NCT03096782 · 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
- 6
- units
- Participants
- groups
- description
- All patients received Busulfan as per standard of care. Busulfan test dose can be administered either as an outpatient prior to admission or as an inpatient on Day -10. Busulfan pharmacokinetics will be performed with the test dose and the first dose on Day -7 per standard of care. The doses of Days -6, -5, and -4 will be subsequently adjusted to target an AUC of 4,000 microMol.min-1. In the event that PK adjusting were not possible a dose of busulfan of 130 mg/m2 will be administered. GVHD PROPHYLAXIS: All patients also receive mycofenolate mofetil IV over 2 hours or PO BID on days -3 with a taper beginning on day 100 in the absence of GVHD, tacrolimus IV or PO starting on day -2 for 6 months in the absence of GVHD, and filgrastim-sndz SC QD starting on day 0 until white blood count begins to recover. Anti-Thymocyte Globulin: Given IV Busulfan: Given IV Clofarabine: Given IV Cyclophosphamide: Given IV Filgrastim-sndz: Given SC Fludarabine: Given IV Melphalan: Given IV Mycophenolate Mofetil: Given IV or PO Rituximab: Given IV Tacrolimus: Given IV Total-Body Irradiation: Undergo total body irradiation Umbilical Cord Blood Transplantation: Undergo cord blood transplant
- id
- BG000
- title
- Chemotherapy and Cord Blood Transfusion
- measures
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- title
- <=18 years
- measurements
- group Id
- BG000
- value
- 6
- title
- Between 18 and 65 years
- measurements
- group Id
- BG000
- value
- 0
- title
- >=65 years
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Age, Categorical
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 3
- title
- Female
- measurements
- group Id
- BG000
- value
- 3
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 6
- title
- Not Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 0
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Ethnicity (NIH/OMB)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 6
- title
- United States
- param Type
- NUMBER
- title
- Region of Enrollment
- unit Of Measure
- participants
Complete source fields
- denoms
- counts
- group Id
- BG000
- value
- 6
- units
- Participants
- groups
- description
- All patients received Busulfan as per standard of care. Busulfan test dose can be administered either as an outpatient prior to admission or as an inpatient on Day -10. Busulfan pharmacokinetics will be performed with the test dose and the first dose on Day -7 per standard of care. The doses of Days -6, -5, and -4 will be subsequently adjusted to target an AUC of 4,000 microMol.min-1. In the event that PK adjusting were not possible a dose of busulfan of 130 mg/m2 will be administered. GVHD PROPHYLAXIS: All patients also receive mycofenolate mofetil IV over 2 hours or PO BID on days -3 with a taper beginning on day 100 in the absence of GVHD, tacrolimus IV or PO starting on day -2 for 6 months in the absence of GVHD, and filgrastim-sndz SC QD starting on day 0 until white blood count begins to recover. Anti-Thymocyte Globulin: Given IV Busulfan: Given IV Clofarabine: Given IV Cyclophosphamide: Given IV Filgrastim-sndz: Given SC Fludarabine: Given IV Melphalan: Given IV Mycophenolate Mofetil: Given IV or PO Rituximab: Given IV Tacrolimus: Given IV Total-Body Irradiation: Undergo total body irradiation Umbilical Cord Blood Transplantation: Undergo cord blood transplant
- id
- BG000
- title
- Chemotherapy and Cord Blood Transfusion
- measures
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- title
- <=18 years
- measurements
- group Id
- BG000
- value
- 6
- title
- Between 18 and 65 years
- measurements
- group Id
- BG000
- value
- 0
- title
- >=65 years
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Age, Categorical
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 3
- title
- Female
- measurements
- group Id
- BG000
- value
- 3
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 6
- title
- Not Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 0
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Ethnicity (NIH/OMB)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 6
- title
- United States
- param Type
- NUMBER
- title
- Region of Enrollment
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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