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NCT01578499 · OUTCOME

Number of Participants With Antitherapeutic Antibodies (ATA) to Brentuximab Vedotin

A Phase 3 Trial of Brentuximab Vedotin(SGN-35) Versus Physician's Choice (Methotrexate or Bexarotene) in Participants With CD30-Positive Cutaneous T-Cell Lymphoma (ALCANZA Study) · Source last updated 2021-01-05

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Baseline up to End of Treatment (Week 52)

What was measured

Blood was collected and evaluated for ATA and neutralizing ATA in all participants who received brentuximab vedotin to assess immunogenicity.

Analysis population: The Safety population included participants who received at least one dose of study drug.

Groups in this outcome

pcALCL: Brentuximab Vedotin

Participants with pcALCL received brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).

MF: Brentuximab Vedotin 1.8 mg/kg

Participants with MF received brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).

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

Analysis denominator · Participants

GroupSource count
pcALCL: Brentuximab Vedotin16
MF: Brentuximab Vedotin 1.8 mg/kg50

Reported measurements

Immunogenicity-evaluable participants
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
pcALCL: Brentuximab Vedotin14Not reportedNot reportedNot reportedNot reported
MF: Brentuximab Vedotin 1.8 mg/kg46Not reportedNot reportedNot reportedNot reported
Baseline Negative: ATA negative
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
pcALCL: Brentuximab Vedotin8Not reportedNot reportedNot reportedNot reported
MF: Brentuximab Vedotin 1.8 mg/kg23Not reportedNot reportedNot reportedNot reported
Baseline Negative: ATA positive
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
pcALCL: Brentuximab Vedotin6Not reportedNot reportedNot reportedNot reported
MF: Brentuximab Vedotin 1.8 mg/kg19Not reportedNot reportedNot reportedNot reported
Baseline Negative: Transiently Positive
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
pcALCL: Brentuximab Vedotin4Not reportedNot reportedNot reportedNot reported
MF: Brentuximab Vedotin 1.8 mg/kg9Not reportedNot reportedNot reportedNot reported
Baseline Negative: Persistently Positive
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
pcALCL: Brentuximab Vedotin2Not reportedNot reportedNot reportedNot reported
MF: Brentuximab Vedotin 1.8 mg/kg10Not reportedNot reportedNot reportedNot reported
Baseline Negative: Neutralizing ATA Positive
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
pcALCL: Brentuximab Vedotin4Not reportedNot reportedNot reportedNot reported
MF: Brentuximab Vedotin 1.8 mg/kg14Not reportedNot reportedNot reportedNot reported
Baseline Positive: ATA Negative
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
pcALCL: Brentuximab Vedotin0Not reportedNot reportedNot reportedNot reported
MF: Brentuximab Vedotin 1.8 mg/kg1Not reportedNot reportedNot reportedNot reported
Baseline Positive: ATA Positive
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
pcALCL: Brentuximab Vedotin0Not reportedNot reportedNot reportedNot reported
MF: Brentuximab Vedotin 1.8 mg/kg3Not reportedNot reportedNot reportedNot reported
Baseline Positive: Transiently Positive
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
pcALCL: Brentuximab Vedotin0Not reportedNot reportedNot reportedNot reported
MF: Brentuximab Vedotin 1.8 mg/kg3Not reportedNot reportedNot reportedNot reported
Baseline Positive: Persistently Positive
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
pcALCL: Brentuximab Vedotin0Not reportedNot reportedNot reportedNot reported
MF: Brentuximab Vedotin 1.8 mg/kg0Not reportedNot reportedNot reportedNot reported
Baseline Positive: Neutralizing ATA Positive
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
pcALCL: Brentuximab Vedotin0Not reportedNot reportedNot reportedNot reported
MF: Brentuximab Vedotin 1.8 mg/kg2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        14
      2. group Id
        OG001
        value
        46
    title
    Immunogenicity-evaluable participants
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        23
    title
    Baseline Negative: ATA negative
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        19
    title
    Baseline Negative: ATA positive
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        9
    title
    Baseline Negative: Transiently Positive
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        10
    title
    Baseline Negative: Persistently Positive
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        14
    title
    Baseline Negative: Neutralizing ATA Positive
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Baseline Positive: ATA Negative
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        3
    title
    Baseline Positive: ATA Positive
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        3
    title
    Baseline Positive: Transiently Positive
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Baseline Positive: Persistently Positive
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
    title
    Baseline Positive: Neutralizing ATA Positive
denoms
  1. counts
    1. group Id
      OG000
      value
      16
    2. group Id
      OG001
      value
      50
    units
    Participants
description
Blood was collected and evaluated for ATA and neutralizing ATA in all participants who received brentuximab vedotin to assess immunogenicity.
groups
  1. description
    Participants with pcALCL received brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
    id
    OG000
    title
    pcALCL: Brentuximab Vedotin
  2. description
    Participants with MF received brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
    id
    OG001
    title
    MF: Brentuximab Vedotin 1.8 mg/kg
param Type
NUMBER
population Description
The Safety population included participants who received at least one dose of study drug.
reporting Status
POSTED
time Frame
Baseline up to End of Treatment (Week 52)
title
Number of Participants With Antitherapeutic Antibodies (ATA) to Brentuximab Vedotin
type
SECONDARY
unit Of Measure
participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice