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NCT02445248 · OUTCOME

Incidence of Immunogenicity to CTL019

Study of Efficacy and Safety of CTL019 in Adult DLBCL Patients · Source last updated 2024-04-18

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
pre-infusion and at any time point post-baseline, up to duration of the study, up to 5 years

What was measured

This is defined as the percentage of participants who tested positive for anti-mCAR19 antibodies at any time post-baseline, reported by complete response (CR), partial response (PR), Stable disease (SD), progressive disease (SD), Unknown for all participants who received with tisagenlecleucel.

Analysis population: Full Analysis Set (FAS): Comprised all patients who received infusion of tisagenlecleucel.

Groups in this outcome

Tisagenlecleucel - All Participants Response

Participants with complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD) and unknown (UNK) response post-tisagenlecleucel infusion.

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

Analysis denominator · Participants

GroupSource count
Tisagenlecleucel - All Participants Response115

Reported measurements

Complete response

Analysis denominator · Participants

GroupSource count
Tisagenlecleucel - All Participants Response37
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tisagenlecleucel - All Participants Response36Not reportedNot reportedNot reportedNot reported
Partial response

Analysis denominator · Participants

GroupSource count
Tisagenlecleucel - All Participants Response7
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tisagenlecleucel - All Participants Response6Not reportedNot reportedNot reportedNot reported
Stable disease

Analysis denominator · Participants

GroupSource count
Tisagenlecleucel - All Participants Response1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tisagenlecleucel - All Participants Response1Not reportedNot reportedNot reportedNot reported
Progressive disease

Analysis denominator · Participants

GroupSource count
Tisagenlecleucel - All Participants Response54
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tisagenlecleucel - All Participants Response50Not reportedNot reportedNot reportedNot reported
Unknown

Analysis denominator · Participants

GroupSource count
Tisagenlecleucel - All Participants Response16
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tisagenlecleucel - All Participants Response14Not reportedNot reportedNot reportedNot reported
All Participants

Analysis denominator · Participants

GroupSource count
Tisagenlecleucel - All Participants Response115
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tisagenlecleucel - All Participants Response107Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        36
    denoms
    1. counts
      1. group Id
        OG000
        value
        37
      units
      Participants
    title
    Complete response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        6
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      units
      Participants
    title
    Partial response
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    Stable disease
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        50
    denoms
    1. counts
      1. group Id
        OG000
        value
        54
      units
      Participants
    title
    Progressive disease
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        14
    denoms
    1. counts
      1. group Id
        OG000
        value
        16
      units
      Participants
    title
    Unknown
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        107
    denoms
    1. counts
      1. group Id
        OG000
        value
        115
      units
      Participants
    title
    All Participants
denoms
  1. counts
    1. group Id
      OG000
      value
      115
    units
    Participants
description
This is defined as the percentage of participants who tested positive for anti-mCAR19 antibodies at any time post-baseline, reported by complete response (CR), partial response (PR), Stable disease (SD), progressive disease (SD), Unknown for all participants who received with tisagenlecleucel.
groups
  1. description
    Participants with complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD) and unknown (UNK) response post-tisagenlecleucel infusion.
    id
    OG000
    title
    Tisagenlecleucel - All Participants Response
param Type
COUNT_OF_PARTICIPANTS
population Description
Full Analysis Set (FAS): Comprised all patients who received infusion of tisagenlecleucel.
reporting Status
POSTED
time Frame
pre-infusion and at any time point post-baseline, up to duration of the study, up to 5 years
title
Incidence of Immunogenicity to CTL019
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice