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NCT01492088 · OUTCOME

Time to Response (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
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or EOT (Up to 15 months)

What was measured

Time to response is defined as the time in months from the first dose of study treatment until the date of the first assessment of confirmed CR or PR. as assessed by an IRF using IWG revised response criteria for malignant lymphoma. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites.

Analysis population: Response-evaluable population included participants who received at least 1 dose of study drug, have measurable disease at baseline, and 1 postbaseline disease assessment. Time to response was censored on the last radiological assessment of measured lesions documenting absence of CR or PR for participants who did not have CR or PR.

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 Only15
Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only17

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin 1.4 mg/kg: Phase 1NANot reportedNANAMedian was not reached as no participant had response.
Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only2.7Not reported1.3NAUpper limit of CI was not reached due to low number of participants with events.
Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only1.5Not reported1.2NAUpper limit of CI was not reached due to low number of participants with events.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Median was not reached as no participant had response.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        Upper limit of CI was not reached due to low number of participants with events.
        group Id
        OG001
        lower Limit
        1.3
        upper Limit
        NA
        value
        2.7
      3. comment
        Upper limit of CI was not reached due to low number of participants with events.
        group Id
        OG002
        lower Limit
        1.2
        upper Limit
        NA
        value
        1.5
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      15
    3. group Id
      OG002
      value
      17
    units
    Participants
description
Time to response is defined as the time in months from the first dose of study treatment until the date of the first assessment of confirmed CR or PR. as assessed by an IRF using IWG revised response criteria for malignant lymphoma. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites.
dispersion Type
95% Confidence Interval
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
MEDIAN
population Description
Response-evaluable population included participants who received at least 1 dose of study drug, have measurable disease at baseline, and 1 postbaseline disease assessment. Time to response was censored on the last radiological assessment of measured lesions documenting absence of CR or PR for participants who did not have CR or PR.
reporting Status
POSTED
time Frame
Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or EOT (Up to 15 months)
title
Time to Response (Phase 1 and 2)
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice