TriangleNCT03128359 · OUTCOME
Acute Graft Versus Host Disease (aGVHD) of Grades 2-4 According to the Consensus Grading
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of probability
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to 100 days post-stem cell infusion
What was measured
Acute graft versus host disease is graded according to the 1994 Keystone Consensus Grading. aGVHD grade was evaluated from day 0 through 100 days post-transplant. The first day of acute GVHD onset at grades 2-4 was used to calculate the cumulative incidence. Relapse/death prior to onset was considered competing events.
Groups in this outcome
Regimen A (Fludarabine, Melphalan, PBSC HCT, GVHD Prophylaxis)
Patients receive fludarabine phosphate IV over 60 minutes on days -7 to -3 and melphalan hydrochloride IV over 20 minutes on day -2. Patients undergo PBSC HCT on day 0. Patients receive cyclophosphamide IV over 1-2 hours on days 3-4, mycophenolate mofetil IV or PO TID beginning on days 5 and stopping on day 35 if no severe GVHD is present-35, and tacrolimus IV continuously on days 5-180 with a taper beginning on day 90 in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Hematopoietic Cell Transplantation: Undergo PBSC HCT Laboratory Biomarker Analysis: Correlative studies Melphalan Hydrochloride: Given IV Mycophenolate Mofetil: Given IV or PO Peripheral Blood Stem Cell Transplantation: Undergo PBSC HCT Quality-of-Life Assessment: Ancillary studies Tacrolimus: Given IV
Regimen C (Fludarabine, TBI, PBSC HCT, GVHD Prophylaxis)
Patients receive fludarabine phosphate IV over 60 minutes on days -7 to -5 and TBI BID on days -4 to -1. Patients undergo PBSC HCT on day 0. Patients receive cyclophosphamide IV over 1-2 hours on days 3-4, mycophenolate mofetil IV or PO TID beginning on days 5 and stopping on day 35 if no severe GVHD is present-35, and tacrolimus IV continuously on days 5-180 with a taper beginning on day 90 in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Hematopoietic Cell Transplantation: Undergo PBSC HCT Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Peripheral Blood Stem Cell Transplantation: Undergo PBSC HCT Quality-of-Life Assessment: Ancillary studies Tacrolimus: Given IV Total-Body Irradiation: Undergo TBI
| Group | Source count |
|---|---|
| Regimen A (Fludarabine, Melphalan, PBSC HCT, GVHD Prophylaxis) | 19 |
| Regimen C (Fludarabine, TBI, PBSC HCT, GVHD Prophylaxis) | 19 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Regimen A (Fludarabine, Melphalan, PBSC HCT, GVHD Prophylaxis) | 47 | Not reported | 29 | 76 | Not reported |
| Regimen C (Fludarabine, TBI, PBSC HCT, GVHD Prophylaxis) | 53 | Not reported | 34 | 81 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 29
- upper Limit
- 76
- value
- 47
- group Id
- OG001
- lower Limit
- 34
- upper Limit
- 81
- value
- 53
- denoms
- counts
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 19
- units
- Participants
- description
- Acute graft versus host disease is graded according to the 1994 Keystone Consensus Grading. aGVHD grade was evaluated from day 0 through 100 days post-transplant. The first day of acute GVHD onset at grades 2-4 was used to calculate the cumulative incidence. Relapse/death prior to onset was considered competing events.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive fludarabine phosphate IV over 60 minutes on days -7 to -3 and melphalan hydrochloride IV over 20 minutes on day -2. Patients undergo PBSC HCT on day 0. Patients receive cyclophosphamide IV over 1-2 hours on days 3-4, mycophenolate mofetil IV or PO TID beginning on days 5 and stopping on day 35 if no severe GVHD is present-35, and tacrolimus IV continuously on days 5-180 with a taper beginning on day 90 in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Hematopoietic Cell Transplantation: Undergo PBSC HCT Laboratory Biomarker Analysis: Correlative studies Melphalan Hydrochloride: Given IV Mycophenolate Mofetil: Given IV or PO Peripheral Blood Stem Cell Transplantation: Undergo PBSC HCT Quality-of-Life Assessment: Ancillary studies Tacrolimus: Given IV
- id
- OG000
- title
- Regimen A (Fludarabine, Melphalan, PBSC HCT, GVHD Prophylaxis)
- description
- Patients receive fludarabine phosphate IV over 60 minutes on days -7 to -5 and TBI BID on days -4 to -1. Patients undergo PBSC HCT on day 0. Patients receive cyclophosphamide IV over 1-2 hours on days 3-4, mycophenolate mofetil IV or PO TID beginning on days 5 and stopping on day 35 if no severe GVHD is present-35, and tacrolimus IV continuously on days 5-180 with a taper beginning on day 90 in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Hematopoietic Cell Transplantation: Undergo PBSC HCT Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Peripheral Blood Stem Cell Transplantation: Undergo PBSC HCT Quality-of-Life Assessment: Ancillary studies Tacrolimus: Given IV Total-Body Irradiation: Undergo TBI
- id
- OG001
- title
- Regimen C (Fludarabine, TBI, PBSC HCT, GVHD Prophylaxis)
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- Up to 100 days post-stem cell infusion
- title
- Acute Graft Versus Host Disease (aGVHD) of Grades 2-4 According to the Consensus Grading
- type
- SECONDARY
- unit Of Measure
- percentage of probability
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Preserved source evidence · Not medical advice