TriangleNCT00245037 · OUTCOME
Acute Graft-Versus-Host Disease (aGVHD) 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
- Day 100, Month 6
What was measured
Grading of Acute GVHD: Severity of Individual Organ Involvement: Skin * 1 a maculopapular eruption involving less than 25% of the body surface * 2 a maculopapular eruption involving 25-50% of the body surface * 3 generalized erythroderma * 4 generalized erythroderma with bullous formation and/or with desquamation Liver * 1 bilirubin 2.0-3.0mg/100mL * 2 bilirubin 3-5.9mg/100mL * 3 bilirubin 6-14.9mg/100mL * 4 bilirubin \>15mg/100mL Gut Diarrhea is graded +1 to +4 in severity. Nausea/vomiting and/or anorexia caused by GVHD is assigned as +1 in severity Diarrhea * 1 \<1000mL of liquid stool/day * 2 \>1,000mL of stool/day * 3 \>1,500mL of stool/day * 4 2,000mL of stool/day, severe abdominal pain, with or without ileus Severity of GVHD: Grade 1 +1 to +2 skin rash; No gut or liver involvement Grade 2 +1 to +3 skin rash;+1 GI involvement and/or +1 liver
Analysis population: This is cumulative incidence of grades 2-4 aGVHD at 100 days and at 6 months. Out of the total number of participants, grades 2-4 aGVHD occurred in 79 patients.
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
Day 100
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI) | 55 | Not reported | Not reported | Not reported | Not reported |
Month 6
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI) | 60 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 55
- title
- Day 100
- categories
- measurements
- group Id
- OG000
- value
- 60
- title
- Month 6
- denoms
- counts
- group Id
- OG000
- value
- 147
- units
- Participants
- description
- Grading of Acute GVHD: Severity of Individual Organ Involvement: Skin * 1 a maculopapular eruption involving less than 25% of the body surface * 2 a maculopapular eruption involving 25-50% of the body surface * 3 generalized erythroderma * 4 generalized erythroderma with bullous formation and/or with desquamation Liver * 1 bilirubin 2.0-3.0mg/100mL * 2 bilirubin 3-5.9mg/100mL * 3 bilirubin 6-14.9mg/100mL * 4 bilirubin \>15mg/100mL Gut Diarrhea is graded +1 to +4 in severity. Nausea/vomiting and/or anorexia caused by GVHD is assigned as +1 in severity Diarrhea * 1 \<1000mL of liquid stool/day * 2 \>1,000mL of stool/day * 3 \>1,500mL of stool/day * 4 2,000mL of stool/day, severe abdominal pain, with or without ileus Severity of GVHD: Grade 1 +1 to +2 skin rash; No gut or liver involvement Grade 2 +1 to +3 skin rash;+1 GI involvement and/or +1 liver
- 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 cumulative incidence of grades 2-4 aGVHD at 100 days and at 6 months. Out of the total number of participants, grades 2-4 aGVHD occurred in 79 patients.
- reporting Status
- POSTED
- time Frame
- Day 100, Month 6
- title
- Acute Graft-Versus-Host Disease (aGVHD) Outcome
- type
- SECONDARY
- unit Of Measure
- percentage of analyzed participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice