NCT03480360 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- groups
- description
- Cyclophosphamide, fludarabine, total body irradiation, immune suppression including tacrolimus and cellcept, Granulocyte colony-stimulating factor (G-CSF), and peripheral blood transplant Cyclophosphamide: 14.5 mg/kg for 2 days (days -6, -5) and then 50 mg/kg for two days (days 3, 4) Fludarabine: 30 mg/m2 daily for 5 days Total Body Irradiation: 200 centigray (cGy) for one day (day -1) Tacrolimus: 1 mg IV daily, (or the oral equivalent) adjusted to achieve a level between 5 and 15 ng/ml. If there is no evidence of GVHD, discontinue Tacrolimus by Day 180. cellcept: dose at 15 mg/kg po three times per day (maximum dose of 3 grams/day). Stop Cellcept at Day 35 following transplantation. g-csf: 5 mcg/kg/d starting day 5 and continue until Absolute Neutrophil Count (ANC) \> 1000/mcL for 3 days. Peripheral Blood Transplant: cell dose goal: \< 5 x 106 Hematopoietic progenitor cell antigen CD34+ cells/kg recipient weight
- id
- FG000
- title
- Johns Hopkins' Conditioning Regimen
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 2
- type
- Death
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 20
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 18
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 2
- type
- NOT COMPLETED
- title
- Overall Study
- recruitment Details
- 21 individuals signed consent. 1 individual was deemed ineligible during screening. Therefore 20 individuals were evaluated for the primary endpoint.
Complete source fields
- groups
- description
- Cyclophosphamide, fludarabine, total body irradiation, immune suppression including tacrolimus and cellcept, Granulocyte colony-stimulating factor (G-CSF), and peripheral blood transplant Cyclophosphamide: 14.5 mg/kg for 2 days (days -6, -5) and then 50 mg/kg for two days (days 3, 4) Fludarabine: 30 mg/m2 daily for 5 days Total Body Irradiation: 200 centigray (cGy) for one day (day -1) Tacrolimus: 1 mg IV daily, (or the oral equivalent) adjusted to achieve a level between 5 and 15 ng/ml. If there is no evidence of GVHD, discontinue Tacrolimus by Day 180. cellcept: dose at 15 mg/kg po three times per day (maximum dose of 3 grams/day). Stop Cellcept at Day 35 following transplantation. g-csf: 5 mcg/kg/d starting day 5 and continue until Absolute Neutrophil Count (ANC) \> 1000/mcL for 3 days. Peripheral Blood Transplant: cell dose goal: \< 5 x 106 Hematopoietic progenitor cell antigen CD34+ cells/kg recipient weight
- id
- FG000
- title
- Johns Hopkins' Conditioning Regimen
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 2
- type
- Death
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 20
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 18
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 2
- type
- NOT COMPLETED
- title
- Overall Study
- recruitment Details
- 21 individuals signed consent. 1 individual was deemed ineligible during screening. Therefore 20 individuals were evaluated for the primary endpoint.
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Preserved source evidence · Not medical advice
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