TriangleNCT01231412 · OUTCOME
Number of Patients With Chronic Extensive 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
- Up to 1 year
What was measured
Number of patients who developed chronic extensive GVHD post-transplant. The diagnosis of chronic GVHD requires at least one manifestation that is distinctive for chronic GVHD as opposed to acute GVHD. In all cases, infection and others causes must be ruled out in the differential diagnosis of chronic GVHD.
Analysis population: One subject on Arm II aborted transplant during conditioning and subsequently went on to transplant on a different study. This subject was counted towards accrual but not evaluated with respect to outcome measures.
Groups in this outcome
Arm I (MMF and CSP)
Patients receive FLU IV over 30 minutes on days -4 to -2. Patients also receive CSP PO BID on days -3 to 96 with taper to day 150 and MMF PO TID daily on days 0-29 and then BID on days 30-150 with taper to day 180. Patients undergo allogeneic PBSCT on day 0 following the TBI. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT Cyclosporine: Given PO or IV Fludarabine Phosphate: Given IV Mycophenolate Mofetil: Given PO Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT Total-Body Irradiation: Undergo TBI
Arm II (MMF, CSP, and Sirolimus)
Patients receive FLU and CSP as in Arm I and sirolimus PO QD on days -3 to 150 with taper to day 180. Patients also receive MMF PO TID on days 0-29 and then BID on days 30-40. MMF will then be discontinued without taper unless GVHD or disease relapse/progression occurs. Patients undergo allogeneic PBSCT on day 0 following the TBI. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT Cyclosporine: Given PO or IV Fludarabine Phosphate: Given IV Mycophenolate Mofetil: Given PO Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT Sirolimus: Given PO Total-Body Irradiation: Undergo TBI
Arm 0 (CSP and Sirolimus)
Patients receive CSP orally (PO) twice daily (BID) on days -3 to 96 with taper to day 150 and and sirolimus PO once daily (QD) on days -3 to 150 with taper to day 180. Arm removed as of 14-Sep-2011
| Group | Source count |
|---|---|
| Arm I (MMF and CSP) | 77 |
| Arm II (MMF, CSP, and Sirolimus) | 90 |
| Arm 0 (CSP and Sirolimus) | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (MMF and CSP) | 38 | Not reported | Not reported | Not reported | Not reported |
| Arm II (MMF, CSP, and Sirolimus) | 43 | Not reported | Not reported | Not reported | Not reported |
| Arm 0 (CSP and Sirolimus) | 3 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 38
- group Id
- OG001
- value
- 43
- group Id
- OG002
- value
- 3
- denoms
- counts
- group Id
- OG000
- value
- 77
- group Id
- OG001
- value
- 90
- group Id
- OG002
- value
- 6
- units
- Participants
- description
- Number of patients who developed chronic extensive GVHD post-transplant. The diagnosis of chronic GVHD requires at least one manifestation that is distinctive for chronic GVHD as opposed to acute GVHD. In all cases, infection and others causes must be ruled out in the differential diagnosis of chronic GVHD.
- groups
- description
- Patients receive FLU IV over 30 minutes on days -4 to -2. Patients also receive CSP PO BID on days -3 to 96 with taper to day 150 and MMF PO TID daily on days 0-29 and then BID on days 30-150 with taper to day 180. Patients undergo allogeneic PBSCT on day 0 following the TBI. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT Cyclosporine: Given PO or IV Fludarabine Phosphate: Given IV Mycophenolate Mofetil: Given PO Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT Total-Body Irradiation: Undergo TBI
- id
- OG000
- title
- Arm I (MMF and CSP)
- description
- Patients receive FLU and CSP as in Arm I and sirolimus PO QD on days -3 to 150 with taper to day 180. Patients also receive MMF PO TID on days 0-29 and then BID on days 30-40. MMF will then be discontinued without taper unless GVHD or disease relapse/progression occurs. Patients undergo allogeneic PBSCT on day 0 following the TBI. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT Cyclosporine: Given PO or IV Fludarabine Phosphate: Given IV Mycophenolate Mofetil: Given PO Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT Sirolimus: Given PO Total-Body Irradiation: Undergo TBI
- id
- OG001
- title
- Arm II (MMF, CSP, and Sirolimus)
- description
- Patients receive CSP orally (PO) twice daily (BID) on days -3 to 96 with taper to day 150 and and sirolimus PO once daily (QD) on days -3 to 150 with taper to day 180. Arm removed as of 14-Sep-2011
- id
- OG002
- title
- Arm 0 (CSP and Sirolimus)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- One subject on Arm II aborted transplant during conditioning and subsequently went on to transplant on a different study. This subject was counted towards accrual but not evaluated with respect to outcome measures.
- reporting Status
- POSTED
- time Frame
- Up to 1 year
- title
- Number of Patients With Chronic Extensive GVHD
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice