NCT00075478 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- groups
- description
- Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins. total-body irradiation: Undergo TBI fludarabine phosphate: Given IV mycophenolate mofetil: Given PO cyclosporine: Given PO peripheral blood stem cell transplantation: Undergo transplantation
- id
- FG000
- title
- Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)
- description
- Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins. total-body irradiation: Undergo TBI mycophenolate mofetil: Given PO cyclosporine: Given PO peripheral blood stem cell transplantation: Undergo transplantation
- id
- FG001
- title
- Arm II (TBI, Transplant, GVHD Prophylaxis)
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 0
- type
- not eligible
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- type
- Physician Decision
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 42
- group Id
- FG001
- num Subjects
- 45
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 41
- group Id
- FG001
- num Subjects
- 44
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 1
- type
- NOT COMPLETED
- title
- Overall Study
Complete source fields
- groups
- description
- Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins. total-body irradiation: Undergo TBI fludarabine phosphate: Given IV mycophenolate mofetil: Given PO cyclosporine: Given PO peripheral blood stem cell transplantation: Undergo transplantation
- id
- FG000
- title
- Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)
- description
- Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins. total-body irradiation: Undergo TBI mycophenolate mofetil: Given PO cyclosporine: Given PO peripheral blood stem cell transplantation: Undergo transplantation
- id
- FG001
- title
- Arm II (TBI, Transplant, GVHD Prophylaxis)
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 0
- type
- not eligible
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- type
- Physician Decision
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 42
- group Id
- FG001
- num Subjects
- 45
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 41
- group Id
- FG001
- num Subjects
- 44
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 1
- type
- NOT COMPLETED
- title
- Overall Study
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Preserved source evidence · Not medical advice
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