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NCT03255018 · OUTCOME

Overall Survival (OS)

Pembrolizumab in Relapsed and Refractory Gray-Zone Lymphoma (GZL), Primary Central Nervous System Lymphoma (PCNSL), and Other Extranodal Diffuse Large B-cell Lymphomas · Source last updated 2023-11-28

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
every 3-6 months, up to 2.5 years

What was measured

OS is the time from treatment start date until date of death from any cause, date last known alive or last follow up. OS will be estimated for each of the two types of lymphoma individually using Kaplan-Meier curves with appropriate confidence intervals reported.

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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Cohort 1 Gray-Zone Lymphoma (GZL)2
Cohort 2 Extra-nodal Diffuse Large B-cell Lymphoma (DLBCL)9

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort 1 Gray-Zone Lymphoma (GZL)NANot reportedNANAMedian OS was not reached due to more than 50% of participants still being alive.
Cohort 2 Extra-nodal Diffuse Large B-cell Lymphoma (DLBCL)28.8Not reported1.1NAThe upper confidence interval (CI) is not estimable. The upper CI is not estimable when there are insufficient (or no) events past the time reported to calculate the upper CI limit. It is mathematically not possible to determine the upper limit in those cases.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Median OS was not reached due to more than 50% of participants still being alive.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        The upper confidence interval (CI) is not estimable. The upper CI is not estimable when there are insufficient (or no) events past the time reported to calculate the upper CI limit. It is mathematically not possible to determine the upper limit in those cases.
        group Id
        OG001
        lower Limit
        1.1
        upper Limit
        NA
        value
        28.8
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      9
    units
    Participants
description
OS is the time from treatment start date until date of death from any cause, date last known alive or last follow up. OS will be estimated for each of the two types of lymphoma individually using Kaplan-Meier curves with appropriate confidence intervals reported.
dispersion Type
95% Confidence Interval
groups
  1. 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)
  2. 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, up to 2.5 years
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
Months

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice