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NCT03589469 · OUTCOME

Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) 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
day*ng/mL
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

Analysis population: 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-Cycle 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 Tesirine143

Reported measurements

Conjugated Antibody Cycle 1

Analysis denominator · Participants

GroupSource count
Loncastuximab Tesirine143
Values in day*ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Loncastuximab Tesirine15850105Not reportedNot reportedNot reported
Conjugated Antibody Cycle 2

Analysis denominator · Participants

GroupSource count
Loncastuximab Tesirine116
Values in day*ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Loncastuximab Tesirine2391367.1Not reportedNot reportedNot reported
Conjugated Antibody Cycle 3

Analysis denominator · Participants

GroupSource count
Loncastuximab Tesirine0
Total Antibody Cycle 1

Analysis denominator · Participants

GroupSource count
Loncastuximab Tesirine143
Values in day*ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Loncastuximab Tesirine22160106Not reportedNot reportedNot reported
Total Antibody Cycle 2

Analysis denominator · Participants

GroupSource count
Loncastuximab Tesirine116
Values in day*ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Loncastuximab Tesirine3376267.2Not reportedNot reportedNot reported
Total Antibody Cycle 3

Analysis denominator · Participants

GroupSource count
Loncastuximab Tesirine0
SG3199 Cycle 1

Analysis denominator · Participants

GroupSource count
Loncastuximab Tesirine8
Values in day*ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Loncastuximab Tesirine0.00400576Not reportedNot reportedNot reported
SG3199 Cycle 2

Analysis denominator · Participants

GroupSource count
Loncastuximab Tesirine5
Values in day*ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Loncastuximab Tesirine0.00100204Not reportedNot reportedNot reported
SG3199 Cycle 3

Analysis denominator · Participants

GroupSource count
Loncastuximab Tesirine0
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        105
        value
        15850
    denoms
    1. counts
      1. group Id
        OG000
        value
        143
      units
      Participants
    title
    Conjugated Antibody Cycle 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        67.1
        value
        23913
    denoms
    1. counts
      1. group Id
        OG000
        value
        116
      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. categories
    1. measurements
      1. group Id
        OG000
        spread
        106
        value
        22160
    denoms
    1. counts
      1. group Id
        OG000
        value
        143
      units
      Participants
    title
    Total Antibody Cycle 1
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        67.2
        value
        33762
    denoms
    1. counts
      1. group Id
        OG000
        value
        116
      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. categories
    1. measurements
      1. group Id
        OG000
        spread
        576
        value
        0.00400
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      units
      Participants
    title
    SG3199 Cycle 1
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        204
        value
        0.00100
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      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
      143
    units
    Participants
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
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-Cycle 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
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199
type
SECONDARY
unit Of Measure
day*ng/mL

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Preserved source evidence · Not medical advice