Trial Outcomes & Findings for Stem Cell Transplant for Hematological Malignancy (NCT NCT00176930)
NCT ID: NCT00176930
Last Updated: 2021-01-22
Results Overview
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.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
330 participants
Primary outcome timeframe
2 years
Results posted on
2021-01-22
Participant Flow
One patient withdrew consent.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
13
|
1
|
1
|
213
|
85
|
2
|
2
|
|
Overall Study
COMPLETED
|
12
|
13
|
1
|
1
|
213
|
85
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Stem Cell Transplant for Hematological Malignancy
Baseline characteristics by cohort
| Measure |
PBSC: No TBI
n=12 Participants
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
n=13 Participants
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
n=1 Participants
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
n=1 Participants
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
n=213 Participants
Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplant
|
Marrow
n=85 Participants
Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplant
|
Umbilical Cord Blood
n=2 Participants
Patients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplant
|
Co-Enroll From MT0403
n=2 Participants
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
n=329 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
51 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
76 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
204 Participants
n=21 Participants
|
34 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
253 Participants
n=6 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
78 Participants
n=21 Participants
|
35 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
130 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
135 Participants
n=21 Participants
|
50 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
199 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
82 Participants
n=21 Participants
|
41 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
145 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
130 Participants
n=21 Participants
|
40 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
179 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
7 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
10 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
8 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
178 Participants
n=21 Participants
|
64 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
272 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
31 Participants
n=6 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
13 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
213 participants
n=21 Participants
|
85 participants
n=10 Participants
|
2 participants
n=115 Participants
|
2 participants
n=6 Participants
|
329 participants
n=6 Participants
|
PRIMARY outcome
Timeframe: 2 yearsDisease-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.
Outcome measures
| Measure |
PBSC: No TBI
n=12 Participants
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
n=13 Participants
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
n=1 Participants
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
n=1 Participants
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
n=213 Participants
Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplant
|
Marrow
n=85 Participants
Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplant
|
Umbilical Cord Blood
n=2 Participants
Patients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplant
|
Co-Enroll From MT0403
n=2 Participants
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)
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Experiencing Disease-Free Survival at 2 Years Post Transplant
|
4 Participants
|
9 Participants
|
0 Participants
|
0 Participants
|
100 Participants
|
52 Participants
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 5 yearsDisease-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.
Outcome measures
| Measure |
PBSC: No TBI
n=12 Participants
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
n=13 Participants
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
n=1 Participants
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
n=1 Participants
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
n=213 Participants
Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplant
|
Marrow
n=85 Participants
Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplant
|
Umbilical Cord Blood
n=2 Participants
Patients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplant
|
Co-Enroll From MT0403
n=2 Participants
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)
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Experiencing Disease-Free Survival at 5 Years Post Transplant
|
3 Participants
|
9 Participants
|
0 Participants
|
0 Participants
|
85 Participants
|
48 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 42Neutrophil 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.
Outcome measures
| Measure |
PBSC: No TBI
n=12 Participants
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
n=13 Participants
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
n=1 Participants
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
n=1 Participants
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
n=213 Participants
Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplant
|
Marrow
n=85 Participants
Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplant
|
Umbilical Cord Blood
n=2 Participants
Patients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplant
|
Co-Enroll From MT0403
n=2 Participants
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)
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Neutrophil Engraftment
|
11 Participants
|
13 Participants
|
0 Participants
|
1 Participants
|
206 Participants
|
83 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 100Acute 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.
Outcome measures
| Measure |
PBSC: No TBI
n=12 Participants
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
n=13 Participants
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
n=1 Participants
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
n=1 Participants
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
n=213 Participants
Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplant
|
Marrow
n=85 Participants
Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplant
|
Umbilical Cord Blood
n=2 Participants
Patients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplant
|
Co-Enroll From MT0403
n=2 Participants
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)
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Acute Graft-versus-host Disease (GVHD)
|
6 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
89 Participants
|
23 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 yearChronic 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.
Outcome measures
| Measure |
PBSC: No TBI
n=12 Participants
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
n=13 Participants
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
n=1 Participants
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
n=1 Participants
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
n=213 Participants
Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplant
|
Marrow
n=85 Participants
Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplant
|
Umbilical Cord Blood
n=2 Participants
Patients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplant
|
Co-Enroll From MT0403
n=2 Participants
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)
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Chronic Graft-Versus-Host Disease
|
4 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
87 Participants
|
14 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 2 yearsDefined 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.
Outcome measures
| Measure |
PBSC: No TBI
n=12 Participants
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
n=13 Participants
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
n=1 Participants
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
n=1 Participants
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
n=213 Participants
Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplant
|
Marrow
n=85 Participants
Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplant
|
Umbilical Cord Blood
n=2 Participants
Patients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplant
|
Co-Enroll From MT0403
n=2 Participants
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)
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Persistence or Relapse of Malignancy at 2 Years Post Transplant
|
3 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
63 Participants
|
17 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 5 yearsDefined 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.
Outcome measures
| Measure |
PBSC: No TBI
n=12 Participants
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
n=13 Participants
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
n=1 Participants
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
n=1 Participants
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
n=213 Participants
Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplant
|
Marrow
n=85 Participants
Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplant
|
Umbilical Cord Blood
n=2 Participants
Patients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplant
|
Co-Enroll From MT0403
n=2 Participants
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)
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Persistence or Relapse of Malignancy at 5 Years Post Transplant
|
4 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
69 Participants
|
20 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 yearsThe 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.
Outcome measures
| Measure |
PBSC: No TBI
n=12 Participants
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
n=13 Participants
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
n=1 Participants
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
n=1 Participants
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
n=213 Participants
Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplant
|
Marrow
n=85 Participants
Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplant
|
Umbilical Cord Blood
n=2 Participants
Patients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplant
|
Co-Enroll From MT0403
n=2 Participants
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)
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Were Alive at 2 Year Post Transplant
|
5 Participants
|
11 Participants
|
0 Participants
|
0 Participants
|
122 Participants
|
59 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 5 yearsThe 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.
Outcome measures
| Measure |
PBSC: No TBI
n=12 Participants
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
n=13 Participants
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
n=1 Participants
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
n=1 Participants
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
n=213 Participants
Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplant
|
Marrow
n=85 Participants
Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplant
|
Umbilical Cord Blood
n=2 Participants
Patients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplant
|
Co-Enroll From MT0403
n=2 Participants
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)
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Were Alive at 5 Year Post Transplant
|
3 Participants
|
9 Participants
|
0 Participants
|
0 Participants
|
100 Participants
|
54 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 42Graft failure is defined as not accepting donated cells. The donated cells do not make the new white blood cells, red blood cells and platelets.
Outcome measures
| Measure |
PBSC: No TBI
n=12 Participants
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
n=13 Participants
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
n=1 Participants
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
n=1 Participants
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
n=213 Participants
Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplant
|
Marrow
n=85 Participants
Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplant
|
Umbilical Cord Blood
n=2 Participants
Patients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplant
|
Co-Enroll From MT0403
n=2 Participants
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)
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Experiencing Engraftment Failure
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
PBSC: No TBI
Serious events: 3 serious events
Other events: 12 other events
Deaths: 9 deaths
Marrow : No TBI
Serious events: 0 serious events
Other events: 10 other events
Deaths: 4 deaths
UCB : No TBI
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
UCB : No TBI/Bu/Cy/ATG
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
PBSC
Serious events: 32 serious events
Other events: 183 other events
Deaths: 113 deaths
Marrow
Serious events: 10 serious events
Other events: 71 other events
Deaths: 31 deaths
Umbilical Cord Blood
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Co-Enroll From MT0403
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PBSC: No TBI
n=12 participants at risk
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
n=13 participants at risk
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
n=1 participants at risk
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
n=1 participants at risk
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
n=213 participants at risk
Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplant
|
Marrow
n=85 participants at risk
Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplant
|
Umbilical Cord Blood
n=2 participants at risk
Patients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplant
|
Co-Enroll From MT0403
n=2 participants at risk
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)
|
|---|---|---|---|---|---|---|---|---|
|
Immune system disorders
Graft versus host disease
|
8.3%
1/12 • Number of events 1 • 5 years
|
0.00%
0/13 • 5 years
|
0.00%
0/1 • 5 years
|
0.00%
0/1 • 5 years
|
0.94%
2/213 • Number of events 2 • 5 years
|
0.00%
0/85 • 5 years
|
0.00%
0/2 • 5 years
|
0.00%
0/2 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Primary Graft Failure
|
8.3%
1/12 • Number of events 1 • 5 years
|
0.00%
0/13 • 5 years
|
0.00%
0/1 • 5 years
|
0.00%
0/1 • 5 years
|
0.00%
0/213 • 5 years
|
1.2%
1/85 • Number of events 1 • 5 years
|
0.00%
0/2 • 5 years
|
0.00%
0/2 • 5 years
|
|
Blood and lymphatic system disorders
Hemorrhage
|
0.00%
0/12 • 5 years
|
0.00%
0/13 • 5 years
|
0.00%
0/1 • 5 years
|
0.00%
0/1 • 5 years
|
0.47%
1/213 • Number of events 1 • 5 years
|
0.00%
0/85 • 5 years
|
0.00%
0/2 • 5 years
|
0.00%
0/2 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death
|
8.3%
1/12 • Number of events 1 • 5 years
|
0.00%
0/13 • 5 years
|
0.00%
0/1 • 5 years
|
0.00%
0/1 • 5 years
|
9.4%
20/213 • Number of events 20 • 5 years
|
9.4%
8/85 • Number of events 8 • 5 years
|
0.00%
0/2 • 5 years
|
0.00%
0/2 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Relapse
|
8.3%
1/12 • Number of events 1 • 5 years
|
0.00%
0/13 • 5 years
|
0.00%
0/1 • 5 years
|
0.00%
0/1 • 5 years
|
3.8%
8/213 • Number of events 8 • 5 years
|
3.5%
3/85 • Number of events 3 • 5 years
|
0.00%
0/2 • 5 years
|
0.00%
0/2 • 5 years
|
|
Immune system disorders
Syndromes
|
0.00%
0/12 • 5 years
|
0.00%
0/13 • 5 years
|
0.00%
0/1 • 5 years
|
0.00%
0/1 • 5 years
|
0.47%
1/213 • Number of events 1 • 5 years
|
0.00%
0/85 • 5 years
|
0.00%
0/2 • 5 years
|
0.00%
0/2 • 5 years
|
|
Infections and infestations
Death
|
0.00%
0/12 • 5 years
|
0.00%
0/13 • 5 years
|
0.00%
0/1 • 5 years
|
0.00%
0/1 • 5 years
|
1.9%
4/213 • Number of events 4 • 5 years
|
0.00%
0/85 • 5 years
|
0.00%
0/2 • 5 years
|
0.00%
0/2 • 5 years
|
|
General disorders
Death due to accident
|
0.00%
0/12 • 5 years
|
0.00%
0/13 • 5 years
|
0.00%
0/1 • 5 years
|
0.00%
0/1 • 5 years
|
0.47%
1/213 • Number of events 1 • 5 years
|
0.00%
0/85 • 5 years
|
0.00%
0/2 • 5 years
|
0.00%
0/2 • 5 years
|
Other adverse events
| Measure |
PBSC: No TBI
n=12 participants at risk
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
n=13 participants at risk
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
n=1 participants at risk
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
n=1 participants at risk
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
n=213 participants at risk
Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Peripheral blood stem cells as a source of transplant
|
Marrow
n=85 participants at risk
Patients receiving cyclophosphamide, Total Body Irradiation (TBI) and Bone Marrow as a source of stem cell transplant
|
Umbilical Cord Blood
n=2 participants at risk
Patients receiving cyclophosphamide, Total Body Irradiation (TBI), and Umbilical Cord Blood (UCB) as a source of stem cell transplant
|
Co-Enroll From MT0403
n=2 participants at risk
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)
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Infection
|
83.3%
10/12 • Number of events 37 • 5 years
|
69.2%
9/13 • Number of events 32 • 5 years
|
100.0%
1/1 • Number of events 6 • 5 years
|
100.0%
1/1 • Number of events 4 • 5 years
|
53.5%
114/213 • Number of events 375 • 5 years
|
63.5%
54/85 • Number of events 169 • 5 years
|
50.0%
1/2 • Number of events 2 • 5 years
|
0.00%
0/2 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
41.7%
5/12 • Number of events 14 • 5 years
|
46.2%
6/13 • Number of events 8 • 5 years
|
100.0%
1/1 • Number of events 14 • 5 years
|
100.0%
1/1 • Number of events 1 • 5 years
|
42.7%
91/213 • Number of events 143 • 5 years
|
49.4%
42/85 • Number of events 70 • 5 years
|
50.0%
1/2 • Number of events 1 • 5 years
|
100.0%
2/2 • Number of events 7 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Intubation
|
25.0%
3/12 • Number of events 4 • 5 years
|
15.4%
2/13 • Number of events 2 • 5 years
|
0.00%
0/1 • 5 years
|
0.00%
0/1 • 5 years
|
16.0%
34/213 • Number of events 45 • 5 years
|
16.5%
14/85 • Number of events 22 • 5 years
|
0.00%
0/2 • 5 years
|
50.0%
1/2 • Number of events 2 • 5 years
|
|
Vascular disorders
Hypertension
|
16.7%
2/12 • Number of events 2 • 5 years
|
46.2%
6/13 • Number of events 6 • 5 years
|
0.00%
0/1 • 5 years
|
0.00%
0/1 • 5 years
|
12.2%
26/213 • Number of events 27 • 5 years
|
24.7%
21/85 • Number of events 23 • 5 years
|
50.0%
1/2 • Number of events 1 • 5 years
|
0.00%
0/2 • 5 years
|
|
Renal and urinary disorders
Cystitis
|
50.0%
6/12 • Number of events 6 • 5 years
|
15.4%
2/13 • Number of events 2 • 5 years
|
100.0%
1/1 • Number of events 1 • 5 years
|
0.00%
0/1 • 5 years
|
11.7%
25/213 • Number of events 25 • 5 years
|
12.9%
11/85 • Number of events 11 • 5 years
|
0.00%
0/2 • 5 years
|
0.00%
0/2 • 5 years
|
|
Hepatobiliary disorders
Elevated Liver Function Tests
|
16.7%
2/12 • Number of events 2 • 5 years
|
7.7%
1/13 • Number of events 1 • 5 years
|
0.00%
0/1 • 5 years
|
0.00%
0/1 • 5 years
|
11.7%
25/213 • Number of events 26 • 5 years
|
11.8%
10/85 • Number of events 11 • 5 years
|
0.00%
0/2 • 5 years
|
0.00%
0/2 • 5 years
|
|
Gastrointestinal disorders
GI Bleeding
|
25.0%
3/12 • Number of events 4 • 5 years
|
0.00%
0/13 • 5 years
|
0.00%
0/1 • 5 years
|
0.00%
0/1 • 5 years
|
11.3%
24/213 • Number of events 26 • 5 years
|
7.1%
6/85 • Number of events 7 • 5 years
|
0.00%
0/2 • 5 years
|
0.00%
0/2 • 5 years
|
|
Cardiac disorders
Pericardial effusion
|
8.3%
1/12 • Number of events 1 • 5 years
|
38.5%
5/13 • Number of events 5 • 5 years
|
0.00%
0/1 • 5 years
|
100.0%
1/1 • Number of events 1 • 5 years
|
5.6%
12/213 • Number of events 12 • 5 years
|
15.3%
13/85 • Number of events 13 • 5 years
|
0.00%
0/2 • 5 years
|
50.0%
1/2 • Number of events 2 • 5 years
|
|
Renal and urinary disorders
Dialysis
|
16.7%
2/12 • Number of events 2 • 5 years
|
0.00%
0/13 • 5 years
|
100.0%
1/1 • Number of events 1 • 5 years
|
0.00%
0/1 • 5 years
|
7.5%
16/213 • Number of events 16 • 5 years
|
9.4%
8/85 • Number of events 12 • 5 years
|
0.00%
0/2 • 5 years
|
0.00%
0/2 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Veno occlusive disease (VOD)
|
16.7%
2/12 • Number of events 3 • 5 years
|
7.7%
1/13 • Number of events 1 • 5 years
|
0.00%
0/1 • 5 years
|
0.00%
0/1 • 5 years
|
7.0%
15/213 • Number of events 18 • 5 years
|
8.2%
7/85 • Number of events 10 • 5 years
|
0.00%
0/2 • 5 years
|
0.00%
0/2 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pumonary hemorrhage
|
8.3%
1/12 • Number of events 1 • 5 years
|
0.00%
0/13 • 5 years
|
100.0%
1/1 • Number of events 1 • 5 years
|
0.00%
0/1 • 5 years
|
7.5%
16/213 • Number of events 18 • 5 years
|
8.2%
7/85 • Number of events 7 • 5 years
|
0.00%
0/2 • 5 years
|
0.00%
0/2 • 5 years
|
|
Renal and urinary disorders
Acute renal failure
|
8.3%
1/12 • Number of events 1 • 5 years
|
0.00%
0/13 • 5 years
|
0.00%
0/1 • 5 years
|
0.00%
0/1 • 5 years
|
7.5%
16/213 • Number of events 16 • 5 years
|
8.2%
7/85 • Number of events 8 • 5 years
|
0.00%
0/2 • 5 years
|
0.00%
0/2 • 5 years
|
|
Nervous system disorders
Neuropathy
|
16.7%
2/12 • Number of events 2 • 5 years
|
7.7%
1/13 • Number of events 1 • 5 years
|
0.00%
0/1 • 5 years
|
0.00%
0/1 • 5 years
|
6.6%
14/213 • Number of events 15 • 5 years
|
5.9%
5/85 • Number of events 5 • 5 years
|
0.00%
0/2 • 5 years
|
50.0%
1/2 • Number of events 1 • 5 years
|
|
Cardiac disorders
Cardiac disorder
|
8.3%
1/12 • Number of events 1 • 5 years
|
7.7%
1/13 • Number of events 1 • 5 years
|
100.0%
1/1 • Number of events 1 • 5 years
|
0.00%
0/1 • 5 years
|
3.8%
8/213 • Number of events 8 • 5 years
|
7.1%
6/85 • Number of events 7 • 5 years
|
0.00%
0/2 • 5 years
|
50.0%
1/2 • Number of events 1 • 5 years
|
|
Nervous system disorders
Neurotoxicity
|
16.7%
2/12 • Number of events 4 • 5 years
|
0.00%
0/13 • 5 years
|
0.00%
0/1 • 5 years
|
0.00%
0/1 • 5 years
|
5.2%
11/213 • Number of events 11 • 5 years
|
3.5%
3/85 • Number of events 3 • 5 years
|
0.00%
0/2 • 5 years
|
0.00%
0/2 • 5 years
|
|
Gastrointestinal disorders
Mucositis
|
16.7%
2/12 • Number of events 2 • 5 years
|
0.00%
0/13 • 5 years
|
0.00%
0/1 • 5 years
|
0.00%
0/1 • 5 years
|
6.1%
13/213 • Number of events 13 • 5 years
|
2.4%
2/85 • Number of events 2 • 5 years
|
0.00%
0/2 • 5 years
|
0.00%
0/2 • 5 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/12 • 5 years
|
0.00%
0/13 • 5 years
|
0.00%
0/1 • 5 years
|
0.00%
0/1 • 5 years
|
5.6%
12/213 • Number of events 12 • 5 years
|
4.7%
4/85 • Number of events 4 • 5 years
|
0.00%
0/2 • 5 years
|
0.00%
0/2 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
0.00%
0/12 • 5 years
|
0.00%
0/13 • 5 years
|
0.00%
0/1 • 5 years
|
0.00%
0/1 • 5 years
|
4.7%
10/213 • Number of events 10 • 5 years
|
7.1%
6/85 • Number of events 6 • 5 years
|
0.00%
0/2 • 5 years
|
0.00%
0/2 • 5 years
|
Additional Information
Dr. Daniel J.Weisdorf, M.D
Masonic Cancer Center, University of Minnesota
Phone: 612 624-3101
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place