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NCT03372057 · OUTCOME

Overall Survival (OS)

A Study of Duvelisib in Participants With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL) · Source last updated 2025-03-07

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

Measure
MEDIAN
Unit
month
Interval / dispersion
95% Confidence Interval
Time frame
Up to 70 months

What was measured

OS was defined as the time from the date of first treatment to the date of death due to any cause. Participants without documented death were censored at last alive date.

Analysis population: Dose Optimization Efficacy Set: All participants who received at least one dose of study drug, completed at least one cycle of treatment, and had at least one scan to assess disease response after completion of one cycle of treatment. Modified Intent-to-treat (mITT): all participants who receive at least one dose of study drug. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure.

Groups in this outcome

Dose Optimization Phase: Cohort 1

Duvelisib PO BID at a starting dose of 25 mg, with potential escalation on a per-participant basis to 50 mg and then 75 mg, based on the participant's response to and tolerance of therapy, in 28-day cycles.

Dose Optimization Phase: Cohort 2

Duvelisib 75 mg PO BID, administered in 28-day cycles.

Expansion Phase

Duvelisib PO BID at a starting dose of 75 mg for the first 2 cycles, followed by a mandatory reduction to 25 mg BID thereafter for those participants with CR, PR or SD, in 28-day cycles (dose determined in Optimization Phase).

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

Analysis denominator · Participants

GroupSource count
Dose Optimization Phase: Cohort 19
Dose Optimization Phase: Cohort 211
Expansion Phase78

Reported measurements

Source class 1
Values in month · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dose Optimization Phase: Cohort 16.70Not reported5.22NAInsufficient number of participants with events to calculate the upper confidence interval.
Dose Optimization Phase: Cohort 210.58Not reported6.6744.62Not reported
Expansion Phase12.4Not reported8.422.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Insufficient number of participants with events to calculate the upper confidence interval.
        group Id
        OG000
        lower Limit
        5.22
        upper Limit
        NA
        value
        6.70
      2. group Id
        OG001
        lower Limit
        6.67
        upper Limit
        44.62
        value
        10.58
      3. group Id
        OG002
        lower Limit
        8.4
        upper Limit
        22.7
        value
        12.4
denoms
  1. counts
    1. group Id
      OG000
      value
      9
    2. group Id
      OG001
      value
      11
    3. group Id
      OG002
      value
      78
    units
    Participants
description
OS was defined as the time from the date of first treatment to the date of death due to any cause. Participants without documented death were censored at last alive date.
dispersion Type
95% Confidence Interval
groups
  1. description
    Duvelisib PO BID at a starting dose of 25 mg, with potential escalation on a per-participant basis to 50 mg and then 75 mg, based on the participant's response to and tolerance of therapy, in 28-day cycles.
    id
    OG000
    title
    Dose Optimization Phase: Cohort 1
  2. description
    Duvelisib 75 mg PO BID, administered in 28-day cycles.
    id
    OG001
    title
    Dose Optimization Phase: Cohort 2
  3. description
    Duvelisib PO BID at a starting dose of 75 mg for the first 2 cycles, followed by a mandatory reduction to 25 mg BID thereafter for those participants with CR, PR or SD, in 28-day cycles (dose determined in Optimization Phase).
    id
    OG002
    title
    Expansion Phase
param Type
MEDIAN
population Description
Dose Optimization Efficacy Set: All participants who received at least one dose of study drug, completed at least one cycle of treatment, and had at least one scan to assess disease response after completion of one cycle of treatment. Modified Intent-to-treat (mITT): all participants who receive at least one dose of study drug. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure.
reporting Status
POSTED
time Frame
Up to 70 months
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
month

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

Preserved source evidence · Not medical advice