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NCT01578499 · OUTCOME

Percentage of Participants Achieving a CR

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
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Each Cycle until disease progression, death or data cutoff (Median overall follow-up 38.8 months)

What was measured

Complete Response (CR) was determined by the IRF based on Global Response Score (GRS) which consisted of a skin assessment by the investigator using the modified severity-weighted assessment tool (mSWAT), nodal and visceral radiographic and for the participants with mycosis fungoides (MF) only, detection of circulation Sezary cells. Response Criteria was based on ISCL, USCLC and CLTF of the EORTC Consensus guidelines (Olsen, 2011).

Analysis population: The ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment.

Groups in this outcome

Brentuximab Vedotin

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).

Methotrexate or Bexarotene

Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m\^2, tablets, orally, once daily with meals for up to 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
Brentuximab Vedotin64
Methotrexate or Bexarotene64

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin17.2Not reported7.926.4Not reported
Methotrexate or Bexarotene1.6Not reported0.08.4Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    -2.5
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    33.0
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0002
    p Value Comment
    P-value was stratified by baseline disease diagnosis (pcALCL and MF).
    param Type
    Risk Difference (RD)
    param Value
    15.6
    statistical Method
    Cochran-Mantel-Haenszel
Complete source fields
analyses
  1. ci Lower Limit
    -2.5
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    33.0
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0002
    p Value Comment
    P-value was stratified by baseline disease diagnosis (pcALCL and MF).
    param Type
    Risk Difference (RD)
    param Value
    15.6
    statistical Method
    Cochran-Mantel-Haenszel
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.9
        upper Limit
        26.4
        value
        17.2
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        8.4
        value
        1.6
denoms
  1. counts
    1. group Id
      OG000
      value
      64
    2. group Id
      OG001
      value
      64
    units
    Participants
description
Complete Response (CR) was determined by the IRF based on Global Response Score (GRS) which consisted of a skin assessment by the investigator using the modified severity-weighted assessment tool (mSWAT), nodal and visceral radiographic and for the participants with mycosis fungoides (MF) only, detection of circulation Sezary cells. Response Criteria was based on ISCL, USCLC and CLTF of the EORTC Consensus guidelines (Olsen, 2011).
dispersion Type
95% Confidence Interval
groups
  1. description
    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
    Brentuximab Vedotin
  2. description
    Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m\^2, tablets, orally, once daily with meals for up to 48 weeks.
    id
    OG001
    title
    Methotrexate or Bexarotene
param Type
NUMBER
population Description
The ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment.
reporting Status
POSTED
time Frame
Each Cycle until disease progression, death or data cutoff (Median overall follow-up 38.8 months)
title
Percentage of Participants Achieving a CR
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice