TriangleNCT05211336 · OUTCOME
Duration of Response (DOR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From date of first response until the date of recurrent or progressive disease is objectively documented, up to a max 2.6 years
What was measured
The duration of response after VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) in primary central nervous system lymphoma (PCNSL) and secondary central nervous system lymphoma (SCNSL) will be determined starting at the date a response is identified and will be estimated using a Kaplan-Meier curve along with a median DOR, and its associated 95% confidence interval. The duration of response (DOR) is measured from the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, death, or, in the absence of progressive disease (PD), date of last assessment. CR is disappearance of all detectable evidence of disease and disease-related symptoms. PR is a ≥50% decrease in the sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses. Progression is appearance of any new nodal lesion.
Groups in this outcome
Lenalidomide+Nivolumab Followed by Venetoclax, Ibrutinib,Prednisone, Obinutuzumab, Lenalidomide-Nivo
Cohort 1, Arm 1: Participants with primary diffuse large B-cell lymphoma of the central nervous system (CNS) primary central nervous system lymphoma (PCNSL) or secondary CNS lymphoma (SCNSL). Experimental - Nivolumab on Day 1 with lenalidomide (days 1-14) for a 21-day cycle. Following Window, VIPOR-Nivo (venetoclax, ibrutinib, prednisone, Obinutuzumab, lenalidomide, and nivolumab) in 21-day cycles for up to 6 cycles.
Cohort 1, Arm 2: Experimental- VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide)
Participants with primary diffuse large B-cell lymphoma of the central nervous system (CNS) primary central nervous system lymphoma (PCNSL) or secondary CNS lymphoma (SCNSL). VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) in 21-day cycles for up to 6 cycles.
| Group | Source count |
|---|---|
| Lenalidomide+Nivolumab Followed by Venetoclax, Ibrutinib,Prednisone, Obinutuzumab, Lenalidomide-Nivo | 4 |
| Cohort 1, Arm 2: Experimental- VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) | 10 |
Reported measurements
Complete Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lenalidomide+Nivolumab Followed by Venetoclax, Ibrutinib,Prednisone, Obinutuzumab, Lenalidomide-Nivo | 21.9 | Not reported | 12.0 | NA | The confidence intervals are generated via the Brookmeyer-Crowley method (if a limit of the interval does not intersect the median, then it is recorded as not able to be estimated with a dash |
| Cohort 1, Arm 2: Experimental- VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) | 7.2 | Not reported | 5.2 | NA | The confidence intervals are generated via the Brookmeyer-Crowley method (if a limit of the interval does not intersect the median, then it is recorded as not able to be estimated with a dash |
Partial Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lenalidomide+Nivolumab Followed by Venetoclax, Ibrutinib,Prednisone, Obinutuzumab, Lenalidomide-Nivo | 4.9 | Not reported | NA | NA | The confidence intervals are generated via the Brookmeyer-Crowley method (if a limit of the interval does not intersect the median, then it is recorded as not able to be estimated with a dash |
| Cohort 1, Arm 2: Experimental- VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) | 4.8 | Not reported | 3.6 | NA | The confidence intervals are generated via the Brookmeyer-Crowley method (if a limit of the interval does not intersect the median, then it is recorded as not able to be estimated with a dash |
Complete source fields
- classes
- categories
- measurements
- comment
- The confidence intervals are generated via the Brookmeyer-Crowley method (if a limit of the interval does not intersect the median, then it is recorded as not able to be estimated with a dash
- group Id
- OG000
- lower Limit
- 12.0
- upper Limit
- NA
- value
- 21.9
- comment
- The confidence intervals are generated via the Brookmeyer-Crowley method (if a limit of the interval does not intersect the median, then it is recorded as not able to be estimated with a dash
- group Id
- OG001
- lower Limit
- 5.2
- upper Limit
- NA
- value
- 7.2
- title
- Complete Response
- categories
- measurements
- comment
- The confidence intervals are generated via the Brookmeyer-Crowley method (if a limit of the interval does not intersect the median, then it is recorded as not able to be estimated with a dash
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- 4.9
- comment
- The confidence intervals are generated via the Brookmeyer-Crowley method (if a limit of the interval does not intersect the median, then it is recorded as not able to be estimated with a dash
- group Id
- OG001
- lower Limit
- 3.6
- upper Limit
- NA
- value
- 4.8
- title
- Partial Response
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 10
- units
- Participants
- description
- The duration of response after VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) in primary central nervous system lymphoma (PCNSL) and secondary central nervous system lymphoma (SCNSL) will be determined starting at the date a response is identified and will be estimated using a Kaplan-Meier curve along with a median DOR, and its associated 95% confidence interval. The duration of response (DOR) is measured from the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, death, or, in the absence of progressive disease (PD), date of last assessment. CR is disappearance of all detectable evidence of disease and disease-related symptoms. PR is a ≥50% decrease in the sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses. Progression is appearance of any new nodal lesion.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Cohort 1, Arm 1: Participants with primary diffuse large B-cell lymphoma of the central nervous system (CNS) primary central nervous system lymphoma (PCNSL) or secondary CNS lymphoma (SCNSL). Experimental - Nivolumab on Day 1 with lenalidomide (days 1-14) for a 21-day cycle. Following Window, VIPOR-Nivo (venetoclax, ibrutinib, prednisone, Obinutuzumab, lenalidomide, and nivolumab) in 21-day cycles for up to 6 cycles.
- id
- OG000
- title
- Lenalidomide+Nivolumab Followed by Venetoclax, Ibrutinib,Prednisone, Obinutuzumab, Lenalidomide-Nivo
- description
- Participants with primary diffuse large B-cell lymphoma of the central nervous system (CNS) primary central nervous system lymphoma (PCNSL) or secondary CNS lymphoma (SCNSL). VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) in 21-day cycles for up to 6 cycles.
- id
- OG001
- title
- Cohort 1, Arm 2: Experimental- VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide)
- param Type
- MEDIAN
- reporting Status
- POSTED
- time Frame
- From date of first response until the date of recurrent or progressive disease is objectively documented, up to a max 2.6 years
- title
- Duration of Response (DOR)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice