TriangleNCT00047060 · OUTCOME
Number of Participant Who Experienced Chronic Graft Versus Host Disease
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Day 100 up to 3 years
What was measured
Number of participant who experienced chronic graft versus host disease (GVHD) following stem cell transplant The diagnosis of clinical features of chronic-GVHD was determined prospectively and classified retrospectively into limited or extensive based on the Revised Seattle Classification. Chronic GvHD severity categorized as "limited" is defined as: localized skin lesions with or without limited hepatic involvement and "extensive" is defined as: generalized skin involvement, major hepatic complications, or involvement of any other organ.
Analysis population: The analyses included only those participants that engrafted and survived over 100 days
Groups in this outcome
Stem Cell Transplant Therapy With Campath-1H
Subjects received a nonmyeloablative preparative regimen of alemtuzumab 30mg IV three times a week for two weeks followed by fludarabine 25mg/m\^2/day for five days followed by a PBPC graft targeted to deliver ≥ 5x10\^6 CD34+ cells/kg. Cyclosporine A (CSA) for GVHD prophylaxis will be used initially with target CSA levels in the therapeutic range (200 -400 ng/ml).
| Group | Source count |
|---|---|
| Stem Cell Transplant Therapy With Campath-1H | 5 |
Reported measurements
Limited
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Stem Cell Transplant Therapy With Campath-1H | 3 | Not reported | Not reported | Not reported | Not reported |
Extensive
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Stem Cell Transplant Therapy With Campath-1H | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- title
- Limited
- categories
- measurements
- group Id
- OG000
- value
- 0
- title
- Extensive
- denoms
- counts
- group Id
- OG000
- value
- 5
- units
- Participants
- description
- Number of participant who experienced chronic graft versus host disease (GVHD) following stem cell transplant The diagnosis of clinical features of chronic-GVHD was determined prospectively and classified retrospectively into limited or extensive based on the Revised Seattle Classification. Chronic GvHD severity categorized as "limited" is defined as: localized skin lesions with or without limited hepatic involvement and "extensive" is defined as: generalized skin involvement, major hepatic complications, or involvement of any other organ.
- groups
- description
- Subjects received a nonmyeloablative preparative regimen of alemtuzumab 30mg IV three times a week for two weeks followed by fludarabine 25mg/m\^2/day for five days followed by a PBPC graft targeted to deliver ≥ 5x10\^6 CD34+ cells/kg. Cyclosporine A (CSA) for GVHD prophylaxis will be used initially with target CSA levels in the therapeutic range (200 -400 ng/ml).
- id
- OG000
- title
- Stem Cell Transplant Therapy With Campath-1H
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The analyses included only those participants that engrafted and survived over 100 days
- reporting Status
- POSTED
- time Frame
- Day 100 up to 3 years
- title
- Number of Participant Who Experienced Chronic Graft Versus Host Disease
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice