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NCT03105336 · OUTCOME

Percentage of Participants With Best Overall Response (BOR) 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

BOR was defined as percentage of participants with CR, PR, stable disease(SD), disease progression(PD), non-evaluable(NE), undefined/no disease or not done as best response to treatment by the Lugano Classification. CR and PR defined in OM#1. SD/no metabolic response(NMR):score 4(uptake moderately greater than (\>) liver) or 5(uptake markedly\>liver and/ or new lesions) with no significant change in fluorodeoxyglucose(FDG) uptake compared to baseline(screening), at interim time point or end of treatment; no new sites of disease should be observed. PD:score 4(uptake moderately\>liver) or 5(uptake markedly\>liver and/or new lesions) with an increase in intensity of uptake from baseline; new FDG-avid foci consistent with lymphoma at interim or end of treatment assessment; new FDG-avid foci consistent with lymphoma rather than another etiology (eg, infection, inflammation); new or recurrent FDG-avid foci in bone marrow. Not done:no assessment at time of analysis. 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

CR
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
PR
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Axicabtagene Ciloleucel (Follicular Lymphoma)14Not reported921Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)17Not reported636Not reported
SD
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Axicabtagene Ciloleucel (Follicular Lymphoma)4Not reported19Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)0Not reported012Not reported
PD
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Axicabtagene Ciloleucel (Follicular Lymphoma)0Not reported03Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)3Not reported018Not reported
Non-evaluable
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Axicabtagene Ciloleucel (Follicular Lymphoma)0Not reported03Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)0Not reported012Not reported
Undefined/ No Disease
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Axicabtagene Ciloleucel (Follicular Lymphoma)1Not reported04Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)10Not reported227Not reported
Not Done
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Axicabtagene Ciloleucel (Follicular Lymphoma)3Not reported18Not reported
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)17Not reported636Not 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
    title
    CR
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        9
        upper Limit
        21
        value
        14
      2. group Id
        OG001
        lower Limit
        6
        upper Limit
        36
        value
        17
    title
    PR
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1
        upper Limit
        9
        value
        4
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        12
        value
        0
    title
    SD
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        3
        value
        0
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        18
        value
        3
    title
    PD
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        3
        value
        0
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        12
        value
        0
    title
    Non-evaluable
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        4
        value
        1
      2. group Id
        OG001
        lower Limit
        2
        upper Limit
        27
        value
        10
    title
    Undefined/ No Disease
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1
        upper Limit
        8
        value
        3
      2. group Id
        OG001
        lower Limit
        6
        upper Limit
        36
        value
        17
    title
    Not Done
denoms
  1. counts
    1. group Id
      OG000
      value
      127
    2. group Id
      OG001
      value
      29
    units
    Participants
description
BOR was defined as percentage of participants with CR, PR, stable disease(SD), disease progression(PD), non-evaluable(NE), undefined/no disease or not done as best response to treatment by the Lugano Classification. CR and PR defined in OM#1. SD/no metabolic response(NMR):score 4(uptake moderately greater than (\>) liver) or 5(uptake markedly\>liver and/ or new lesions) with no significant change in fluorodeoxyglucose(FDG) uptake compared to baseline(screening), at interim time point or end of treatment; no new sites of disease should be observed. PD:score 4(uptake moderately\>liver) or 5(uptake markedly\>liver and/or new lesions) with an increase in intensity of uptake from baseline; new FDG-avid foci consistent with lymphoma at interim or end of treatment assessment; new FDG-avid foci consistent with lymphoma rather than another etiology (eg, infection, inflammation); new or recurrent FDG-avid foci in bone marrow. Not done:no assessment at time of analysis. 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 Best Overall Response (BOR) 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