiation (TBI) , CD4+CD25+ and Peripheral Blood Stem Cells (PBSC) as a source of transplant. These patients are co-enrolled on the MT2004-03 trial (NCT00725062)
干预措施: Total Body Irradiation (Radiation)
Co-Enroll From MT0403
Patients receiving cyclophosphamide, Total Body Irradiation (TBI) , CD4+CD25+ and Peripheral Blood Stem Cells (PBSC) as a source of transplant. These patients are co-enrolled on the MT2004-03 trial (NCT00725062)
干预措施: CD4+/CD25+ cells (Biological)
结局指标
主要结局
Number of Participants Experiencing Disease-Free Survival at 2 Years Post Transplant
时间窗: 2 years
Disease-Free Survival is the length of time during and after medication or treatment during which the disease being treated (usually cancer) does not get worse. It is sometimes used as a metric to study the health of a person with a disease to try to determine how well a new treatment is working.
Number of Participants Experiencing Disease-Free Survival at 5 Years Post Transplant
时间窗: 5 years
Disease-Free Survival is the length of time during and after medication or treatment during which the disease being treated (usually cancer) does not get worse. It is sometimes used as a metric to study the health of a person with a disease to try to determine how well a new treatment is working.
次要结局
- Number of Participants With Persistence or Relapse of Malignancy at 2 Years Post Transplant(2 years)
- Number of Participants With Persistence or Relapse of Malignancy at 5 Years Post Transplant(5 years)
- Number of Participants Who Were Alive at 2 Year Post Transplant(2 years)
- Number of Participants Who Were Alive at 5 Year Post Transplant(5 years)
- Number of Participants With Chronic Graft-Versus-Host Disease(1 year)
- Number of Participants With Neutrophil Engraftment(Day 42)
- Number of Participants With Acute Graft-versus-host Disease (GVHD)(Day 100)
- Number of Participants Experiencing Engraftment Failure(Day 42)