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NCT03105336 · OUTCOME

Time to Next Therapy

A Study of Axicabtagene Ciloleucel in Participants With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma · Source last updated 2025-12-23

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
Up to 85.6 months

What was measured

Time from axicabtagene ciloleucel infusion date to the start of the subsequent new lymphoma therapy or death from any cause. KM estimates were used for analysis.

Analysis population: Participants in the Full Analysis Set were analyzed.

Groups in this outcome

Axicabtagene Ciloleucel (Follicular Lymphoma)

Participants with r/r B-cell iNHL subtype of FL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.

Axicabtagene Ciloleucel (Marginal Zone Lymphoma)

Participants with r/r B-cell iNHL subtype of MZL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.

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

Analysis denominator · Participants

GroupSource count
Axicabtagene Ciloleucel (Follicular Lymphoma)127
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)31

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Axicabtagene Ciloleucel (Follicular Lymphoma)NANot reported37.8NAData for median and upper limit of CI were not estimable due to low number of participants with events.
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)NANot reported12.1NAData for median and upper limit of CI were not estimable due to low number of participants with events.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Data for median and upper limit of CI were not estimable due to low number of participants with events.
        group Id
        OG000
        lower Limit
        37.8
        upper Limit
        NA
        value
        NA
      2. comment
        Data for median and upper limit of CI were not estimable due to low number of participants with events.
        group Id
        OG001
        lower Limit
        12.1
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      127
    2. group Id
      OG001
      value
      31
    units
    Participants
description
Time from axicabtagene ciloleucel infusion date to the start of the subsequent new lymphoma therapy or death from any cause. KM estimates were used for analysis.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with r/r B-cell iNHL subtype of FL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
    id
    OG000
    title
    Axicabtagene Ciloleucel (Follicular Lymphoma)
  2. description
    Participants with r/r B-cell iNHL subtype of MZL received the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
    id
    OG001
    title
    Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
param Type
MEDIAN
population Description
Participants in the Full Analysis Set were analyzed.
reporting Status
POSTED
time Frame
Up to 85.6 months
title
Time to Next Therapy
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice