Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03255018 · OUTCOME

Best Overall Response Rate of Pembrolizumab in Participants With Relapsed/Refractory Gray-zone Lymphomas (GZL) and Extra-nodal Diffuse Large B-cell Lymphomas (DLBCL)

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
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
Up to 24 months

What was measured

Response was assessed by the International Working Group (IWG) response criteria which utilizes computed tomography (CT) scan to measure lymph node masses to assess response, bone marrow biopsies and aspirates done only if positive at the time of diagnosis or if clinically indicated. Response is calculated by measuring the sum of the products of all target lesions and then calculating the percent change from baseline or nadir. Products are calculated by multiplying the longest length by the perpendicular width of each target lesion. Confirmed complete response is \<1 cm lymph nodes/lymph node masses; unconfirmed complete response is \>1 cm lymph nodes and \>75% decrease in size of lymph node masses; partial response is ≥50% decrease in size of lymph nodes/lymph node masses; and progression is \>50% new or increased lymph node masses/lymph nodes. Complete response (confirmed) followed by complete response(unconfirmed) and partial response are associated with better outcomes in that order.

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

Complete Response
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1 Gray-Zone Lymphoma (GZL)50Not reportedNot reportedNot reportedNot reported
Cohort 2 Extra-nodal Diffuse Large B-cell Lymphoma (DLBCL)0Not reportedNot reportedNot reportedNot reported
Unconfirmed Complete Response
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1 Gray-Zone Lymphoma (GZL)0Not reportedNot reportedNot reportedNot reported
Cohort 2 Extra-nodal Diffuse Large B-cell Lymphoma (DLBCL)0Not reportedNot reportedNot reportedNot reported
Partial Response
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1 Gray-Zone Lymphoma (GZL)0Not reportedNot reportedNot reportedNot reported
Cohort 2 Extra-nodal Diffuse Large B-cell Lymphoma (DLBCL)11Not reportedNot reportedNot reportedNot reported
Progressive Disease
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1 Gray-Zone Lymphoma (GZL)50Not reportedNot reportedNot reportedNot reported
Cohort 2 Extra-nodal Diffuse Large B-cell Lymphoma (DLBCL)89Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        50
      2. group Id
        OG001
        value
        0
    title
    Complete Response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Unconfirmed Complete Response
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        11
    title
    Partial Response
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        50
      2. group Id
        OG001
        value
        89
    title
    Progressive Disease
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      9
    units
    Participants
description
Response was assessed by the International Working Group (IWG) response criteria which utilizes computed tomography (CT) scan to measure lymph node masses to assess response, bone marrow biopsies and aspirates done only if positive at the time of diagnosis or if clinically indicated. Response is calculated by measuring the sum of the products of all target lesions and then calculating the percent change from baseline or nadir. Products are calculated by multiplying the longest length by the perpendicular width of each target lesion. Confirmed complete response is \<1 cm lymph nodes/lymph node masses; unconfirmed complete response is \>1 cm lymph nodes and \>75% decrease in size of lymph node masses; partial response is ≥50% decrease in size of lymph nodes/lymph node masses; and progression is \>50% new or increased lymph node masses/lymph nodes. Complete response (confirmed) followed by complete response(unconfirmed) and partial response are associated with better outcomes in that order.
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
NUMBER
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
Up to 24 months
title
Best Overall Response Rate of Pembrolizumab in Participants With Relapsed/Refractory Gray-zone Lymphomas (GZL) and Extra-nodal Diffuse Large B-cell Lymphomas (DLBCL)
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice