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NCT03255018 · OUTCOME

Best Overall Response Rate According to the 5-point Lugano Classification for Interpreting 18 F-fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET) Scans

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
every 3-6 months for 24 months

What was measured

The response rate is calculated by dividing the number of participants that had a complete response (CR) or partial response (PR) to therapy measured on positron emission tomography (PET) scan in accordance with the 5-point Lugano classification. Best overall response is the best response (complete or partial response) recorded from the start of the treatment until disease progression/recurrence. The 5-Point Scale Deauville criteria scores the most intense uptake in a site of initial disease: no uptake or no residual uptake, slight uptake, but above blood pool, uptake above mediastinal but below or =to uptake in liver, uptake slightly to moderately higher than liver, \& markedly increased uptake. 5Point Scale ranges:1 to 5, 1=best; 5=worst: 1, no uptake above background; 2, uptake ≤ mediastinum; 3, uptake \> mediastinum but ≤ liver; 4, uptake moderately \> liver; 5, uptake markedly higher than liver; X. CR=scores 1-3 on \& PR is calculated by measured change from baseline (score 4 or 5).

Analysis population: For this outcome only 1 out of the 2 participants in the GZL cohort had a PET scan at the time of best response. In the DLBCL cohort only 6 out of the 9 had a PET Scan at the time of best response.

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)1
Cohort 2 Extra-nodal Diffuse Large B-cell Lymphoma (DLBCL)6

Reported measurements

Complete Response
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1 Gray-Zone Lymphoma (GZL)100Not 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)0Not reportedNot reportedNot reportedNot reported
Stable Disease
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
Progressive Disease
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)100Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        100
      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
    Partial Response
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Stable Disease
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        100
    title
    Progressive Disease
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      6
    units
    Participants
description
The response rate is calculated by dividing the number of participants that had a complete response (CR) or partial response (PR) to therapy measured on positron emission tomography (PET) scan in accordance with the 5-point Lugano classification. Best overall response is the best response (complete or partial response) recorded from the start of the treatment until disease progression/recurrence. The 5-Point Scale Deauville criteria scores the most intense uptake in a site of initial disease: no uptake or no residual uptake, slight uptake, but above blood pool, uptake above mediastinal but below or =to uptake in liver, uptake slightly to moderately higher than liver, \& markedly increased uptake. 5Point Scale ranges:1 to 5, 1=best; 5=worst: 1, no uptake above background; 2, uptake ≤ mediastinum; 3, uptake \> mediastinum but ≤ liver; 4, uptake moderately \> liver; 5, uptake markedly higher than liver; X. CR=scores 1-3 on \& PR is calculated by measured change from baseline (score 4 or 5).
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
For this outcome only 1 out of the 2 participants in the GZL cohort had a PET scan at the time of best response. In the DLBCL cohort only 6 out of the 9 had a PET Scan at the time of best response.
reporting Status
POSTED
time Frame
every 3-6 months for 24 months
title
Best Overall Response Rate According to the 5-point Lugano Classification for Interpreting 18 F-fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET) Scans
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice