Skip to content
← Full study record

NCT03105336 · OUTCOME

Percentage of Participants With CR Per the Lugano Classification by Central Assessment

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 in outcome measure (OM)#1. Percentages were rounded-off.

Analysis population: Participants 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)127
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)29

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Axicabtagene Ciloleucel (Follicular Lymphoma)78Not reported7085Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)52Not reported3371Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        70
        upper Limit
        85
        value
        78
      2. group Id
        OG001
        lower Limit
        33
        upper Limit
        71
        value
        52
denoms
  1. counts
    1. group Id
      OG000
      value
      127
    2. group Id
      OG001
      value
      29
    units
    Participants
description
CR is defined in outcome measure (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 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 the Lugano Classification by Central Assessment
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice