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NCT03105336 · OUTCOME

Percentage of Participants With CR Per Lugano Classification by Central Assessment Among Participants With 3 or More Lines of Prior 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
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Up to 85.6 months

What was measured

CR is defined as OM#1. Percentages were rounded-off.

Analysis population: Participants with 3 or more lines of prior therapy in the Full Analysis Set with available data 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)80
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)20

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Axicabtagene Ciloleucel (Follicular Lymphoma)79Not reported6887Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)60Not reported3681Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        68
        upper Limit
        87
        value
        79
      2. group Id
        OG001
        lower Limit
        36
        upper Limit
        81
        value
        60
denoms
  1. counts
    1. group Id
      OG000
      value
      80
    2. group Id
      OG001
      value
      20
    units
    Participants
description
CR is defined as OM#1. Percentages were rounded-off.
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
NUMBER
population Description
Participants with 3 or more lines of prior therapy in the Full Analysis Set with available data were analyzed
reporting Status
POSTED
time Frame
Up to 85.6 months
title
Percentage of Participants With CR Per Lugano Classification by Central Assessment Among Participants With 3 or More Lines of Prior Therapy
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice