TriangleNCT00118352 · OUTCOME
Incidence of Grade III-IV Acute GVHD
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- 100 days after transplant
What was measured
Severity of Individual Organ Involvement Liver: Stage 2 - bilirubin (3-5.9mg/100ml) Stage 3 - bilirubin (6-14.9mg/100ml) Stage 4 - bilirubin \> 15mg/100ml Gut: Diarrhea is graded stage 1 to stage 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as stage 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall Severity of GVHD Grade III - Stage 2 to 4 gastrointestinal involvement and/or Stage 2 to 4 liver involvement with or without a rash Grade IV - Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death
Groups in this outcome
Dose Level 1 (No Campath)
Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0. Total-body irradiation: Undergo low-dose total-body irradiation Fludarabine phosphate: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation
Dose Level 2 (40mg Total Dose Campath)
Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0. Alemtuzumab: Given IV Total-body irradiation: Undergo low-dose total-body irradiation Fludarabine phosphate: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation
Dose Level 3 (60mg Total Dose Campath)
Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0. Alemtuzumab: Given IV Total-body irradiation: Undergo low-dose total-body irradiation Fludarabine phosphate: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation
| Group | Source count |
|---|---|
| Dose Level 1 (No Campath) | 12 |
| Dose Level 2 (40mg Total Dose Campath) | 0 |
| Dose Level 3 (60mg Total Dose Campath) | 0 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Level 1 (No Campath) | 25 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 25
- denoms
- counts
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- units
- Participants
- description
- Severity of Individual Organ Involvement Liver: Stage 2 - bilirubin (3-5.9mg/100ml) Stage 3 - bilirubin (6-14.9mg/100ml) Stage 4 - bilirubin \> 15mg/100ml Gut: Diarrhea is graded stage 1 to stage 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as stage 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall Severity of GVHD Grade III - Stage 2 to 4 gastrointestinal involvement and/or Stage 2 to 4 liver involvement with or without a rash Grade IV - Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death
- groups
- description
- Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0. Total-body irradiation: Undergo low-dose total-body irradiation Fludarabine phosphate: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation
- id
- OG000
- title
- Dose Level 1 (No Campath)
- description
- Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0. Alemtuzumab: Given IV Total-body irradiation: Undergo low-dose total-body irradiation Fludarabine phosphate: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation
- id
- OG001
- title
- Dose Level 2 (40mg Total Dose Campath)
- description
- Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0. Alemtuzumab: Given IV Total-body irradiation: Undergo low-dose total-body irradiation Fludarabine phosphate: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation
- id
- OG002
- title
- Dose Level 3 (60mg Total Dose Campath)
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- 100 days after transplant
- title
- Incidence of Grade III-IV Acute GVHD
- type
- PRIMARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice