TriangleNCT01953692 · OUTCOME
Progression-free Survival (PFS) in Participants Pooled From the Cohort 5 (Pembrolizumab + 20 or 25 mg Doses of Lenalidomide) Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL)
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 approximately 78.5 months
What was measured
PFS was defined as the time from first dose of study treatment to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. PD was assessed according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. PD was the appearance of any new lesion, \>50% increase in the sum of product diameters (SPD) of ≥1 lymph node, or a \>50% increase in the longest diameter of a previous lymph node, lesions positron emission tomography (PET) positive if 18F-fluorodeoxyglucose (FDG)-avid lymphoma or PET positive prior to therapy for lymph nodes; \>50% increase from nadir in the SPD of previous lesions in the liver and spleen; or new or recurrent involvement of the bone marrow. PFS was calculated from the Kaplan-Meier method for censored data. PFS as assessed by the investigator is presented.
Analysis population: All participants pooled from Cohort 5 (pembrolizumab + 20 or 25 mg doses of lenalidomide) with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation. The analysis was pre-specified to be a pooled analysis of all participants grouped by disease cohort (DLBCL) and treatment combination (irrespective of dose); therefore data by individual dose were not analyzed.
Groups in this outcome
Pooled Cohort 5 (Pembrolizumab + 20 or 25 mg Doses of Lenalidomide)
Participants from the pooled Cohort 5 received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle + lenalidomide 20 mg or 25 mg PO QD for 21 consecutive days with 7 days off within 28-day cycles.
| Group | Source count |
|---|---|
| Pooled Cohort 5 (Pembrolizumab + 20 or 25 mg Doses of Lenalidomide) | 18 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pooled Cohort 5 (Pembrolizumab + 20 or 25 mg Doses of Lenalidomide) | 5.5 | Not reported | 2.7 | NA | NA=PFS upper limit not reached at time of data cut-off due to insufficient number of participants with an event. |
Complete source fields
- classes
- categories
- measurements
- comment
- NA=PFS upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
- group Id
- OG000
- lower Limit
- 2.7
- upper Limit
- NA
- value
- 5.5
- denoms
- counts
- group Id
- OG000
- value
- 18
- units
- Participants
- description
- PFS was defined as the time from first dose of study treatment to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. PD was assessed according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. PD was the appearance of any new lesion, \>50% increase in the sum of product diameters (SPD) of ≥1 lymph node, or a \>50% increase in the longest diameter of a previous lymph node, lesions positron emission tomography (PET) positive if 18F-fluorodeoxyglucose (FDG)-avid lymphoma or PET positive prior to therapy for lymph nodes; \>50% increase from nadir in the SPD of previous lesions in the liver and spleen; or new or recurrent involvement of the bone marrow. PFS was calculated from the Kaplan-Meier method for censored data. PFS as assessed by the investigator is presented.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants from the pooled Cohort 5 received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle + lenalidomide 20 mg or 25 mg PO QD for 21 consecutive days with 7 days off within 28-day cycles.
- id
- OG000
- title
- Pooled Cohort 5 (Pembrolizumab + 20 or 25 mg Doses of Lenalidomide)
- param Type
- MEDIAN
- population Description
- All participants pooled from Cohort 5 (pembrolizumab + 20 or 25 mg doses of lenalidomide) with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation. The analysis was pre-specified to be a pooled analysis of all participants grouped by disease cohort (DLBCL) and treatment combination (irrespective of dose); therefore data by individual dose were not analyzed.
- reporting Status
- POSTED
- time Frame
- Up to approximately 78.5 months
- title
- Progression-free Survival (PFS) in Participants Pooled From the Cohort 5 (Pembrolizumab + 20 or 25 mg Doses of Lenalidomide) Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice