TriangleNCT03255018 · OUTCOME
Duration of Response for Participants Who Respond to Pembrolizumab
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- Full Range
- Time frame
- every 3-6 months for 24 months
What was measured
DOR is beginning at the date clinical response is first identified; measured from the time measurement criteria are met for complete response or partial response (whichever is first recorded) until the first date that recurrent or progressive disease is documented and 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.). Complete response is \<1 cm lymph nodes/lymph node masses, and normal bone marrow/physical exam (PE); unconfirmed complete response is \>1 cm lymph nodes and \>75% decrease lymph node masses, normal PE and indeterminate in bone marrow; partial response is ≥50% decrease in lymph nodes/lymph node masses, decrease in liver/spleen and irrelevant in bone marrow; and progression is \>50% new or increased lymph node masses/lymph nodes, enlarging liver/spleen, and reappearance in bone marrow.
Analysis population: 9/10 participants are analyzed in the DLBCL cohort because 1 participant was 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) | 18.25 | Not reported | 0 | 36.5 | Not reported |
| Cohort 2 Extra-nodal Diffuse Large B-cell Lymphoma (DLBCL) | 0.9 | Not reported | 0 | 0.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 36.5
- value
- 18.25
- group Id
- OG001
- lower Limit
- 0
- upper Limit
- 0.9
- value
- 0.9
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 9
- units
- Participants
- description
- DOR is beginning at the date clinical response is first identified; measured from the time measurement criteria are met for complete response or partial response (whichever is first recorded) until the first date that recurrent or progressive disease is documented and 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.). Complete response is \<1 cm lymph nodes/lymph node masses, and normal bone marrow/physical exam (PE); unconfirmed complete response is \>1 cm lymph nodes and \>75% decrease lymph node masses, normal PE and indeterminate in bone marrow; partial response is ≥50% decrease in lymph nodes/lymph node masses, decrease in liver/spleen and irrelevant in bone marrow; and progression is \>50% new or increased lymph node masses/lymph nodes, enlarging liver/spleen, and reappearance in bone marrow.
- dispersion Type
- Full Range
- 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
- 9/10 participants are analyzed in the DLBCL cohort because 1 participant was not evaluable due to withdrawal of consent prior to treatment.
- reporting Status
- POSTED
- time Frame
- every 3-6 months for 24 months
- title
- Duration of Response for Participants Who Respond to Pembrolizumab
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice