TriangleNCT01427881 · OUTCOME
Chronic GVHD Requiring Systemic Immunosuppressive Treatment
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percent of patients
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- At 1 year after transplantation
What was measured
Chronic GVHD will be defined by National Institutes of Health (NIH) criteria and requiring systemic treatment. A reduction in the cumulative incidence of GVHD from \~35% to \~15% at 1 year would represent a reasonable goal. A sample size of 42 patients provides 90% power to observe such a difference with one-side 5% type-1 error.
Groups in this outcome
Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)
PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice. GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126. cyclophosphamide: Given IV cyclosporine: Given IV peripheral blood stem cell transplantation: Undergo allogeneic PBSCT total-body irradiation: Undergo TBI fludarabine phosphate: Given IV busulfan: Given IV allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT
| Group | Source count |
|---|---|
| Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis) | 43 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis) | 16 | Not reported | 5 | 28 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5
- upper Limit
- 28
- value
- 16
- denoms
- counts
- group Id
- OG000
- value
- 43
- units
- Participants
- description
- Chronic GVHD will be defined by National Institutes of Health (NIH) criteria and requiring systemic treatment. A reduction in the cumulative incidence of GVHD from \~35% to \~15% at 1 year would represent a reasonable goal. A sample size of 42 patients provides 90% power to observe such a difference with one-side 5% type-1 error.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice. GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126. cyclophosphamide: Given IV cyclosporine: Given IV peripheral blood stem cell transplantation: Undergo allogeneic PBSCT total-body irradiation: Undergo TBI fludarabine phosphate: Given IV busulfan: Given IV allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT
- id
- OG000
- title
- Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- At 1 year after transplantation
- title
- Chronic GVHD Requiring Systemic Immunosuppressive Treatment
- type
- PRIMARY
- unit Of Measure
- percent of patients
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice