NCT00741455 · BASELINE
Baseline characteristics
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- denoms
- counts
- group Id
- BG000
- value
- 18
- units
- Participants
- groups
- description
- Chemo, stem cell transplantation, HLA-Matched related allogeneic stem cell transplantation, leukapheresis, G-CSF, peripheral blood stem cell transplant, fludarabine, cyclophosphamide, donor lymphocyte infusion, cyclosporine, methotrexate Stem Cell Transplant: Donor: Prior to mobilization, leukapheresis to collect CD3+ cells. The donor will then receive G-CSF (10 mcg/kg/day) with leukapheresis collection of peripheral blood stem cells on days 5, 6 and 7 as needed. Goal of leukapheresis will be \> 5 x 106 CD34+cells/kg of recipient. Patient: Peripheral Blood Stem Cell (PBSC) Transplant. Fludarabine 25mg/m2/d IV over 30 minutes on days -6 to -2, followed by cyclophosphamide 1g/m2/d IV on days -3 and -2. This will be followed by allogeneic stem cell infusion 48 hours later. Donor Lymphocyte Infusion (DLI) and Adjustment of Immunosuppression: Cyclosporine (CSA) and methotrexate (MTX) will be used for GvHD prophylaxis with target CSA levels of 200-400 ng/ml. G-CSF: 10 mcg/k
- id
- BG000
- title
- Study Treatment
- measures
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- title
- <=18 years
- measurements
- group Id
- BG000
- value
- 18
- title
- Between 18 and 65 years
- measurements
- group Id
- BG000
- value
- 0
- title
- >=65 years
- denoms
- counts
- group Id
- BG000
- value
- 18
- units
- Participants
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Age, Categorical
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- lower Limit
- 38
- upper Limit
- 65
- value
- 57
- denoms
- counts
- group Id
- BG000
- value
- 18
- units
- Participants
- dispersion Type
- FULL_RANGE
- param Type
- MEDIAN
- title
- Age, Continuous
- unit Of Measure
- years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 12
- title
- Female
- measurements
- group Id
- BG000
- value
- 6
- title
- Male
- denoms
- counts
- group Id
- BG000
- value
- 18
- units
- Participants
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- denoms
- counts
- group Id
- BG000
- value
- 0
- units
- Participants
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Race and Ethnicity were not collected from any participant.
- title
- Race and Ethnicity Not Collected
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 18
- denoms
- counts
- group Id
- BG000
- value
- 18
- units
- Participants
- title
- United States
- param Type
- NUMBER
- title
- Region of Enrollment
- unit Of Measure
- participants
Complete source fields
- denoms
- counts
- group Id
- BG000
- value
- 18
- units
- Participants
- groups
- description
- Chemo, stem cell transplantation, HLA-Matched related allogeneic stem cell transplantation, leukapheresis, G-CSF, peripheral blood stem cell transplant, fludarabine, cyclophosphamide, donor lymphocyte infusion, cyclosporine, methotrexate Stem Cell Transplant: Donor: Prior to mobilization, leukapheresis to collect CD3+ cells. The donor will then receive G-CSF (10 mcg/kg/day) with leukapheresis collection of peripheral blood stem cells on days 5, 6 and 7 as needed. Goal of leukapheresis will be \> 5 x 106 CD34+cells/kg of recipient. Patient: Peripheral Blood Stem Cell (PBSC) Transplant. Fludarabine 25mg/m2/d IV over 30 minutes on days -6 to -2, followed by cyclophosphamide 1g/m2/d IV on days -3 and -2. This will be followed by allogeneic stem cell infusion 48 hours later. Donor Lymphocyte Infusion (DLI) and Adjustment of Immunosuppression: Cyclosporine (CSA) and methotrexate (MTX) will be used for GvHD prophylaxis with target CSA levels of 200-400 ng/ml. G-CSF: 10 mcg/k
- id
- BG000
- title
- Study Treatment
- measures
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- title
- <=18 years
- measurements
- group Id
- BG000
- value
- 18
- title
- Between 18 and 65 years
- measurements
- group Id
- BG000
- value
- 0
- title
- >=65 years
- denoms
- counts
- group Id
- BG000
- value
- 18
- units
- Participants
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Age, Categorical
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- lower Limit
- 38
- upper Limit
- 65
- value
- 57
- denoms
- counts
- group Id
- BG000
- value
- 18
- units
- Participants
- dispersion Type
- FULL_RANGE
- param Type
- MEDIAN
- title
- Age, Continuous
- unit Of Measure
- years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 12
- title
- Female
- measurements
- group Id
- BG000
- value
- 6
- title
- Male
- denoms
- counts
- group Id
- BG000
- value
- 18
- units
- Participants
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- denoms
- counts
- group Id
- BG000
- value
- 0
- units
- Participants
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Race and Ethnicity were not collected from any participant.
- title
- Race and Ethnicity Not Collected
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 18
- denoms
- counts
- group Id
- BG000
- value
- 18
- units
- Participants
- title
- United States
- param Type
- NUMBER
- title
- Region of Enrollment
- unit Of Measure
- participants
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Preserved source evidence · Not medical advice
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