TriangleNCT03220022 · OUTCOME
Complete Response Rates
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 5 years
What was measured
The complete response rates and their corresponding 95% confidence intervals will be calculated for participants with AIDS-related lymphomas (ARL) treated with combination ibrutinib and rituximab (R)-dose adjusted (da)-etoposide, prednisone, vincristine sulfate, cyclophosphamide and doxorubicin hydrochloride (EPOCH). Response is currently assessed on the basis of clinical, radiologic, and pathologic (i.e., bone marrow) criteria. Radiologic response will be based on the Lugano Classification. Complete metabolic response with Score 1, 2, or 3 with or without a residual mass on 5PS. Partial metabolic response with Score 4 or 5† with reduced uptake compared with baseline and residual mass(es) of any size. Overall Response (OR) consists of complete response and partial response.
Analysis population: Participants with response assessment
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 | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion Cohort | 36 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 36
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 40
- units
- Participants
- description
- The complete response rates and their corresponding 95% confidence intervals will be calculated for participants with AIDS-related lymphomas (ARL) treated with combination ibrutinib and rituximab (R)-dose adjusted (da)-etoposide, prednisone, vincristine sulfate, cyclophosphamide and doxorubicin hydrochloride (EPOCH). Response is currently assessed on the basis of clinical, radiologic, and pathologic (i.e., bone marrow) criteria. Radiologic response will be based on the Lugano Classification. Complete metabolic response with Score 1, 2, or 3 with or without a residual mass on 5PS. Partial metabolic response with Score 4 or 5† with reduced uptake compared with baseline and residual mass(es) of any size. Overall Response (OR) consists of complete response and partial response.
- 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
- COUNT_OF_PARTICIPANTS
- population Description
- Participants with response assessment
- reporting Status
- POSTED
- time Frame
- Up to 5 years
- title
- Complete Response Rates
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice