AML, Hodgkin's Disease, JMML, Leukemia, Lymphocytic, Acute, Leukemia, Lymphocytic, Chronic, Leukemia, Myeloid, Chronic, MDS, Multiple Myeloma, Non-hodgkin's Lymphoma
Conditions
Keywords
stem cell transplant, chronic leukemia, acute leukemia, irradiation, chemotherapy
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.
Interventions
BIOLOGICALStem Cell Transplant
Certain cancers can be treated by giving patients stem cells that come from someone else. This is called a stem-cell transplant. As part of the transplant process, patients receive high doses of chemotherapy and/or radiation to treat their underlying disease, such as cancer. As one of its effects, this treatment also kills the healthy stem cells that are already in the marrow. The transplant provides new stem cells for the patient from a healthy donor; that replace the bone marrow and allow the blood counts to recover. (Allowable sources of stem cells = related or unrelated bone marrow or peripheral blood, for Busulfan/cyclophosphamide/ATG preparative chemo only, umbilical cord blood is also permitted.)
DRUGCyclophosphamide
60 mg/kg intravenously (IV) Days -6 and -5 or 50 mg/kg/day IV Days -5 through -2.
RADIATIONTotal Body Irradiation
On Day -4, -3, -2, -1 total body irradiation is given twice daily.
DRUGBusulfan
When not receiving total body irradiation, administered Days -9 through -6, 0.8 mg/kg/dose by intravenous dosing every 6 hours.
DRUGEquine ATG (ATGAM)
UCB recipients who have not had chemotherapy in the preceding 3 months will also receive Equine ATG (ATGAM) 15 mg/kg IV will be administered every 12 hours for 6 doses beginning on day -3 per institutional guidelines
BIOLOGICALCD4+/CD25+ cells
On days -2, patients will receive CD4+/CD25+ cells intravenously.
Sponsors
Masonic Cancer Center, University of Minnesota
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 55 Years
Healthy volunteers
No
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)) * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing Disease-Free Survival at 2 Years Post Transplant | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Chronic Graft-Versus-Host Disease | 1 year | Chronic Graft-Versus-Host Disease is a severe long-term complication created by infusion of donor cells into a foreign host. Determine the incidence of chronic GVHD 1 year post transplant. Patients will be staged weekly between days 0 and 100 after transplantation using standard criteria. Patients will be assigned an overall GVHD score based on extent of skin rash, volume of diarrhea and maximum bilirubin level. |
| Number of Participants With Persistence or Relapse of Malignancy at 2 Years Post Transplant | 2 years | Defined as the return of disease after its apparent recovery/cessation. Patients with leukemia and lymphoma involving the BM and multiple myeloma will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients with lymphoma and myeloma will 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. |
| Number of Participants With Persistence or Relapse of Malignancy at 5 Years Post Transplant | 5 years | Defined as the return of disease after its apparent recovery/cessation. Patients with leukemia and lymphoma involving the BM and multiple myeloma will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients with lymphoma and myeloma will 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. |
| Number of Participants With Neutrophil Engraftment | Day 42 | Neutrophil engraftment is defined as the first day of three consecutive days where the neutrophil count (absolute neutrophil count) is 500 cells/mm\^3 (0.5 x 10\^9/L) or greater. |
| Number of Participants Who Were Alive at 5 Year Post Transplant | 5 years | The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. |
| Number of Participants Experiencing Engraftment Failure | Day 42 | Graft failure is defined as not accepting donated cells. The donated cells do not make the new white blood cells, red blood cells and platelets. |
| Number of Participants Who Were Alive at 2 Year Post Transplant | 2 years | The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. |
| Number of Participants With Acute Graft-versus-host Disease (GVHD) | Day 100 | Acute Graft-Versus-Host Disease (aGVHD) is a severe short-term complication created by infusion of donor cells into a foreign host. Determine the incidence of grade II-IV acute graft-versus-host disease (GVHD) at day 100 post transplant. Patients will be staged weekly between days 0 and 100 after transplantation using standard criteria used for staging. Patients will be assigned an overall GVHD score based on extent of skin rash, volume of diarrhea and maximum bilirubin level. |
Countries
United States
Participant flow
Pre-assignment details
One patient withdrew consent.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 12 |
| 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 | 13 |
| 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 | 1 |
| 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 | 1 |
| PBSC Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplant | 213 |
| Marrow Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplant | 85 |
| Umbilical Cord Blood Patients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplant | 2 |
| 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) | 2 |
| Total | 329 |
Baseline characteristics
| Characteristic | Total | Marrow : No TBI | UCB : No TBI | UCB : No TBI/Bu/Cy/ATG | PBSC: No TBI | PBSC | Marrow | Umbilical Cord Blood | Co-Enroll From MT0403 |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 76 Participants | 12 Participants | 0 Participants | 0 Participants | 0 Participants | 9 Participants | 51 Participants | 2 Participants | 2 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 253 Participants | 1 Participants | 1 Participants | 1 Participants | 12 Participants | 204 Participants | 34 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 4 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 145 Participants | 11 Participants | 1 Participants | 1 Participants | 5 Participants | 82 Participants | 41 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 179 Participants | 2 Participants | 0 Participants | 0 Participants | 7 Participants | 130 Participants | 40 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 7 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 4 Participants | 3 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 10 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 6 Participants | 4 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 5 Participants | 3 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 31 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 20 Participants | 10 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 272 Participants | 13 Participants | 1 Participants | 1 Participants | 11 Participants | 178 Participants | 64 Participants | 2 Participants | 2 Participants |
| Region of Enrollment United States | 329 participants | 13 participants | 1 participants | 1 participants | 12 participants | 213 participants | 85 participants | 2 participants | 2 participants |
| Sex: Female, Male Female | 130 Participants | 4 Participants | 0 Participants | 1 Participants | 10 Participants | 78 Participants | 35 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 199 Participants | 9 Participants | 1 Participants | 0 Participants | 2 Participants | 135 Participants | 50 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 9 / 12 | 4 / 13 | 1 / 1 | 1 / 1 | 113 / 213 | 31 / 85 | 0 / 2 | 0 / 2 |
| other Total, other adverse events | 12 / 12 | 10 / 13 | 1 / 1 | 1 / 1 | 183 / 213 | 71 / 85 | 2 / 2 | 2 / 2 |
| serious Total, serious adverse events | 3 / 12 | 0 / 13 | 0 / 1 | 0 / 1 | 32 / 213 | 10 / 85 | 0 / 2 | 0 / 2 |
Outcome results
Primary
Number of Participants Experiencing Disease-Free Survival at 2 Years Post Transplant
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.
Time frame: 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PBSC: No TBI | Number of Participants Experiencing Disease-Free Survival at 2 Years Post Transplant | 4 Participants |
| Marrow : No TBI | Number of Participants Experiencing Disease-Free Survival at 2 Years Post Transplant | 9 Participants |
| UCB : No TBI | Number of Participants Experiencing Disease-Free Survival at 2 Years Post Transplant | 0 Participants |
| UCB : No TBI/Bu/Cy/ATG | Number of Participants Experiencing Disease-Free Survival at 2 Years Post Transplant | 0 Participants |
| PBSC | Number of Participants Experiencing Disease-Free Survival at 2 Years Post Transplant | 100 Participants |
| Marrow | Number of Participants Experiencing Disease-Free Survival at 2 Years Post Transplant | 52 Participants |
| Umbilical Cord Blood | Number of Participants Experiencing Disease-Free Survival at 2 Years Post Transplant | 2 Participants |
| Co-Enroll From MT0403 | Number of Participants Experiencing Disease-Free Survival at 2 Years Post Transplant | 2 Participants |
Primary
Number of Participants Experiencing Disease-Free Survival at 5 Years Post Transplant
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.
Time frame: 5 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PBSC: No TBI | Number of Participants Experiencing Disease-Free Survival at 5 Years Post Transplant | 3 Participants |
| Marrow : No TBI | Number of Participants Experiencing Disease-Free Survival at 5 Years Post Transplant | 9 Participants |
| UCB : No TBI | Number of Participants Experiencing Disease-Free Survival at 5 Years Post Transplant | 0 Participants |
| UCB : No TBI/Bu/Cy/ATG | Number of Participants Experiencing Disease-Free Survival at 5 Years Post Transplant | 0 Participants |
| PBSC | Number of Participants Experiencing Disease-Free Survival at 5 Years Post Transplant | 85 Participants |
| Marrow | Number of Participants Experiencing Disease-Free Survival at 5 Years Post Transplant | 48 Participants |
| Umbilical Cord Blood | Number of Participants Experiencing Disease-Free Survival at 5 Years Post Transplant | 2 Participants |
| Co-Enroll From MT0403 | Number of Participants Experiencing Disease-Free Survival at 5 Years Post Transplant | 2 Participants |
Secondary
Number of Participants Experiencing Engraftment Failure
Graft failure is defined as not accepting donated cells. The donated cells do not make the new white blood cells, red blood cells and platelets.
Time frame: Day 42
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PBSC: No TBI | Number of Participants Experiencing Engraftment Failure | 0 Participants |
| Marrow : No TBI | Number of Participants Experiencing Engraftment Failure | 0 Participants |
| UCB : No TBI | Number of Participants Experiencing Engraftment Failure | 0 Participants |
| UCB : No TBI/Bu/Cy/ATG | Number of Participants Experiencing Engraftment Failure | 0 Participants |
| PBSC | Number of Participants Experiencing Engraftment Failure | 1 Participants |
| Marrow | Number of Participants Experiencing Engraftment Failure | 0 Participants |
| Umbilical Cord Blood | Number of Participants Experiencing Engraftment Failure | 0 Participants |
| Co-Enroll From MT0403 | Number of Participants Experiencing Engraftment Failure | 0 Participants |
Secondary
Number of Participants Who Were Alive at 2 Year Post Transplant
The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer.
Time frame: 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PBSC: No TBI | Number of Participants Who Were Alive at 2 Year Post Transplant | 5 Participants |
| Marrow : No TBI | Number of Participants Who Were Alive at 2 Year Post Transplant | 11 Participants |
| UCB : No TBI | Number of Participants Who Were Alive at 2 Year Post Transplant | 0 Participants |
| UCB : No TBI/Bu/Cy/ATG | Number of Participants Who Were Alive at 2 Year Post Transplant | 0 Participants |
| PBSC | Number of Participants Who Were Alive at 2 Year Post Transplant | 122 Participants |
| Marrow | Number of Participants Who Were Alive at 2 Year Post Transplant | 59 Participants |
| Umbilical Cord Blood | Number of Participants Who Were Alive at 2 Year Post Transplant | 2 Participants |
| Co-Enroll From MT0403 | Number of Participants Who Were Alive at 2 Year Post Transplant | 2 Participants |
Secondary
Number of Participants Who Were Alive at 5 Year Post Transplant
The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer.
Time frame: 5 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PBSC: No TBI | Number of Participants Who Were Alive at 5 Year Post Transplant | 3 Participants |
| Marrow : No TBI | Number of Participants Who Were Alive at 5 Year Post Transplant | 9 Participants |
| UCB : No TBI | Number of Participants Who Were Alive at 5 Year Post Transplant | 0 Participants |
| UCB : No TBI/Bu/Cy/ATG | Number of Participants Who Were Alive at 5 Year Post Transplant | 0 Participants |
| PBSC | Number of Participants Who Were Alive at 5 Year Post Transplant | 100 Participants |
| Marrow | Number of Participants Who Were Alive at 5 Year Post Transplant | 54 Participants |
| Umbilical Cord Blood | Number of Participants Who Were Alive at 5 Year Post Transplant | 2 Participants |
| Co-Enroll From MT0403 | Number of Participants Who Were Alive at 5 Year Post Transplant | 2 Participants |
Secondary
Number of Participants With Acute Graft-versus-host Disease (GVHD)
Acute Graft-Versus-Host Disease (aGVHD) is a severe short-term complication created by infusion of donor cells into a foreign host. Determine the incidence of grade II-IV acute graft-versus-host disease (GVHD) at day 100 post transplant. Patients will be staged weekly between days 0 and 100 after transplantation using standard criteria used for staging. Patients will be assigned an overall GVHD score based on extent of skin rash, volume of diarrhea and maximum bilirubin level.
Time frame: Day 100
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PBSC: No TBI | Number of Participants With Acute Graft-versus-host Disease (GVHD) | 6 Participants |
| Marrow : No TBI | Number of Participants With Acute Graft-versus-host Disease (GVHD) | 2 Participants |
| UCB : No TBI | Number of Participants With Acute Graft-versus-host Disease (GVHD) | 1 Participants |
| UCB : No TBI/Bu/Cy/ATG | Number of Participants With Acute Graft-versus-host Disease (GVHD) | 0 Participants |
| PBSC | Number of Participants With Acute Graft-versus-host Disease (GVHD) | 89 Participants |
| Marrow | Number of Participants With Acute Graft-versus-host Disease (GVHD) | 23 Participants |
| Umbilical Cord Blood | Number of Participants With Acute Graft-versus-host Disease (GVHD) | 0 Participants |
| Co-Enroll From MT0403 | Number of Participants With Acute Graft-versus-host Disease (GVHD) | 0 Participants |
Secondary
Number of Participants With Chronic Graft-Versus-Host Disease
Chronic Graft-Versus-Host Disease is a severe long-term complication created by infusion of donor cells into a foreign host. Determine the incidence of chronic GVHD 1 year post transplant. Patients will be staged weekly between days 0 and 100 after transplantation using standard criteria. Patients will be assigned an overall GVHD score based on extent of skin rash, volume of diarrhea and maximum bilirubin level.
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PBSC: No TBI | Number of Participants With Chronic Graft-Versus-Host Disease | 4 Participants |
| Marrow : No TBI | Number of Participants With Chronic Graft-Versus-Host Disease | 2 Participants |
| UCB : No TBI | Number of Participants With Chronic Graft-Versus-Host Disease | 0 Participants |
| UCB : No TBI/Bu/Cy/ATG | Number of Participants With Chronic Graft-Versus-Host Disease | 0 Participants |
| PBSC | Number of Participants With Chronic Graft-Versus-Host Disease | 87 Participants |
| Marrow | Number of Participants With Chronic Graft-Versus-Host Disease | 14 Participants |
| Umbilical Cord Blood | Number of Participants With Chronic Graft-Versus-Host Disease | 0 Participants |
| Co-Enroll From MT0403 | Number of Participants With Chronic Graft-Versus-Host Disease | 1 Participants |
Secondary
Number of Participants With Neutrophil Engraftment
Neutrophil engraftment is defined as the first day of three consecutive days where the neutrophil count (absolute neutrophil count) is 500 cells/mm\^3 (0.5 x 10\^9/L) or greater.
Time frame: Day 42
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PBSC: No TBI | Number of Participants With Neutrophil Engraftment | 11 Participants |
| Marrow : No TBI | Number of Participants With Neutrophil Engraftment | 13 Participants |
| UCB : No TBI | Number of Participants With Neutrophil Engraftment | 0 Participants |
| UCB : No TBI/Bu/Cy/ATG | Number of Participants With Neutrophil Engraftment | 1 Participants |
| PBSC | Number of Participants With Neutrophil Engraftment | 206 Participants |
| Marrow | Number of Participants With Neutrophil Engraftment | 83 Participants |
| Umbilical Cord Blood | Number of Participants With Neutrophil Engraftment | 2 Participants |
| Co-Enroll From MT0403 | Number of Participants With Neutrophil Engraftment | 2 Participants |
Secondary
Number of Participants With Persistence or Relapse of Malignancy at 2 Years Post Transplant
Defined as the return of disease after its apparent recovery/cessation. Patients with leukemia and lymphoma involving the BM and multiple myeloma will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients with lymphoma and myeloma will 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.
Time frame: 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PBSC: No TBI | Number of Participants With Persistence or Relapse of Malignancy at 2 Years Post Transplant | 3 Participants |
| Marrow : No TBI | Number of Participants With Persistence or Relapse of Malignancy at 2 Years Post Transplant | 4 Participants |
| UCB : No TBI | Number of Participants With Persistence or Relapse of Malignancy at 2 Years Post Transplant | 0 Participants |
| UCB : No TBI/Bu/Cy/ATG | Number of Participants With Persistence or Relapse of Malignancy at 2 Years Post Transplant | 0 Participants |
| PBSC | Number of Participants With Persistence or Relapse of Malignancy at 2 Years Post Transplant | 63 Participants |
| Marrow | Number of Participants With Persistence or Relapse of Malignancy at 2 Years Post Transplant | 17 Participants |
| Umbilical Cord Blood | Number of Participants With Persistence or Relapse of Malignancy at 2 Years Post Transplant | 0 Participants |
| Co-Enroll From MT0403 | Number of Participants With Persistence or Relapse of Malignancy at 2 Years Post Transplant | 0 Participants |
Secondary
Number of Participants With Persistence or Relapse of Malignancy at 5 Years Post Transplant
Defined as the return of disease after its apparent recovery/cessation. Patients with leukemia and lymphoma involving the BM and multiple myeloma will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients with lymphoma and myeloma will 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.
Time frame: 5 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PBSC: No TBI | Number of Participants With Persistence or Relapse of Malignancy at 5 Years Post Transplant | 4 Participants |
| Marrow : No TBI | Number of Participants With Persistence or Relapse of Malignancy at 5 Years Post Transplant | 4 Participants |
| UCB : No TBI | Number of Participants With Persistence or Relapse of Malignancy at 5 Years Post Transplant | 0 Participants |
| UCB : No TBI/Bu/Cy/ATG | Number of Participants With Persistence or Relapse of Malignancy at 5 Years Post Transplant | 0 Participants |
| PBSC | Number of Participants With Persistence or Relapse of Malignancy at 5 Years Post Transplant | 69 Participants |
| Marrow | Number of Participants With Persistence or Relapse of Malignancy at 5 Years Post Transplant | 20 Participants |
| Umbilical Cord Blood | Number of Participants With Persistence or Relapse of Malignancy at 5 Years Post Transplant | 0 Participants |
| Co-Enroll From MT0403 | Number of Participants With Persistence or Relapse of Malignancy at 5 Years Post Transplant | 0 Participants |