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NCT01492088 · OUTCOME

Overall Survival (OS) (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
Every 6 months after EOT, until the sooner of death, study closure, or 2 years after enrolment of the last participant (Up to 72 months)

What was measured

OS is the time in months from start of study treatment to date of death due to any cause.

Analysis population: Safety population is defined as all participants who received at least 1 dose of study drug.

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

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin 1.4 mg/kg: Phase 1NANot reportedNANAMedian was not reached due to low number of participants with events.
Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL OnlyNANot reportedNANAMedian was not reached due to low number of participants with events.
Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL OnlyNANot reportedNANAMedian 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 due to low number of participants with events.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        Median was not reached due to low number of participants with events.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      3. comment
        Median was not reached due to low number of participants with events.
        group Id
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      16
    3. group Id
      OG002
      value
      17
    units
    Participants
description
OS is the time in months from start of study treatment to date of death due to any cause.
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
Safety population is defined as all participants who received at least 1 dose of study drug.
reporting Status
POSTED
time Frame
Every 6 months after EOT, until the sooner of death, study closure, or 2 years after enrolment of the last participant (Up to 72 months)
title
Overall Survival (OS) (Phase 1 and 2)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice