| ID | Type | Description | Link |
|---|---|---|---|
| MT2001-02 | Other Identifier | Blood and Marrow Transplantation Program | |
| 0107M05202 | Other Identifier | IRB, University of Minnesota |
Not provided
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replaced by another study ; Trial re-written as MT2015-29
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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.
Preparative regimen using total body irradiation (TBI) and cyclophosphamide:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PBSC: No TBI | Experimental | 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 |
|
| Marrow : No TBI | Experimental | Patients who are not able to receive Total Body Irradiation (TBI) receives cyclophosphamide, Busulfan and Bone Marrow as a source of stem cell transplant |
|
| UCB : No TBI | Experimental | 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 |
|
| UCB : No TBI/Bu/Cy/ATG | Experimental | 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 |
|
| PBSC |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stem Cell Transplant | Biological | 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.) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 years |
| 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. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 42 |
| Number of Participants With Acute Graft-versus-host Disease (GVHD) |
Not provided
Inclusion Criteria:
Exclusion Criteria
donors and recipients should meet the following test criteria.
required for donors:
required for recipients:
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Weisdorf, MD | Masonic Cancer Center, University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Masonic Cancer Center, University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
One patient withdrew consent.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 30, 2012 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Experimental |
Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplant |
|
| Marrow | Experimental | Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplant |
|
| UCB | Experimental | Patients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplant |
|
| Co-Enroll From MT0403 | Experimental | 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 | Drug | 60 mg/kg intravenously (IV) Days -6 and -5 or 50 mg/kg/day IV Days -5 through -2. |
|
|
| Total Body Irradiation | Radiation | On Day -4, -3, -2, -1 total body irradiation is given twice daily. |
|
|
| Busulfan | Drug | 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) | Drug | 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 |
|
| CD4+/CD25+ cells | Biological | On days -2, patients will receive CD4+/CD25+ cells intravenously. |
|
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. |
| Day 100 |
| 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. | 1 year |
| 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. | 2 years |
| 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. | 5 years |
| 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. | 2 years |
| 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. | 5 years |
| 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. | Day 42 |
| FG001 | 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 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. |
| FG002 | 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 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. |
| FG003 | 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 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 |
| FG004 | PBSC | 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. |
| FG005 | Marrow | 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. |
| FG006 | Umbilical Cord Blood | 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. |
| FG007 | 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) 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | 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 |
| BG003 | 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 |
| BG004 | PBSC | Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplant |
| BG005 | Marrow | Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplant |
| BG006 | Umbilical Cord Blood | Patients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplant |
| BG007 | 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) |
| BG008 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 2 years |
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Posted | Count of Participants | Participants | 5 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Posted | Count of Participants | Participants | Day 42 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Posted | Count of Participants | Participants | Day 100 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Posted | Count of Participants | Participants | 1 year |
| ||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Posted | Count of Participants | Participants | 2 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Posted | Count of Participants | Participants | 5 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Posted | Count of Participants | Participants | 2 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Posted | Count of Participants | Participants | 5 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Posted | Count of Participants | Participants | Day 42 |
|
5 years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 9 | 12 | 3 | 12 | 12 | 12 |
| EG001 | 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 | 4 | 13 | 0 | 13 | 10 | 13 |
| EG002 | 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 | 1 | 0 | 1 | 1 | 1 |
| EG003 | 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 | 1 | 0 | 1 | 1 | 1 |
| EG004 | PBSC | Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplant | 113 | 213 | 32 | 213 | 183 | 213 |
| EG005 | Marrow | Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplant | 31 | 85 | 10 | 85 | 71 | 85 |
| EG006 | Umbilical Cord Blood | Patients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplant | 0 | 2 | 0 | 2 | 2 | 2 |
| EG007 | 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) | 0 | 2 | 0 | 2 | 2 | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Graft versus host disease | Immune system disorders | Non-systematic Assessment |
| ||
| Primary Graft Failure | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Hemorrhage | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Death | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Relapse | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Syndromes | Immune system disorders | Non-systematic Assessment |
| ||
| Death | Infections and infestations | Non-systematic Assessment |
| ||
| Death due to accident | General disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Infections and infestations | Non-systematic Assessment |
| ||
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Intubation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Hypertension | Vascular disorders | Non-systematic Assessment |
| ||
| Cystitis | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Elevated Liver Function Tests | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| GI Bleeding | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Pericardial effusion | Cardiac disorders | Non-systematic Assessment |
| ||
| Dialysis | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Veno occlusive disease (VOD) | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pumonary hemorrhage | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Acute renal failure | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Neuropathy | Nervous system disorders | Non-systematic Assessment |
| ||
| Cardiac disorder | Cardiac disorders | Non-systematic Assessment |
| ||
| Neurotoxicity | Nervous system disorders | Non-systematic Assessment |
| ||
| Mucositis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Hyperglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Sinusitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Daniel J.Weisdorf, M.D | Masonic Cancer Center, University of Minnesota | 612 624-3101 | weisd001@umn.edu |
| Dec 18, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D006689 | Hodgkin Disease |
| D008228 | Lymphoma, Non-Hodgkin |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D015448 | Leukemia, B-Cell |
| D008223 | Lymphoma |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D033581 | Stem Cell Transplantation |
| D016026 | Bone Marrow Transplantation |
| D003520 | Cyclophosphamide |
| D014916 | Whole-Body Irradiation |
| D011878 | Radiotherapy |
| D002066 | Busulfan |
| D000961 | Antilymphocyte Serum |
| ID | Term |
|---|---|
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
| D016378 | Tissue Transplantation |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D008919 | Investigative Techniques |
| D002072 | Butylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D008698 | Mesylates |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D007106 | Immune Sera |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
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
| OG004 | PBSC | Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplant |
| OG005 | Marrow | Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplant |
| OG006 | Umbilical Cord Blood | Patients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplant |
| OG007 | 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) |
|
|
| OG004 | PBSC | Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplant |
| OG005 | Marrow | Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplant |
| OG006 | Umbilical Cord Blood | Patients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplant |
| OG007 | 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) |
|
|
| OG003 |
| 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 |
| OG004 | PBSC | Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplant |
| OG005 | Marrow | Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplant |
| OG006 | Umbilical Cord Blood | Patients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplant |
| OG007 | 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) |
|
|
| 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 |
| OG004 | PBSC | Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplant |
| OG005 | Marrow | Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplant |
| OG006 | Umbilical Cord Blood | Patients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplant |
| OG007 | 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) |
|
|
| OG003 | 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 |
| OG004 | PBSC | Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplant |
| OG005 | Marrow | Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplant |
| OG006 | Umbilical Cord Blood | Patients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplant |
| OG007 | 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) |
|
|
| OG003 | 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 |
| OG004 | PBSC | Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplant |
| OG005 | Marrow | Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplant |
| OG006 | Umbilical Cord Blood | Patients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplant |
| OG007 | 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) |
|
|
| OG004 | PBSC | Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplant |
| OG005 | Marrow | Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplant |
| OG006 | Umbilical Cord Blood | Patients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplant |
| OG007 | 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) |
|
|
| OG004 | PBSC | Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplant |
| OG005 | Marrow | Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplant |
| OG006 | Umbilical Cord Blood | Patients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplant |
| OG007 | 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) |
|
|
| OG004 | PBSC | Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplant |
| OG005 | Marrow | Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplant |
| OG006 | Umbilical Cord Blood | Patients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplant |
| OG007 | 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) |
|
|