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NCT03589469 · OUTCOME

Accumulation Index (AI) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199

Study to Evaluate the Efficacy and Safety of Loncastuximab Tesirine in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma · Source last updated 2023-08-29

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

Measure
GEOMETRIC_MEAN
Unit
ratio
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Cycles 1 and 2: Day 1 pre-dose, and at 0, 4, 168 and 336 hours post-dose; Cycle 3: Day 1 pre-dose

What was measured

AI is the ratio of AUC0-last for each cycle divided by AUC0-last of the previous cycle.

Analysis population: Pharmacokinetic (PK) population: All participants in the per-protocol population (all participants in the all-treated population without major protocol deviations) with at least 1 pre- Cyle 1 Day 1 and 1 post-dose valid assessment. Only participants with data available for analysis are presented.

Groups in this outcome

Loncastuximab Tesirine

Participants received loncastuximab tesirine as an IV infusion over 30 minutes on Day 1 of each cycle (every 3 weeks) at a dose of 150 μg/kg Q3W for 2 cycles, then 75 μg/kg Q3W for subsequent cycles for up to one year or until disease progression, unacceptable toxicity, or other discontinuation criteria, whichever occurred first.

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

Analysis denominator · Participants

GroupSource count
Loncastuximab Tesirine90

Reported measurements

Conjugated Antibody Cycle 1

Analysis denominator · Participants

GroupSource count
Loncastuximab Tesirine0
Conjugated Antibody Cycle 2

Analysis denominator · Participants

GroupSource count
Loncastuximab Tesirine90
Values in ratio · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Loncastuximab Tesirine1.6518.5Not reportedNot reportedNot reported
Conjugated Antibody Cycle 3

Analysis denominator · Participants

GroupSource count
Loncastuximab Tesirine0
Total Antibody Cycle 1

Analysis denominator · Participants

GroupSource count
Loncastuximab Tesirine0
Total Antibody Cycle 2

Analysis denominator · Participants

GroupSource count
Loncastuximab Tesirine63
Values in ratio · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Loncastuximab Tesirine2.0738.1Not reportedNot reportedNot reported
Total Antibody Cycle 3

Analysis denominator · Participants

GroupSource count
Loncastuximab Tesirine0
SG3199 Cycle 1

Analysis denominator · Participants

GroupSource count
Loncastuximab Tesirine0
SG3199 Cycle 2

Analysis denominator · Participants

GroupSource count
Loncastuximab Tesirine0
SG3199 Cycle 3

Analysis denominator · Participants

GroupSource count
Loncastuximab Tesirine0
Complete source fields
classes
  1. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      units
      Participants
    title
    Conjugated Antibody Cycle 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        18.5
        value
        1.65
    denoms
    1. counts
      1. group Id
        OG000
        value
        90
      units
      Participants
    title
    Conjugated Antibody Cycle 2
  3. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      units
      Participants
    title
    Conjugated Antibody Cycle 3
  4. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      units
      Participants
    title
    Total Antibody Cycle 1
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        38.1
        value
        2.07
    denoms
    1. counts
      1. group Id
        OG000
        value
        63
      units
      Participants
    title
    Total Antibody Cycle 2
  6. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      units
      Participants
    title
    Total Antibody Cycle 3
  7. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      units
      Participants
    title
    SG3199 Cycle 1
  8. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      units
      Participants
    title
    SG3199 Cycle 2
  9. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      units
      Participants
    title
    SG3199 Cycle 3
denoms
  1. counts
    1. group Id
      OG000
      value
      90
    units
    Participants
description
AI is the ratio of AUC0-last for each cycle divided by AUC0-last of the previous cycle.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants received loncastuximab tesirine as an IV infusion over 30 minutes on Day 1 of each cycle (every 3 weeks) at a dose of 150 μg/kg Q3W for 2 cycles, then 75 μg/kg Q3W for subsequent cycles for up to one year or until disease progression, unacceptable toxicity, or other discontinuation criteria, whichever occurred first.
    id
    OG000
    title
    Loncastuximab Tesirine
param Type
GEOMETRIC_MEAN
population Description
Pharmacokinetic (PK) population: All participants in the per-protocol population (all participants in the all-treated population without major protocol deviations) with at least 1 pre- Cyle 1 Day 1 and 1 post-dose valid assessment. Only participants with data available for analysis are presented.
reporting Status
POSTED
time Frame
Cycles 1 and 2: Day 1 pre-dose, and at 0, 4, 168 and 336 hours post-dose; Cycle 3: Day 1 pre-dose
title
Accumulation Index (AI) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199
type
SECONDARY
unit Of Measure
ratio

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Preserved source evidence · Not medical advice