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NCT01492088 · OUTCOME

Number of Participants With Antitherapeutic Antibodies (ATA) and Neutralizing ATA (nATA) (Phase 1 and 2)

Study of Brentuximab Vedotin (SGN-35) in Pediatric Participants With Relapsed or Refractory (r/r) Systemic Anaplastic Large-Cell Lymphoma or Hodgkin Lymphoma · Source last updated 2024-05-30

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
Baseline up to EOT (Up to 15 months)

What was measured

Blood samples were collected to assess the immunogenicity of brentuximab vedotin (ATA and nATA development) using a laboratory test. ATA-positive samples were further characterized as transiently ATA positive (defined as 1 or 2 post-Baseline ATA-positive responses), persistently ATA positive (defined as more than 2 post-Baseline ATA positive responses), and nATA positive or negative.

Analysis population: Participants from the Safety Population, all enrolled participants who received at least one dose of brentuximab vedotin, with data available for analysis.

Groups in this outcome

Brentuximab Vedotin 1.4 mg/kg: Phase 1

Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.

Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only

Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.

Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only

Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.

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

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin 1.4 mg/kg: Phase 13
Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only16
Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only17

Reported measurements

ATA status: Transiently positive
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin 1.4 mg/kg: Phase 11Not reportedNot reportedNot reportedNot reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only4Not reportedNot reportedNot reportedNot reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only7Not reportedNot reportedNot reportedNot reported
ATA status: Persistently positive
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin 1.4 mg/kg: Phase 10Not reportedNot reportedNot reportedNot reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only2Not reportedNot reportedNot reportedNot reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only0Not reportedNot reportedNot reportedNot reported
nATA status: Positive
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin 1.4 mg/kg: Phase 10Not reportedNot reportedNot reportedNot reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only5Not reportedNot reportedNot reportedNot reported
Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        7
    title
    ATA status: Transiently positive
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        0
    title
    ATA status: Persistently positive
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        4
    title
    nATA status: Positive
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      16
    3. group Id
      OG002
      value
      17
    units
    Participants
description
Blood samples were collected to assess the immunogenicity of brentuximab vedotin (ATA and nATA development) using a laboratory test. ATA-positive samples were further characterized as transiently ATA positive (defined as 1 or 2 post-Baseline ATA-positive responses), persistently ATA positive (defined as more than 2 post-Baseline ATA positive responses), and nATA positive or negative.
groups
  1. description
    Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
    id
    OG000
    title
    Brentuximab Vedotin 1.4 mg/kg: Phase 1
  2. description
    Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
    id
    OG001
    title
    Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only
  3. description
    Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
    id
    OG002
    title
    Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only
param Type
COUNT_OF_PARTICIPANTS
population Description
Participants from the Safety Population, all enrolled participants who received at least one dose of brentuximab vedotin, with data available for analysis.
reporting Status
POSTED
time Frame
Baseline up to EOT (Up to 15 months)
title
Number of Participants With Antitherapeutic Antibodies (ATA) and Neutralizing ATA (nATA) (Phase 1 and 2)
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice