TriangleNCT03220022 · OUTCOME
Progression Free Survival (PFS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- 2 years
What was measured
PFS will be estimated using Kaplan Meier method, as well as, their corresponding 95% confidence intervals. Progressive disease requires at least 1 of the following Perpendicular diameters: An individual node/lesion must be abnormal with: longest diameter 1.5 cm and Increase by 50% from perpendicular diameters nadir and an increase in longest diameter or shortest diameter from nadir 0.5 cm for lesions 2 cm 1.0 cm for lesions 2 cm. In the setting of splenomegaly, the splenic length must increase by 50% of the extent of its prior increase beyond baseline (e.g., a 15-cm spleen must increase to 16 cm). If no prior splenomegaly, must increase by at least 2 cm from baseline.
Analysis population: Participants received study treatment (ibrutinib plus R-da-EPOCH)
Groups in this outcome
Dose-finding Cohort
Each participant in the dose-finding cohort must have completed at least cycle 1 (or 21 days) of ibrutinib plus rituximab (R)-dose adjusted (da)-etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin (EPOCH). Starting dose of ibrutinib is 560 mg PO.
Dose Expansion Cohort
Each participant in the dose expansion cohort may receive treatment for a maximum of 6 cycles (21-day cycle length) of ibrutinib plus rituximab (R)-dose adjusted (da)-etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin (EPOCH). MTD of ibrutinib is 560 mg PO.
| Group | Source count |
|---|---|
| Dose-finding Cohort | 3 |
| Dose Expansion Cohort | 40 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose-finding Cohort | 33.3 | Not reported | 0.9 | 77.4 | Not reported |
| Dose Expansion Cohort | 82.7 | Not reported | 65.4 | 91.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.9
- upper Limit
- 77.4
- value
- 33.3
- group Id
- OG001
- lower Limit
- 65.4
- upper Limit
- 91.9
- value
- 82.7
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 40
- units
- Participants
- description
- PFS will be estimated using Kaplan Meier method, as well as, their corresponding 95% confidence intervals. Progressive disease requires at least 1 of the following Perpendicular diameters: An individual node/lesion must be abnormal with: longest diameter 1.5 cm and Increase by 50% from perpendicular diameters nadir and an increase in longest diameter or shortest diameter from nadir 0.5 cm for lesions 2 cm 1.0 cm for lesions 2 cm. In the setting of splenomegaly, the splenic length must increase by 50% of the extent of its prior increase beyond baseline (e.g., a 15-cm spleen must increase to 16 cm). If no prior splenomegaly, must increase by at least 2 cm from baseline.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Each participant in the dose-finding cohort must have completed at least cycle 1 (or 21 days) of ibrutinib plus rituximab (R)-dose adjusted (da)-etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin (EPOCH). Starting dose of ibrutinib is 560 mg PO.
- id
- OG000
- title
- Dose-finding Cohort
- description
- Each participant in the dose expansion cohort may receive treatment for a maximum of 6 cycles (21-day cycle length) of ibrutinib plus rituximab (R)-dose adjusted (da)-etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin (EPOCH). MTD of ibrutinib is 560 mg PO.
- id
- OG001
- title
- Dose Expansion Cohort
- param Type
- NUMBER
- population Description
- Participants received study treatment (ibrutinib plus R-da-EPOCH)
- reporting Status
- POSTED
- time Frame
- 2 years
- title
- Progression Free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice