TriangleNCT00245037 · OUTCOME
Chronic Graft-Versus-Host Disease (cGVHD) Outcome
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of analyzed participants
- Interval / dispersion
- Not reported
- Time frame
- Years 1, 2 and 3
What was measured
Grading of Chronic GVHD: Limited: Localized skin involvement and/or hepatic dysfunction due to chronic GVHD Extensive: One or more of the following: Generalized skin involvement Liver histology showing chronic aggressive hepatitis, bridging necrosis or cirrhosis Involvement of the eye: Schirmer's test with \<5 mm wetting Involvement of minor salivary glands or oral mucosa demonstrated on labial biopsy Involvement of any other target organ Chronic GVHD Severity: Mild: Signs and symptoms of cGVHD do not interfere substantially with function and do not progress once appropriately treated with local therapy or standard systemic therapy. Moderate: Signs and symptoms of cGVHD interfere somewhat with function despite appropriate therapy or are progressive through first line systemic therapy. Severe: Signs and symptoms of cGVHD limit function substantially despite appropriate therapy or are progressive through second line systemic therapy
Analysis population: This is a cumulative incidence of cGVHD at 1 year, 2 years, and 3 years. A total of 99 patients (out of 147) developed cGVHD, 86 patients (87%) with extensive stage cGVHD and 13 patients (13%) with limited stage cGVHD.
Groups in this outcome
Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI)
Busulfan 3.2 mg/kg IV on day -5 Fludarabine 30 mg/m2/day x 3 (total dose 90 mg/m2, day -4 to day -2 TBI 200 centigray (cGy) x 1, day 0 Therapeutic allogeneic lymphocytes: A population of lymphocytes therapeutically administered to a recipient individual who is genetically distinct from a donor of the same species. Busulfan: Busulfan is an alkylating chemotherapeutic agent which has been used in many high dose and reduced intensity regimens prior to allogeneic or autologous hematopoietic stem cell transplants. It is active in a wide variety of malignancies and in high-doses it is myeloablative. IV Busulfan is available and diluted and administered per package insert guidelines. Cyclosporine: Cyclosporine is a cyclic polypeptide immunosuppressive agent. It blocks the calcium-dependent calcineurin-mediated nuclear localization of nuclear factor of activated T cells (NFAT) following T-cell activation, thereby inhibiting transactivation of key T-cell response genes including
| Group | Source count |
|---|---|
| Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI) | 147 |
Reported measurements
Year 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI) | 64.6 | Not reported | Not reported | Not reported | Not reported |
Year 2
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI) | 66 | Not reported | Not reported | Not reported | Not reported |
Year 3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI) | 67.3 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 64.6
- title
- Year 1
- categories
- measurements
- group Id
- OG000
- value
- 66
- title
- Year 2
- categories
- measurements
- group Id
- OG000
- value
- 67.3
- title
- Year 3
- denoms
- counts
- group Id
- OG000
- value
- 147
- units
- Participants
- description
- Grading of Chronic GVHD: Limited: Localized skin involvement and/or hepatic dysfunction due to chronic GVHD Extensive: One or more of the following: Generalized skin involvement Liver histology showing chronic aggressive hepatitis, bridging necrosis or cirrhosis Involvement of the eye: Schirmer's test with \<5 mm wetting Involvement of minor salivary glands or oral mucosa demonstrated on labial biopsy Involvement of any other target organ Chronic GVHD Severity: Mild: Signs and symptoms of cGVHD do not interfere substantially with function and do not progress once appropriately treated with local therapy or standard systemic therapy. Moderate: Signs and symptoms of cGVHD interfere somewhat with function despite appropriate therapy or are progressive through first line systemic therapy. Severe: Signs and symptoms of cGVHD limit function substantially despite appropriate therapy or are progressive through second line systemic therapy
- groups
- description
- Busulfan 3.2 mg/kg IV on day -5 Fludarabine 30 mg/m2/day x 3 (total dose 90 mg/m2, day -4 to day -2 TBI 200 centigray (cGy) x 1, day 0 Therapeutic allogeneic lymphocytes: A population of lymphocytes therapeutically administered to a recipient individual who is genetically distinct from a donor of the same species. Busulfan: Busulfan is an alkylating chemotherapeutic agent which has been used in many high dose and reduced intensity regimens prior to allogeneic or autologous hematopoietic stem cell transplants. It is active in a wide variety of malignancies and in high-doses it is myeloablative. IV Busulfan is available and diluted and administered per package insert guidelines. Cyclosporine: Cyclosporine is a cyclic polypeptide immunosuppressive agent. It blocks the calcium-dependent calcineurin-mediated nuclear localization of nuclear factor of activated T cells (NFAT) following T-cell activation, thereby inhibiting transactivation of key T-cell response genes including
- id
- OG000
- title
- Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI)
- param Type
- NUMBER
- population Description
- This is a cumulative incidence of cGVHD at 1 year, 2 years, and 3 years. A total of 99 patients (out of 147) developed cGVHD, 86 patients (87%) with extensive stage cGVHD and 13 patients (13%) with limited stage cGVHD.
- reporting Status
- POSTED
- time Frame
- Years 1, 2 and 3
- title
- Chronic Graft-Versus-Host Disease (cGVHD) Outcome
- type
- SECONDARY
- unit Of Measure
- percentage of analyzed participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice