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NCT03493451 · OUTCOME

Time to Response (TTR)

Study of BGB-A317 in Participants With Relapsed or Refractory Mature T- and NK-cell Neoplasms · Source last updated 2024-10-26

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

Measure
MEDIAN
Unit
Months
Interval / dispersion
Full Range
Time frame
Up to approximately 3 years and 1 week

What was measured

Time to response defined as the time from first study drug administration to the time the response criteria (complete response or partial response) are first met as assessed by the investigator using Lugano criteria with LYRIC modification for cohorts 1 and 2 and ISCL/EORTC guidelines for cohort 3.

Analysis population: Safety analysis set includes all participants who received at least one dose of study drug; Time to response was summarized for responders (participants who achieved a partial or complete response).

Groups in this outcome

Cohort 1: ENKTL

Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)

Cohort 2: PTCL-NOS, AITL, and ALCL

Participants with other R/R mature T-cell neoplasms \[limited to peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large-cell lymphoma (ALCL)\] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)

Cohort 3: MF and SS

Participants with R/R cutaneous T-cell lymphoma \[limited to mycosis fungoides (MF) and Sèzary syndrome (SS)\] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)

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

Analysis denominator · Participants

GroupSource count
Cohort 1: ENKTL7
Cohort 2: PTCL-NOS, AITL, and ALCL9
Cohort 3: MF and SS5

Reported measurements

Source class 1
Values in Months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Cohort 1: ENKTL5.75Not reported2.113.9Not reported
Cohort 2: PTCL-NOS, AITL, and ALCL2.86Not reported2.15.5Not reported
Cohort 3: MF and SS6.83Not reported2.611.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.1
        upper Limit
        13.9
        value
        5.75
      2. group Id
        OG001
        lower Limit
        2.1
        upper Limit
        5.5
        value
        2.86
      3. group Id
        OG002
        lower Limit
        2.6
        upper Limit
        11.1
        value
        6.83
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      9
    3. group Id
      OG002
      value
      5
    units
    Participants
description
Time to response defined as the time from first study drug administration to the time the response criteria (complete response or partial response) are first met as assessed by the investigator using Lugano criteria with LYRIC modification for cohorts 1 and 2 and ISCL/EORTC guidelines for cohort 3.
dispersion Type
Full Range
groups
  1. description
    Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
    id
    OG000
    title
    Cohort 1: ENKTL
  2. description
    Participants with other R/R mature T-cell neoplasms \[limited to peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large-cell lymphoma (ALCL)\] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
    id
    OG001
    title
    Cohort 2: PTCL-NOS, AITL, and ALCL
  3. description
    Participants with R/R cutaneous T-cell lymphoma \[limited to mycosis fungoides (MF) and Sèzary syndrome (SS)\] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
    id
    OG002
    title
    Cohort 3: MF and SS
param Type
MEDIAN
population Description
Safety analysis set includes all participants who received at least one dose of study drug; Time to response was summarized for responders (participants who achieved a partial or complete response).
reporting Status
POSTED
time Frame
Up to approximately 3 years and 1 week
title
Time to Response (TTR)
type
SECONDARY
unit Of Measure
Months

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice