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NCT04213209 · OUTCOME

Percentage of Participants Who Achieve or Maintain Any Best Response for Adult Participants With PTCL-NOS, AITL, the Other PTCL, and Pediatric Participants With PTCL

Special Drug Use Surveillance for Brentuximab Vedotin Intravenous Infusion "Relapsed or Refractory CD30-positive Peripheral T Cell Lymphoma or Pediatric Hodgkin Lymphoma" · Source last updated 2024-09-27

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to 12 Months

What was measured

Best response is defined as the cumulative numbers of participants who achieve each level of best response including complete response (CR), complete response uncertain (CRu) (when no positron emission tomography \[PET\] data are available), partial response (PR), Stable Disease (SD), and Progressive Disease (PD) after treatment. Best response was assessed by the antitumor response criteria for adult PTCL. Reported data are divided into 2 populations; with or without PET data for each group. PET was used in cancer diagnosis and treatment.

Analysis population: Efficacy analysis set: all participants who received at least one dose of protocol treatment without major protocol deviation. The number analyzed was the number of participants with data available for analysis.

Groups in this outcome

Adult Participants With PTCL-NOS

Adult participants with peripheral T-cell lymphoma not otherwise specified (PTCL-NOS) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care.

Adult Participants With AITL

Adult participants with angioimmunoblastic T-cell lymphoma (AITL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care.

Adult Participants With Other PTCL

Adult participants with the other PTCL (peripheral T-cell lymphoma \[PTCL\] subtypes other than anaplastic large-cell lymphoma \[ALCL\] \[not surveyed\], PTCL-NOS, AITL, and ATLL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care.

Pediatric Participants With PTCL

Pediatric participants with peripheral T-cell lymphoma (PTCL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care.

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

Analysis denominator · Participants

GroupSource count
Adult Participants With PTCL-NOS24
Adult Participants With AITL27
Adult Participants With Other PTCL3
Pediatric Participants With PTCL1

Reported measurements

With PET Assessment

Analysis denominator · Participants

GroupSource count
Adult Participants With PTCL-NOS9
Adult Participants With AITL14
Adult Participants With Other PTCL1
Pediatric Participants With PTCL1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Adult Participants With PTCL-NOS7Not reportedNot reportedNot reportedNot reported
Adult Participants With AITL12Not reportedNot reportedNot reportedNot reported
Adult Participants With Other PTCL0Not reportedNot reportedNot reportedNot reported
Pediatric Participants With PTCL1Not reportedNot reportedNot reportedNot reported
Without PET Assessment

Analysis denominator · Participants

GroupSource count
Adult Participants With PTCL-NOS15
Adult Participants With AITL13
Adult Participants With Other PTCL2
Pediatric Participants With PTCL0
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Adult Participants With PTCL-NOS4Not reportedNot reportedNot reportedNot reported
Adult Participants With AITL5Not reportedNot reportedNot reportedNot reported
Adult Participants With Other PTCL0Not reportedNot reportedNot reportedNot reported
Pediatric Participants With PTCL0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        12
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        1
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        14
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        1
      units
      Participants
    title
    With PET Assessment
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        13
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        0
      units
      Participants
    title
    Without PET Assessment
denoms
  1. counts
    1. group Id
      OG000
      value
      24
    2. group Id
      OG001
      value
      27
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      1
    units
    Participants
description
Best response is defined as the cumulative numbers of participants who achieve each level of best response including complete response (CR), complete response uncertain (CRu) (when no positron emission tomography \[PET\] data are available), partial response (PR), Stable Disease (SD), and Progressive Disease (PD) after treatment. Best response was assessed by the antitumor response criteria for adult PTCL. Reported data are divided into 2 populations; with or without PET data for each group. PET was used in cancer diagnosis and treatment.
groups
  1. description
    Adult participants with peripheral T-cell lymphoma not otherwise specified (PTCL-NOS) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care.
    id
    OG000
    title
    Adult Participants With PTCL-NOS
  2. description
    Adult participants with angioimmunoblastic T-cell lymphoma (AITL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care.
    id
    OG001
    title
    Adult Participants With AITL
  3. description
    Adult participants with the other PTCL (peripheral T-cell lymphoma \[PTCL\] subtypes other than anaplastic large-cell lymphoma \[ALCL\] \[not surveyed\], PTCL-NOS, AITL, and ATLL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care.
    id
    OG002
    title
    Adult Participants With Other PTCL
  4. description
    Pediatric participants with peripheral T-cell lymphoma (PTCL) were received brentuximab vedotin (genetic recombination) 1.8 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every three weeks (up to 12 months). The dose should be reduced appropriately depend on the participant's condition. Participants received interventions as part of routine medical care.
    id
    OG003
    title
    Pediatric Participants With PTCL
param Type
COUNT_OF_PARTICIPANTS
population Description
Efficacy analysis set: all participants who received at least one dose of protocol treatment without major protocol deviation. The number analyzed was the number of participants with data available for analysis.
reporting Status
POSTED
time Frame
Up to 12 Months
title
Percentage of Participants Who Achieve or Maintain Any Best Response for Adult Participants With PTCL-NOS, AITL, the Other PTCL, and Pediatric Participants With PTCL
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice