TriangleNCT01953692 · OUTCOME
Duration of Response (DOR) in Participants Pooled From 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
For participants who demonstrated a confirmed Complete Response (CR) or partial response (PR), DOR was defined as the time from CR or PR to documented disease progression or death. CR and PR were assessed according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. CR was demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and lymph nodes. PR was \>50% decrease in the sum of product diameters (SPD) for ≤6 target masses for lymph nodes and \>50% decrease in SPD for a single nodule in greatest transverse diameter for spleen and liver, and no size increase in the lymph nodes, spleen, or liver. DOR as assessed by the investigator is presented.
Analysis population: All participants pooled from the Cohort 5 (pembrolizumab + 20 or 25 mg doses of lenalidomide) with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation and who demonstrated a PR or CR. 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) | 7 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pooled Cohort 5 (Pembrolizumab + 20 or 25 mg Doses of Lenalidomide) | NA | Not reported | 2.8 | NA | NA=Median DOR and upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse. |
Complete source fields
- classes
- categories
- measurements
- comment
- NA=Median DOR and upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
- group Id
- OG000
- lower Limit
- 2.8
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 7
- units
- Participants
- description
- For participants who demonstrated a confirmed Complete Response (CR) or partial response (PR), DOR was defined as the time from CR or PR to documented disease progression or death. CR and PR were assessed according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. CR was demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and lymph nodes. PR was \>50% decrease in the sum of product diameters (SPD) for ≤6 target masses for lymph nodes and \>50% decrease in SPD for a single nodule in greatest transverse diameter for spleen and liver, and no size increase in the lymph nodes, spleen, or liver. DOR 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 the Cohort 5 (pembrolizumab + 20 or 25 mg doses of lenalidomide) with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation and who demonstrated a PR or CR. 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
- Duration of Response (DOR) in Participants Pooled From 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
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Preserved source evidence · Not medical advice