TriangleNCT05211336 · OUTCOME
Progression Free Survival (PFS)
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
- Up to 2.6 years
What was measured
Progression-free survival (PFS) is defined as the duration of time from the date of study enrollment until time of disease relapse, disease progression, death, or 10 years post-treatment, whichever occurs first. The progression-free survival (PFS) after VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) in primary central nervous system lymphoma (PCNSL) and secondary central nervous system lymphoma (SCNSL) will be estimated using progression or death without progression as events, using a Kaplan-Meier curve. The median will be determined and presented with its associated 95% confidence interval. Progression was measured by the Lugano criteria and is appearance of any new nodal lesion ≥1.6 cm in greatest tumor dimension or ≥1.1 cm in short axis during or after the end of therapy, even if other lesions are decreasing in size.
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
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lenalidomide+Nivolumab Followed by Venetoclax, Ibrutinib,Prednisone, Obinutuzumab, Lenalidomide-Nivo | 8.4 | Not reported | 4.3 | 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) | 3.0 | Not reported | 2.0 | 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. |
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
- 4.3
- upper Limit
- NA
- value
- 8.4
- 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
- 2.0
- upper Limit
- NA
- value
- 3.0
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 10
- units
- Participants
- description
- Progression-free survival (PFS) is defined as the duration of time from the date of study enrollment until time of disease relapse, disease progression, death, or 10 years post-treatment, whichever occurs first. The progression-free survival (PFS) after VIPOR (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Lenalidomide) in primary central nervous system lymphoma (PCNSL) and secondary central nervous system lymphoma (SCNSL) will be estimated using progression or death without progression as events, using a Kaplan-Meier curve. The median will be determined and presented with its associated 95% confidence interval. Progression was measured by the Lugano criteria and is appearance of any new nodal lesion ≥1.6 cm in greatest tumor dimension or ≥1.1 cm in short axis during or after the end of therapy, even if other lesions are decreasing in size.
- 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
- Up to 2.6 years
- title
- Progression Free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice