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NCT03589469 · OUTCOME

Maximum Concentration (Cmax) 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
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 and end of infusion

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-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 Tesirine142

Reported measurements

Conjugated Antibody Cycle 1

Analysis denominator · Participants

GroupSource count
Loncastuximab Tesirine142
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Loncastuximab Tesirine243038.8Not reportedNot reportedNot reported
Conjugated Antibody Cycle 2

Analysis denominator · Participants

GroupSource count
Loncastuximab Tesirine117
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Loncastuximab Tesirine273435.8Not reportedNot reportedNot reported
Conjugated Antibody Cycle 3

Analysis denominator · Participants

GroupSource count
Loncastuximab Tesirine83
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Loncastuximab Tesirine169447.6Not reportedNot reportedNot reported
Total Antibody Cycle 1

Analysis denominator · Participants

GroupSource count
Loncastuximab Tesirine142
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Loncastuximab Tesirine326736.7Not reportedNot reportedNot reported
Total Antibody Cycle 2

Analysis denominator · Participants

GroupSource count
Loncastuximab Tesirine117
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Loncastuximab Tesirine375631.3Not reportedNot reportedNot reported
Total Antibody Cycle 3

Analysis denominator · Participants

GroupSource count
Loncastuximab Tesirine81
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Loncastuximab Tesirine258141.9Not reportedNot reportedNot reported
SG3199 Cycle 1

Analysis denominator · Participants

GroupSource count
Loncastuximab Tesirine8
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Loncastuximab Tesirine0.041056.6Not reportedNot reportedNot reported
SG3199 Cycle 2

Analysis denominator · Participants

GroupSource count
Loncastuximab Tesirine5
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Loncastuximab Tesirine0.049078.8Not reportedNot reportedNot reported
SG3199 Cycle 3

Analysis denominator · Participants

GroupSource count
Loncastuximab Tesirine3
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Loncastuximab Tesirine0.032020.3Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        38.8
        value
        2430
    denoms
    1. counts
      1. group Id
        OG000
        value
        142
      units
      Participants
    title
    Conjugated Antibody Cycle 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        35.8
        value
        2734
    denoms
    1. counts
      1. group Id
        OG000
        value
        117
      units
      Participants
    title
    Conjugated Antibody Cycle 2
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        47.6
        value
        1694
    denoms
    1. counts
      1. group Id
        OG000
        value
        83
      units
      Participants
    title
    Conjugated Antibody Cycle 3
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        36.7
        value
        3267
    denoms
    1. counts
      1. group Id
        OG000
        value
        142
      units
      Participants
    title
    Total Antibody Cycle 1
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        31.3
        value
        3756
    denoms
    1. counts
      1. group Id
        OG000
        value
        117
      units
      Participants
    title
    Total Antibody Cycle 2
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        41.9
        value
        2581
    denoms
    1. counts
      1. group Id
        OG000
        value
        81
      units
      Participants
    title
    Total Antibody Cycle 3
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        56.6
        value
        0.0410
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      units
      Participants
    title
    SG3199 Cycle 1
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        78.8
        value
        0.0490
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      units
      Participants
    title
    SG3199 Cycle 2
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.3
        value
        0.0320
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      units
      Participants
    title
    SG3199 Cycle 3
denoms
  1. counts
    1. group Id
      OG000
      value
      142
    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
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-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 and end of infusion
title
Maximum Concentration (Cmax) of Loncastuximab Tesirine Conjugated Antibody, Total Antibody and Warhead SG3199
type
SECONDARY
unit Of Measure
ng/mL

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Preserved source evidence · Not medical advice