TriangleNCT01953692 · OUTCOME
Duration of Response (DOR) in the Cohort 4 Non-Hodgkin Lymphoma (NHL) Individual Sub-Cohorts (Cohorts 4A, 4B, 4C, and 4D)
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
DOR was evaluated for each of the Cohort 4 sub-cohorts: 4A (primary mediastinal B-cell lymphoma), 4B (grey zone, splenic marginal zone, and mantle cell lymphomas), 4C (follicular lymphoma), and 4D (diffuse large B-Cell lymphoma). 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 in Cohorts 4A, 4B, 4C, and 4D with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation and who demonstrated a PR or CR.
Groups in this outcome
Cohort 4A: R/R Primary Mediastinal B-cell Lymphoma (PMBCL)
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
Cohort 4B: Other Non-Hodgkin Lymphoma: Grey Zone, Splenic Marginal Zone, and Mantle Cell Lymphomas
Participants received pembrolizumab 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
Cohort 4C: R/R Follicular Lymphoma (FL)
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle.
Cohort 4D: R/R Diffuse Large B-Cell Lymphoma (DLBCL)
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle.
| Group | Source count |
|---|---|
| Cohort 4A: R/R Primary Mediastinal B-cell Lymphoma (PMBCL) | 10 |
| Cohort 4B: Other Non-Hodgkin Lymphoma: Grey Zone, Splenic Marginal Zone, and Mantle Cell Lymphomas | 2 |
| Cohort 4C: R/R Follicular Lymphoma (FL) | 2 |
| Cohort 4D: R/R Diffuse Large B-Cell Lymphoma (DLBCL) | 5 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 4A: R/R Primary Mediastinal B-cell Lymphoma (PMBCL) | NA | Not reported | 6.9 | NA | NA=Median DOR and upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse. |
| Cohort 4B: Other Non-Hodgkin Lymphoma: Grey Zone, Splenic Marginal Zone, and Mantle Cell Lymphomas | NA | Not reported | 1.7 | NA | NA=Median DOR and upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse. |
| Cohort 4C: R/R Follicular Lymphoma (FL) | NA | Not reported | NA | NA | NA=Median DOR and upper and lower limits not reached at time of data cut-off due to insufficient number of responding participants with relapse. |
| Cohort 4D: R/R Diffuse Large B-Cell Lymphoma (DLBCL) | 13.6 | Not reported | 2.6 | NA | NA=DOR 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
- 6.9
- upper Limit
- NA
- value
- NA
- 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
- OG001
- lower Limit
- 1.7
- upper Limit
- NA
- value
- NA
- comment
- NA=Median DOR and upper and lower limits not reached at time of data cut-off due to insufficient number of responding participants with relapse.
- group Id
- OG002
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- NA=DOR upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
- group Id
- OG003
- lower Limit
- 2.6
- upper Limit
- NA
- value
- 13.6
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 5
- units
- Participants
- description
- DOR was evaluated for each of the Cohort 4 sub-cohorts: 4A (primary mediastinal B-cell lymphoma), 4B (grey zone, splenic marginal zone, and mantle cell lymphomas), 4C (follicular lymphoma), and 4D (diffuse large B-Cell lymphoma). 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 received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
- id
- OG000
- title
- Cohort 4A: R/R Primary Mediastinal B-cell Lymphoma (PMBCL)
- description
- Participants received pembrolizumab 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
- id
- OG001
- title
- Cohort 4B: Other Non-Hodgkin Lymphoma: Grey Zone, Splenic Marginal Zone, and Mantle Cell Lymphomas
- description
- Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle.
- id
- OG002
- title
- Cohort 4C: R/R Follicular Lymphoma (FL)
- description
- Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle.
- id
- OG003
- title
- Cohort 4D: R/R Diffuse Large B-Cell Lymphoma (DLBCL)
- param Type
- MEDIAN
- population Description
- All participants in Cohorts 4A, 4B, 4C, and 4D with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation and who demonstrated a PR or CR.
- reporting Status
- POSTED
- time Frame
- Up to approximately 78.5 months
- title
- Duration of Response (DOR) in the Cohort 4 Non-Hodgkin Lymphoma (NHL) Individual Sub-Cohorts (Cohorts 4A, 4B, 4C, and 4D)
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice