Allogeneic Transplant for Hematological Malignancy
Overview
- Phase
- Not Applicable
- Intervention
- Stem Cell Transplant
- Conditions
- Leukemia, Myeloid, Chronic
- Sponsor
- Masonic Cancer Center, University of Minnesota
- Enrollment
- 330
- Locations
- 1
- Primary Endpoint
- Number of Participants Experiencing Disease-Free Survival at 2 Years Post Transplant
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Detailed Description
Preparative regimen using total body irradiation (TBI) and cyclophosphamide: 1. on day -6 and -5: cyclophosphamide is given, 2. on day -4, -3, -2, and -1: TBI is given, 3. 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. 2. On day -9, -8, -7, -6 busulfan is given. 3. On day -5, -4, -3, -2 cyclophosphamide is given. 4. On day -1 no therapy is given (day of rest). 5. On day 0 the donor stem cells are given intravenously. Additional cells may be given on day +1 or 2 as needed. Transplant: Subjects will be admitted to the bone marrow transplant unit and put in isolation to reduce exposure to infectious agents. During this time, they will receive the preparative treatment outlined above. Once they have received the preparative regimen, stem cells will be obtained from the donor and given intravenously. The new stem cells will replace the bone marrow that was damaged by the treatment for the cancer. Isolation will be continued until adequate numbers of cells are present in the blood to fight infection. Subjects will then be transferred from the bone marrow transplant unit and discharged from the hospital when medically ready. Subjects will be expected to return for follow-up to the bone marrow transplant clinic at specific dates as determined by their physician.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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))
Exclusion Criteria
- Not provided
Arms & Interventions
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
Intervention: Stem Cell Transplant
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
Intervention: Cyclophosphamide
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
Intervention: Busulfan
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
Intervention: Stem Cell Transplant
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
Intervention: Cyclophosphamide
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
Intervention: Busulfan
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
Intervention: Stem Cell Transplant
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
Intervention: Cyclophosphamide
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
Intervention: Busulfan
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
Intervention: Stem Cell Transplant
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
Intervention: Cyclophosphamide
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
Intervention: Busulfan
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
Intervention: Equine ATG (ATGAM)
PBSC
Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplant
Intervention: Stem Cell Transplant
PBSC
Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplant
Intervention: Cyclophosphamide
PBSC
Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplant
Intervention: Total Body Irradiation
Marrow
Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplant
Intervention: Stem Cell Transplant
Marrow
Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplant
Intervention: Cyclophosphamide
Marrow
Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplant
Intervention: Total Body Irradiation
UCB
Patients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplant
Intervention: Stem Cell Transplant
UCB
Patients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplant
Intervention: Cyclophosphamide
UCB
Patients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplant
Intervention: Total Body Irradiation
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)
Intervention: Stem Cell Transplant
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)
Intervention: Cyclophosphamide
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)
Intervention: Total Body Irradiation
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)
Intervention: CD4+/CD25+ cells
Outcomes
Primary Outcomes
Number of Participants Experiencing Disease-Free Survival at 2 Years Post Transplant
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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)