TriangleNCT01953692 · OUTCOME
Progression-free Survival (PFS) 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
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 in Cohorts 4A, 4B, 4C, and 4D with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation.
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 intravenous (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) | 21 |
| Cohort 4B: Other Non-Hodgkin Lymphoma: Grey Zone, Splenic Marginal Zone, and Mantle Cell Lymphomas | 4 |
| Cohort 4C: R/R Follicular Lymphoma (FL) | 20 |
| Cohort 4D: R/R Diffuse Large B-Cell Lymphoma (DLBCL) | 41 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 4A: R/R Primary Mediastinal B-cell Lymphoma (PMBCL) | 19.0 | Not reported | 1.9 | NA | NA=PFS upper limit not reached at time of data cut-off due to insufficient number of participants with an event. |
| Cohort 4B: Other Non-Hodgkin Lymphoma: Grey Zone, Splenic Marginal Zone, and Mantle Cell Lymphomas | 7.3 | Not reported | 0.3 | 10.3 | Not reported |
| Cohort 4C: R/R Follicular Lymphoma (FL) | 1.7 | Not reported | 1.3 | 3.4 | Not reported |
| Cohort 4D: R/R Diffuse Large B-Cell Lymphoma (DLBCL) | 1.4 | Not reported | 1.3 | 1.7 | Not reported |
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
- 1.9
- upper Limit
- NA
- value
- 19.0
- group Id
- OG001
- lower Limit
- 0.3
- upper Limit
- 10.3
- value
- 7.3
- group Id
- OG002
- lower Limit
- 1.3
- upper Limit
- 3.4
- value
- 1.7
- group Id
- OG003
- lower Limit
- 1.3
- upper Limit
- 1.7
- value
- 1.4
- denoms
- counts
- group Id
- OG000
- value
- 21
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 20
- group Id
- OG003
- value
- 41
- 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 received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by intravenous (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.
- reporting Status
- POSTED
- time Frame
- Up to approximately 78.5 months
- title
- Progression-free Survival (PFS) 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