Stem Cell Transplant for Hematological Malignancy

• Sponsor: Masonic Cancer Center, University of Minnesota (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00176930
• Collaborator: (none)
• Enrollment: 330
• Location: 1
• Arms: 8
• Actual Duration (Months): 218
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Leukemia, Myeloid, Chronic; AML; Leukemia, Lymphocytic, Acute; MDS; Leukemia, Lymphocytic, Chronic; JMML; Hodgkin's Disease; Non-hodgkin's Lymphoma; Multiple Myeloma	Biological: Stem Cell Transplant; Drug: Cyclophosphamide; Radiation: Total Body Irradiation; Drug: Busulfan; Drug: Equine ATG (ATGAM); Biological: CD4+/CD25+ cells	N/A

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.

1. 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.

1. On day -9, -8, -7, -6 busulfan is given.

2. On day -5, -4, -3, -2 cyclophosphamide is given.

3. On day -1 no therapy is given (day of rest).

4. 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 330 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Allogeneic Transplant for Hematological Malignancy
• Actual Study Start Date: Oct 1, 2001
• Actual Primary Completion Date: Dec 1, 2019
• Actual Study Completion Date: Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Biological: Stem 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.); Other Names: Bone Marrow Transplant. ; Drug: Cyclophosphamide; 60 mg/kg intravenously (IV) Days -6 and -5 or 50 mg/kg/day IV Days -5 through -2.; Other Names: Cytoxan ; Drug: Busulfan; When not receiving total body irradiation, administered Days -9 through -6, 0.8 mg/kg/dose by intravenous dosing every 6 hours.; Other Names: Busulfex Myleran
Experimental: 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	Biological: Stem 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.); Other Names: Bone Marrow Transplant. ; Drug: Cyclophosphamide; 60 mg/kg intravenously (IV) Days -6 and -5 or 50 mg/kg/day IV Days -5 through -2.; Other Names: Cytoxan ; Drug: Busulfan; When not receiving total body irradiation, administered Days -9 through -6, 0.8 mg/kg/dose by intravenous dosing every 6 hours.; Other Names: Busulfex Myleran
Experimental: 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	Biological: Stem 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.); Other Names: Bone Marrow Transplant. ; Drug: Cyclophosphamide; 60 mg/kg intravenously (IV) Days -6 and -5 or 50 mg/kg/day IV Days -5 through -2.; Other Names: Cytoxan ; Drug: Busulfan; When not receiving total body irradiation, administered Days -9 through -6, 0.8 mg/kg/dose by intravenous dosing every 6 hours.; Other Names: Busulfex Myleran
Experimental: 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	Biological: Stem 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.); Other Names: Bone Marrow Transplant. ; Drug: Cyclophosphamide; 60 mg/kg intravenously (IV) Days -6 and -5 or 50 mg/kg/day IV Days -5 through -2.; Other Names: Cytoxan ; Drug: Busulfan; When not receiving total body irradiation, administered Days -9 through -6, 0.8 mg/kg/dose by intravenous dosing every 6 hours.; Other Names: Busulfex Myleran ; Drug: Equine 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
Experimental: PBSC Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplant	Biological: Stem 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.); Other Names: Bone Marrow Transplant. ; Drug: Cyclophosphamide; 60 mg/kg intravenously (IV) Days -6 and -5 or 50 mg/kg/day IV Days -5 through -2.; Other Names: Cytoxan ; Radiation: Total Body Irradiation; On Day -4, -3, -2, -1 total body irradiation is given twice daily.; Other Names: Radiation therapy
Experimental: Marrow Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplant	Biological: Stem 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.); Other Names: Bone Marrow Transplant. ; Drug: Cyclophosphamide; 60 mg/kg intravenously (IV) Days -6 and -5 or 50 mg/kg/day IV Days -5 through -2.; Other Names: Cytoxan ; Radiation: Total Body Irradiation; On Day -4, -3, -2, -1 total body irradiation is given twice daily.; Other Names: Radiation therapy
Experimental: UCB Patients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplant	Biological: Stem 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.); Other Names: Bone Marrow Transplant. ; Drug: Cyclophosphamide; 60 mg/kg intravenously (IV) Days -6 and -5 or 50 mg/kg/day IV Days -5 through -2.; Other Names: Cytoxan ; Radiation: Total Body Irradiation; On Day -4, -3, -2, -1 total body irradiation is given twice daily.; Other Names: Radiation therapy
Experimental: 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)	Biological: Stem 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.); Other Names: Bone Marrow Transplant. ; Drug: Cyclophosphamide; 60 mg/kg intravenously (IV) Days -6 and -5 or 50 mg/kg/day IV Days -5 through -2.; Other Names: Cytoxan ; Radiation: Total Body Irradiation; On Day -4, -3, -2, -1 total body irradiation is given twice daily.; Other Names: Radiation therapy ; Biological: CD4+/CD25+ cells; On days -2, patients will receive CD4+/CD25+ cells intravenously.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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 Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 55 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Masonic Cancer Center, University of Minnesota	Minneapolis	Minnesota	United States	55455

Sponsors and Collaborators

• Masonic Cancer Center, University of Minnesota

Investigators

• Principal Investigator: Daniel Weisdorf, MD, Masonic Cancer Center, University of Minnesota

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 30, 2012

More Information

Publications

None provided.

• Responsible Party: Masonic Cancer Center, University of Minnesota
• ClinicalTrials.gov Identifier: NCT00176930
• Other Study ID Numbers: 2001LS049; MT2001-02; 0107M05202; NCT00393133
• First Posted: Sep 15, 2005
• Last Update Posted: Jan 22, 2021
• Last Verified: Dec 1, 2020

• Keywords provided by Masonic Cancer Center, University of Minnesota: stem cell transplant; chronic leukemia; acute leukemia; irradiation; chemotherapy
• Additional relevant MeSH terms: Leukemia; Multiple Myeloma; Hematologic Neoplasms; Hodgkin Disease; Leukemia, Myeloid; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Cyclophosphamide; Busulfan

Study Results

Participant Flow

Pre-assignment Detail	One patient withdrew consent.

Arm/Group Title	PBSC: No TBI	Marrow : No TBI	UCB : No TBI	UCB : No TBI/Bu/Cy/ATG	PBSC	Marrow	Umbilical Cord Blood	Co-Enroll From MT0403
Arm/Group Description	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 Cyclophosphamide: 60 mg/kg intravenously (IV) Days -6 and -5 or 50 mg/kg/day IV Days -5 through -2. Busulfan: When not receiving total body irradiation, administered Days -9 through -6, 0.8 mg/kg/dose by intravenous dosing every 6 hours.	Patients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Bone Marrow as a source of stem cell transplant Cyclophosphamide: 60 mg/kg intravenously (IV) Days -6 and -5 or 50 mg/kg/day IV Days -5 through -2. Busulfan: When not receiving total body irradiation, administered Days -9 through -6, 0.8 mg/kg/dose by intravenous dosing every 6 hours.	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 Cyclophosphamide: 60 mg/kg intravenously (IV) Days -6 and -5 or 50 mg/kg/day IV Days -5 through -2. Busulfan: When not receiving total body irradiation, administered Days -9 through -6, 0.8 mg/kg/dose by intravenous dosing every 6 hours.	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 Cyclophosphamide: 60 mg/kg intravenously (IV) Days -6 and -5 or 50 mg/kg/day IV Days -5 through -2. Busulfan: When not receiving total body irradiation, administered Days -9 through -6, 0.8 mg/kg/dose by intravenous dosing every 6 hours. Equine 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	Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplant Cyclophosphamide: 60 mg/kg intravenously (IV) Days -6 and -5 or 50 mg/kg/day IV Days -5 through -2. Total Body Irradiation: On Day -4, -3, -2, -1 total body irradiation is given twice daily.	Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplant Cyclophosphamide: 60 mg/kg intravenously (IV) Days -6 and -5 or 50 mg/kg/day IV Days -5 through -2. Total Body Irradiation: On Day -4, -3, -2, -1 total body irradiation is given twice daily.	Patients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplant Cyclophosphamide: 60 mg/kg intravenously (IV) Days -6 and -5 or 50 mg/kg/day IV Days -5 through -2. Total Body Irradiation: On Day -4, -3, -2, -1 total body irradiation is given twice daily.	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) Cyclophosphamide: 60 mg/kg intravenously (IV) Days -6 and -5 or 50 mg/kg/day IV Days -5 through -2. Total Body Irradiation: On Day -4, -3, -2, -1 total body irradiation is given twice daily. CD4+/CD25+ cells: On days -2, patients will receive CD4+/CD25+ cells intravenously.
Period Title: Overall Study
STARTED	12	13	1	1	213	85	2	2
COMPLETED	12	13	1	1	213	85	2	2
NOT COMPLETED	0	0	0	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	PBSC: No TBI	Marrow : No TBI	UCB : No TBI	UCB : No TBI/Bu/Cy/ATG	PBSC	Marrow	Umbilical Cord Blood	Co-Enroll From MT0403	Total
Arm/Group Description	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	Patients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Bone Marrow as a source of stem cell transplant	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	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	Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplant	Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplant	Patients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplant	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)	Total of all reporting groups
Overall Participants	12	13	1	1	213	85	2	2	329
Age (Count of Participants)
<=18 years	0 0%	12 92.3%	0 0%	0 0%	9 4.2%	51 60%	2 100%	2 100%	76 23.1%
Between 18 and 65 years	12 100%	1 7.7%	1 100%	1 100%	204 95.8%	34 40%	0 0%	0 0%	253 76.9%
>=65 years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	10 83.3%	4 30.8%	0 0%	1 100%	78 36.6%	35 41.2%	1 50%	1 50%	130 39.5%
Male	2 16.7%	9 69.2%	1 100%	0 0%	135 63.4%	50 58.8%	1 50%	1 50%	199 60.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%	0 0%	1 0.5%	4 4.7%	0 0%	0 0%	5 1.5%
Not Hispanic or Latino	5 41.7%	11 84.6%	1 100%	1 100%	82 38.5%	41 48.2%	2 100%	2 100%	145 44.1%
Unknown or Not Reported	7 58.3%	2 15.4%	0 0%	0 0%	130 61%	40 47.1%	0 0%	0 0%	179 54.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	4 1.9%	3 3.5%	0 0%	0 0%	7 2.1%
Asian	0 0%	0 0%	0 0%	0 0%	6 2.8%	4 4.7%	0 0%	0 0%	10 3%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%	1 1.2%	0 0%	0 0%	1 0.3%
Black or African American	0 0%	0 0%	0 0%	0 0%	5 2.3%	3 3.5%	0 0%	0 0%	8 2.4%
White	11 91.7%	13 100%	1 100%	1 100%	178 83.6%	64 75.3%	2 100%	2 100%	272 82.7%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	1 8.3%	0 0%	0 0%	0 0%	20 9.4%	10 11.8%	0 0%	0 0%	31 9.4%
Region of Enrollment (participants) [Number]
United States	12 100%	13 100%	1 100%	1 100%	213 100%	85 100%	2 100%	2 100%	329 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Experiencing Disease-Free Survival at 2 Years Post Transplant
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PBSC: No TBI	Marrow : No TBI	UCB : No TBI	UCB : No TBI/Bu/Cy/ATG	PBSC	Marrow	Umbilical Cord Blood	Co-Enroll From MT0403
Arm/Group Description	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	Patients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Bone Marrow as a source of stem cell transplant	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	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	Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplant	Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplant	Patients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplant	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)
Measure Participants	12	13	1	1	213	85	2	2
Count of Participants [Participants]	4 33.3%	9 69.2%	0 0%	0 0%	100 46.9%	52 61.2%	2 100%	2 100%

2. Primary Outcome

Title	Number of Participants Experiencing Disease-Free Survival at 5 Years Post Transplant
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PBSC: No TBI	Marrow : No TBI	UCB : No TBI	UCB : No TBI/Bu/Cy/ATG	PBSC	Marrow	Umbilical Cord Blood	Co-Enroll From MT0403
Arm/Group Description	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	Patients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Bone Marrow as a source of stem cell transplant	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	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	Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplant	Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplant	Patients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplant	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)
Measure Participants	12	13	1	1	213	85	2	2
Count of Participants [Participants]	3 25%	9 69.2%	0 0%	0 0%	85 39.9%	48 56.5%	2 100%	2 100%

3. Secondary Outcome

Title	Number of Participants With Neutrophil Engraftment
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PBSC: No TBI	Marrow : No TBI	UCB : No TBI	UCB : No TBI/Bu/Cy/ATG	PBSC	Marrow	Umbilical Cord Blood	Co-Enroll From MT0403
Arm/Group Description	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	Patients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Bone Marrow as a source of stem cell transplant	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	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	Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplant	Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplant	Patients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplant	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)
Measure Participants	12	13	1	1	213	85	2	2
Count of Participants [Participants]	11 91.7%	13 100%	0 0%	1 100%	206 96.7%	83 97.6%	2 100%	2 100%

4. Secondary Outcome

Title	Number of Participants With Acute Graft-versus-host Disease (GVHD)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PBSC: No TBI	Marrow : No TBI	UCB : No TBI	UCB : No TBI/Bu/Cy/ATG	PBSC	Marrow	Umbilical Cord Blood	Co-Enroll From MT0403
Arm/Group Description	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	Patients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Bone Marrow as a source of stem cell transplant	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	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	Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplant	Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplant	Patients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplant	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)
Measure Participants	12	13	1	1	213	85	2	2
Count of Participants [Participants]	6 50%	2 15.4%	1 100%	0 0%	89 41.8%	23 27.1%	0 0%	0 0%

5. Secondary Outcome

Title	Number of Participants With Chronic Graft-Versus-Host Disease
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PBSC: No TBI	Marrow : No TBI	UCB : No TBI	UCB : No TBI/Bu/Cy/ATG	PBSC	Marrow	Umbilical Cord Blood	Co-Enroll From MT0403
Arm/Group Description	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	Patients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Bone Marrow as a source of stem cell transplant	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	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	Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplant	Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplant	Patients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplant	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)
Measure Participants	12	13	1	1	213	85	2	2
Count of Participants [Participants]	4 33.3%	2 15.4%	0 0%	0 0%	87 40.8%	14 16.5%	0 0%	1 50%

6. Secondary Outcome

Title	Number of Participants With Persistence or Relapse of Malignancy at 2 Years Post Transplant
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PBSC: No TBI	Marrow : No TBI	UCB : No TBI	UCB : No TBI/Bu/Cy/ATG	PBSC	Marrow	Umbilical Cord Blood	Co-Enroll From MT0403
Arm/Group Description	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	Patients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Bone Marrow as a source of stem cell transplant	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	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	Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplant	Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplant	Patients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplant	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)
Measure Participants	12	13	1	1	213	85	2	2
Count of Participants [Participants]	3 25%	4 30.8%	0 0%	0 0%	63 29.6%	17 20%	0 0%	0 0%

7. Secondary Outcome

Title	Number of Participants With Persistence or Relapse of Malignancy at 5 Years Post Transplant
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PBSC: No TBI	Marrow : No TBI	UCB : No TBI	UCB : No TBI/Bu/Cy/ATG	PBSC	Marrow	Umbilical Cord Blood	Co-Enroll From MT0403
Arm/Group Description	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	Patients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Bone Marrow as a source of stem cell transplant	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	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	Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplant	Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplant	Patients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplant	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)
Measure Participants	12	13	1	1	213	85	2	2
Count of Participants [Participants]	4 33.3%	4 30.8%	0 0%	0 0%	69 32.4%	20 23.5%	0 0%	0 0%

8. Secondary Outcome

Title	Number of Participants Who Were Alive at 2 Year Post Transplant
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PBSC: No TBI	Marrow : No TBI	UCB : No TBI	UCB : No TBI/Bu/Cy/ATG	PBSC	Marrow	Umbilical Cord Blood	Co-Enroll From MT0403
Arm/Group Description	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	Patients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Bone Marrow as a source of stem cell transplant	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	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	Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplant	Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplant	Patients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplant	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)
Measure Participants	12	13	1	1	213	85	2	2
Count of Participants [Participants]	5 41.7%	11 84.6%	0 0%	0 0%	122 57.3%	59 69.4%	2 100%	2 100%

9. Secondary Outcome

Title	Number of Participants Who Were Alive at 5 Year Post Transplant
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PBSC: No TBI	Marrow : No TBI	UCB : No TBI	UCB : No TBI/Bu/Cy/ATG	PBSC	Marrow	Umbilical Cord Blood	Co-Enroll From MT0403
Arm/Group Description	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	Patients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Bone Marrow as a source of stem cell transplant	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	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	Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplant	Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplant	Patients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplant	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)
Measure Participants	12	13	1	1	213	85	2	2
Count of Participants [Participants]	3 25%	9 69.2%	0 0%	0 0%	100 46.9%	54 63.5%	2 100%	2 100%

10. Secondary Outcome

Title	Number of Participants Experiencing Engraftment Failure
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PBSC: No TBI	Marrow : No TBI	UCB : No TBI	UCB : No TBI/Bu/Cy/ATG	PBSC	Marrow	Umbilical Cord Blood	Co-Enroll From MT0403
Arm/Group Description	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	Patients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Bone Marrow as a source of stem cell transplant	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	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	Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplant	Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplant	Patients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplant	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)
Measure Participants	12	13	1	1	213	85	2	2
Count of Participants [Participants]	0 0%	0 0%	0 0%	0 0%	1 0.5%	0 0%	0 0%	0 0%

Adverse Events

Time Frame	5 years
Arm/Group Title	PBSC: No TBI		Marrow : No TBI		UCB : No TBI		UCB : No TBI/Bu/Cy/ATG		PBSC		Marrow		Umbilical Cord Blood		Co-Enroll From MT0403
Arm/Group Description	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		Patients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Bone Marrow as a source of stem cell transplant		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		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		Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplant		Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplant		Patients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplant		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)
All Cause Mortality
	PBSC: No TBI		Marrow : No TBI		UCB : No TBI		UCB : No TBI/Bu/Cy/ATG		PBSC		Marrow		Umbilical Cord Blood		Co-Enroll From MT0403
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/12 (75%)		4/13 (30.8%)		1/1 (100%)		1/1 (100%)		113/213 (53.1%)		31/85 (36.5%)		0/2 (0%)		0/2 (0%)
Serious Adverse Events
	PBSC: No TBI		Marrow : No TBI		UCB : No TBI		UCB : No TBI/Bu/Cy/ATG		PBSC		Marrow		Umbilical Cord Blood		Co-Enroll From MT0403
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/12 (25%)		0/13 (0%)		0/1 (0%)		0/1 (0%)		32/213 (15%)		10/85 (11.8%)		0/2 (0%)		0/2 (0%)
Blood and lymphatic system disorders
Hemorrhage	0/12 (0%)	0	0/13 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/213 (0.5%)	1	0/85 (0%)	0	0/2 (0%)	0	0/2 (0%)	0
General disorders
Death due to accident	0/12 (0%)	0	0/13 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/213 (0.5%)	1	0/85 (0%)	0	0/2 (0%)	0	0/2 (0%)	0
Immune system disorders
Graft versus host disease	1/12 (8.3%)	1	0/13 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	2/213 (0.9%)	2	0/85 (0%)	0	0/2 (0%)	0	0/2 (0%)	0
Syndromes	0/12 (0%)	0	0/13 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	1/213 (0.5%)	1	0/85 (0%)	0	0/2 (0%)	0	0/2 (0%)	0
Infections and infestations
Death	0/12 (0%)	0	0/13 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	4/213 (1.9%)	4	0/85 (0%)	0	0/2 (0%)	0	0/2 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Primary Graft Failure	1/12 (8.3%)	1	0/13 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	0/213 (0%)	0	1/85 (1.2%)	1	0/2 (0%)	0	0/2 (0%)	0
Death	1/12 (8.3%)	1	0/13 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	20/213 (9.4%)	20	8/85 (9.4%)	8	0/2 (0%)	0	0/2 (0%)	0
Relapse	1/12 (8.3%)	1	0/13 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	8/213 (3.8%)	8	3/85 (3.5%)	3	0/2 (0%)	0	0/2 (0%)	0
Other (Not Including Serious) Adverse Events
	PBSC: No TBI		Marrow : No TBI		UCB : No TBI		UCB : No TBI/Bu/Cy/ATG		PBSC		Marrow		Umbilical Cord Blood		Co-Enroll From MT0403
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/12 (100%)		10/13 (76.9%)		1/1 (100%)		1/1 (100%)		183/213 (85.9%)		71/85 (83.5%)		2/2 (100%)		2/2 (100%)
Cardiac disorders
Pericardial effusion	1/12 (8.3%)	1	5/13 (38.5%)	5	0/1 (0%)	0	1/1 (100%)	1	12/213 (5.6%)	12	13/85 (15.3%)	13	0/2 (0%)	0	1/2 (50%)	2
Cardiac disorder	1/12 (8.3%)	1	1/13 (7.7%)	1	1/1 (100%)	1	0/1 (0%)	0	8/213 (3.8%)	8	6/85 (7.1%)	7	0/2 (0%)	0	1/2 (50%)	1
Gastrointestinal disorders
GI Bleeding	3/12 (25%)	4	0/13 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	24/213 (11.3%)	26	6/85 (7.1%)	7	0/2 (0%)	0	0/2 (0%)	0
Mucositis	2/12 (16.7%)	2	0/13 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	13/213 (6.1%)	13	2/85 (2.4%)	2	0/2 (0%)	0	0/2 (0%)	0
Hepatobiliary disorders
Elevated Liver Function Tests	2/12 (16.7%)	2	1/13 (7.7%)	1	0/1 (0%)	0	0/1 (0%)	0	25/213 (11.7%)	26	10/85 (11.8%)	11	0/2 (0%)	0	0/2 (0%)	0
Infections and infestations
Infection	10/12 (83.3%)	37	9/13 (69.2%)	32	1/1 (100%)	6	1/1 (100%)	4	114/213 (53.5%)	375	54/85 (63.5%)	169	1/2 (50%)	2	0/2 (0%)	0
Metabolism and nutrition disorders
Hyperglycemia	0/12 (0%)	0	0/13 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	12/213 (5.6%)	12	4/85 (4.7%)	4	0/2 (0%)	0	0/2 (0%)	0
Nervous system disorders
Neuropathy	2/12 (16.7%)	2	1/13 (7.7%)	1	0/1 (0%)	0	0/1 (0%)	0	14/213 (6.6%)	15	5/85 (5.9%)	5	0/2 (0%)	0	1/2 (50%)	1
Neurotoxicity	2/12 (16.7%)	4	0/13 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	11/213 (5.2%)	11	3/85 (3.5%)	3	0/2 (0%)	0	0/2 (0%)	0
Renal and urinary disorders
Cystitis	6/12 (50%)	6	2/13 (15.4%)	2	1/1 (100%)	1	0/1 (0%)	0	25/213 (11.7%)	25	11/85 (12.9%)	11	0/2 (0%)	0	0/2 (0%)	0
Dialysis	2/12 (16.7%)	2	0/13 (0%)	0	1/1 (100%)	1	0/1 (0%)	0	16/213 (7.5%)	16	8/85 (9.4%)	12	0/2 (0%)	0	0/2 (0%)	0
Acute renal failure	1/12 (8.3%)	1	0/13 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	16/213 (7.5%)	16	7/85 (8.2%)	8	0/2 (0%)	0	0/2 (0%)	0
Respiratory, thoracic and mediastinal disorders
Pneumonia	5/12 (41.7%)	14	6/13 (46.2%)	8	1/1 (100%)	14	1/1 (100%)	1	91/213 (42.7%)	143	42/85 (49.4%)	70	1/2 (50%)	1	2/2 (100%)	7
Intubation	3/12 (25%)	4	2/13 (15.4%)	2	0/1 (0%)	0	0/1 (0%)	0	34/213 (16%)	45	14/85 (16.5%)	22	0/2 (0%)	0	1/2 (50%)	2
Veno occlusive disease (VOD)	2/12 (16.7%)	3	1/13 (7.7%)	1	0/1 (0%)	0	0/1 (0%)	0	15/213 (7%)	18	7/85 (8.2%)	10	0/2 (0%)	0	0/2 (0%)	0
Pumonary hemorrhage	1/12 (8.3%)	1	0/13 (0%)	0	1/1 (100%)	1	0/1 (0%)	0	16/213 (7.5%)	18	7/85 (8.2%)	7	0/2 (0%)	0	0/2 (0%)	0
Sinusitis	0/12 (0%)	0	0/13 (0%)	0	0/1 (0%)	0	0/1 (0%)	0	10/213 (4.7%)	10	6/85 (7.1%)	6	0/2 (0%)	0	0/2 (0%)	0
Vascular disorders
Hypertension	2/12 (16.7%)	2	6/13 (46.2%)	6	0/1 (0%)	0	0/1 (0%)	0	26/213 (12.2%)	27	21/85 (24.7%)	23	1/2 (50%)	1	0/2 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.