TriangleNCT03255018 · OUTCOME
Event-free Survival (EFS)
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 months
What was measured
EFS is defined as the duration of time from the date of study enrollment until time of disease relapse, disease progression, alternative therapy for lymphoma given (such as radiation), or death, whichever occurs first. EFS will be estimated for each of the two types of lymphoma individually using Kaplan-Meier curves with appropriate confidence intervals reported. Response was assessed by the International Working Group response criteria (Cheson et al.). Disease relapse is decline in prognosis and progression \>50% increase in lymph node masses/lymph nodes, enlarging liver/spleen, new sites and reappearance in bone marrow.
Analysis population: 1 participant in the GZL cohort, and 1 participant enrolled in the DLBCL cohort 1 were not evaluable due to withdrawal of consent prior to treatment.
Groups in this outcome
Cohort 1 Gray-Zone Lymphoma (GZL)
Cohort 1: B-cell lymphoma, unclassifiable, with features intermediate between diffuse large B-cell lymphoma and classical Hodgkin lymphoma (i.e., Gray-zone lymphoma or GZL) Participants will be treated with pembrolizumab 200 mg (flat dose) intravenous (IV) every 3 weeks provided they have clinical benefit and no unacceptable toxicity; participants who achieve a complete response (CR) will have the option to stop after 1 year of therapy.
Cohort 2 Extra-nodal Diffuse Large B-cell Lymphoma (DLBCL)
Cohort 2: Extra-nodal diffuse large B-cell lymphoma involving one or more of the specified extra-nodal sites (i.e., extra-nodal DLBCL) Participants will be treated with pembrolizumab 200 mg (flat dose) intravenous (IV) every 3 weeks provided they have clinical benefit and no unacceptable toxicity; participants who achieve a complete response (CR) will have the option to stop after 1 year of therapy.
| Group | Source count |
|---|---|
| Cohort 1 Gray-Zone Lymphoma (GZL) | 2 |
| Cohort 2 Extra-nodal Diffuse Large B-cell Lymphoma (DLBCL) | 9 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 Gray-Zone Lymphoma (GZL) | NA | Not reported | NA | NA | Median EFS not reached due to more than 50% of participants in the GZL cohort not experiencing a progression event. |
| Cohort 2 Extra-nodal Diffuse Large B-cell Lymphoma (DLBCL) | 1.4 | Not reported | 0.5 | 2.3 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- Median EFS not reached due to more than 50% of participants in the GZL cohort not experiencing a progression event.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- group Id
- OG001
- lower Limit
- 0.5
- upper Limit
- 2.3
- value
- 1.4
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 9
- units
- Participants
- description
- EFS is defined as the duration of time from the date of study enrollment until time of disease relapse, disease progression, alternative therapy for lymphoma given (such as radiation), or death, whichever occurs first. EFS will be estimated for each of the two types of lymphoma individually using Kaplan-Meier curves with appropriate confidence intervals reported. Response was assessed by the International Working Group response criteria (Cheson et al.). Disease relapse is decline in prognosis and progression \>50% increase in lymph node masses/lymph nodes, enlarging liver/spleen, new sites and reappearance in bone marrow.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Cohort 1: B-cell lymphoma, unclassifiable, with features intermediate between diffuse large B-cell lymphoma and classical Hodgkin lymphoma (i.e., Gray-zone lymphoma or GZL) Participants will be treated with pembrolizumab 200 mg (flat dose) intravenous (IV) every 3 weeks provided they have clinical benefit and no unacceptable toxicity; participants who achieve a complete response (CR) will have the option to stop after 1 year of therapy.
- id
- OG000
- title
- Cohort 1 Gray-Zone Lymphoma (GZL)
- description
- Cohort 2: Extra-nodal diffuse large B-cell lymphoma involving one or more of the specified extra-nodal sites (i.e., extra-nodal DLBCL) Participants will be treated with pembrolizumab 200 mg (flat dose) intravenous (IV) every 3 weeks provided they have clinical benefit and no unacceptable toxicity; participants who achieve a complete response (CR) will have the option to stop after 1 year of therapy.
- id
- OG001
- title
- Cohort 2 Extra-nodal Diffuse Large B-cell Lymphoma (DLBCL)
- param Type
- MEDIAN
- population Description
- 1 participant in the GZL cohort, and 1 participant enrolled in the DLBCL cohort 1 were not evaluable due to withdrawal of consent prior to treatment.
- reporting Status
- POSTED
- time Frame
- up to 2 months
- title
- Event-free Survival (EFS)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice