TriangleNCT00105001 · OUTCOME
Number of Participants With Grades II-IV Acute GVHD
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
- 150 days after transplant
What was measured
Number of patients with grades II-IV acute GVHD aGVHD Stages Skin: 1. a maculopapular eruption involving \< 25% BSA 2. a maculopapular eruption involving 25 - 50% BSA 3. generalized erythroderma 4. generalized erythroderma w/ bullous formation and often w/ desquamation Liver: 1. bilirubin 2.0 - 3.0 mg/100 mL 2. bilirubin 3 - 5.9 mg/100 mL 3. bilirubin 6 - 14.9 mg/100 mL 4. bilirubin \> 15 mg/100 mL Gut: Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients w/ visible bloody diarrhea are at least stage 2 gut and grade 3 overall. aGVHD Grades Grade II: Stage 1 - 2 skin w/ no gut/liver involvement Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 w/ extreme constitutional symptoms or death
Analysis population: Two subjects counted towards accrual but did not proceed to transplant and thus were not evaluable.
Groups in this outcome
Arm I (MMF and Tacrolimus)
Patients receive tacrolimus IV or PO every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD. Fludarabine Phosphate: Given IV Total-Body Irradiation: Undergo total-body irradiation Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Tacrolimus: Given IV or PO Mycophenolate Mofetil: Given PO
Arm II (MMF and Tacrolimus Alternate Schedule)
Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD. Fludarabine Phosphate: Given IV Total-Body Irradiation: Undergo total-body irradiation Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Tacrolimus: Given IV or PO Mycophenolate Mofetil: Given PO
Arm III (MMF, Tacrolimus, and Sirolimus)
Patients receive tacrolimus and MMF as in arm II. Patients also receive sirolimus PO once daily on days -3 to 80. Fludarabine Phosphate: Given IV Total-Body Irradiation: Undergo total-body irradiation Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Tacrolimus: Given IV or PO Mycophenolate Mofetil: Given PO Sirolimus: Given PO
| Group | Source count |
|---|---|
| Arm I (MMF and Tacrolimus) | 69 |
| Arm II (MMF and Tacrolimus Alternate Schedule) | 71 |
| Arm III (MMF, Tacrolimus, and Sirolimus) | 68 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (MMF and Tacrolimus) | 44 | Not reported | Not reported | Not reported | Not reported |
| Arm II (MMF and Tacrolimus Alternate Schedule) | 34 | Not reported | Not reported | Not reported | Not reported |
| Arm III (MMF, Tacrolimus, and Sirolimus) | 32 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Num Sides
- TWO_SIDED
- group Ids
- OG000
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.09
- p Value Comment
- Overall test of homogeneity among arms, reflecting events over the entire period of follow-up
- statistical Method
- Regression, Cox
- ci Lower Limit
- 0.4
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.1
- estimate Comment
- HR for Arm II relative to Arm I, reflecting events over the entire period of follow-u\[
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.10
- param Type
- Hazard Ratio (HR)
- param Value
- 0.69
- statistical Method
- Regression, Cox
- ci Lower Limit
- 0.6
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.0
- estimate Comment
- HR for Arm III relative to Arm I, reflecting events over the entire period of follow-up
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.04
- param Type
- Hazard Ratio (HR)
- param Value
- 0.62
- statistical Method
- Regression, Cox
Complete source fields
- analyses
- ci Num Sides
- TWO_SIDED
- group Ids
- OG000
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.09
- p Value Comment
- Overall test of homogeneity among arms, reflecting events over the entire period of follow-up
- statistical Method
- Regression, Cox
- ci Lower Limit
- 0.4
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.1
- estimate Comment
- HR for Arm II relative to Arm I, reflecting events over the entire period of follow-u\[
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.10
- param Type
- Hazard Ratio (HR)
- param Value
- 0.69
- statistical Method
- Regression, Cox
- ci Lower Limit
- 0.6
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.0
- estimate Comment
- HR for Arm III relative to Arm I, reflecting events over the entire period of follow-up
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.04
- param Type
- Hazard Ratio (HR)
- param Value
- 0.62
- statistical Method
- Regression, Cox
- classes
- categories
- measurements
- group Id
- OG000
- value
- 44
- group Id
- OG001
- value
- 34
- group Id
- OG002
- value
- 32
- denoms
- counts
- group Id
- OG000
- value
- 69
- group Id
- OG001
- value
- 71
- group Id
- OG002
- value
- 68
- units
- Participants
- description
- Number of patients with grades II-IV acute GVHD aGVHD Stages Skin: 1. a maculopapular eruption involving \< 25% BSA 2. a maculopapular eruption involving 25 - 50% BSA 3. generalized erythroderma 4. generalized erythroderma w/ bullous formation and often w/ desquamation Liver: 1. bilirubin 2.0 - 3.0 mg/100 mL 2. bilirubin 3 - 5.9 mg/100 mL 3. bilirubin 6 - 14.9 mg/100 mL 4. bilirubin \> 15 mg/100 mL Gut: Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients w/ visible bloody diarrhea are at least stage 2 gut and grade 3 overall. aGVHD Grades Grade II: Stage 1 - 2 skin w/ no gut/liver involvement Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 w/ extreme constitutional symptoms or death
- groups
- description
- Patients receive tacrolimus IV or PO every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD. Fludarabine Phosphate: Given IV Total-Body Irradiation: Undergo total-body irradiation Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Tacrolimus: Given IV or PO Mycophenolate Mofetil: Given PO
- id
- OG000
- title
- Arm I (MMF and Tacrolimus)
- description
- Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD. Fludarabine Phosphate: Given IV Total-Body Irradiation: Undergo total-body irradiation Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Tacrolimus: Given IV or PO Mycophenolate Mofetil: Given PO
- id
- OG001
- title
- Arm II (MMF and Tacrolimus Alternate Schedule)
- description
- Patients receive tacrolimus and MMF as in arm II. Patients also receive sirolimus PO once daily on days -3 to 80. Fludarabine Phosphate: Given IV Total-Body Irradiation: Undergo total-body irradiation Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Tacrolimus: Given IV or PO Mycophenolate Mofetil: Given PO Sirolimus: Given PO
- id
- OG002
- title
- Arm III (MMF, Tacrolimus, and Sirolimus)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Two subjects counted towards accrual but did not proceed to transplant and thus were not evaluable.
- reporting Status
- POSTED
- time Frame
- 150 days after transplant
- title
- Number of Participants With Grades II-IV Acute GVHD
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice