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NCT05673785 · OUTCOME

Plasma Monomethyl Auristatin E (MMAE) Concentration

A Study of Brentuximab Vedotin in Combination With Cyclophosphamide, Doxorubicin (Hydroxydaunorubicin), Prednisone (CHP) in Chinese Participants With CD30-Positive (CD30+) Peripheral T-Cell Lymphomas (PTCL) · Source last updated 2026-06-12

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

Measure
MEAN
Unit
picogram per milliliter (pg/mL)
Interval / dispersion
Standard Deviation
Time frame
Cycle 1:Predose on Day1 and at 30minutes (min),48and 96hours postdose;Cycle 2:Predose on Day1 and at 30min,48 and 168hours postdose;Predose on Day1 of Cycles3,5,6,7;Anytime once on Days15,21 of Cycles4,6,8;30 days post-last dose; each cycle=21days

What was measured

The plasma concentration of MMAE is a critical factor in determining the efficacy and safety of ADCs.

Analysis population: The pharmacokinetic analysis set comprised of all participants who are in the FAS with at least 1 pharmacokinetic parameter. Here, "number analyzed" are the number of participants with data available for analysis at specified time-point.

Groups in this outcome

Brentuximab Vedotin + CHP

Participants received brentuximab vedotin 1.8 mg/kg, IV infusion, within 1 hour of completing treatment with other IV agents, i.e., cyclophosphamide 750 mg/m\^2 and doxorubicin 50 mg/m\^2, on Day 1 of each 21-day cycle, and prednisone tablets, 100 mg daily, orally, on Days 1 through 5, for up to 8 cycles (6 months) or until PD, unacceptable toxicity, 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
Brentuximab Vedotin + CHP52

Reported measurements

Cycle 1 - Predose

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin + CHP52
Values in picogram per milliliter (pg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin + CHP1070.00NANot reportedNot reportedStandard deviation was not estimable as only one participant had a quantifiable pre-dose concentration; the remaining values were below the limit of quantification (BLQ).
Cycle 1 - End of infusion (30 min)

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin + CHP52
Values in picogram per milliliter (pg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin + CHP342.80430.172Not reportedNot reportedNot reported
Cycle 1 - Day 3 (48 hr)

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin + CHP20
Values in picogram per milliliter (pg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin + CHP4038.502251.734Not reportedNot reportedNot reported
Cycle 1 - Day 5 (96 hr)

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin + CHP31
Values in picogram per milliliter (pg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin + CHP3664.392682.503Not reportedNot reportedNot reported
Cycle 2 - Predose

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin + CHP52
Values in picogram per milliliter (pg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin + CHP94.3583.847Not reportedNot reportedNot reported
Cycle 2 - End of infusion (30 min)

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin + CHP52
Values in picogram per milliliter (pg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin + CHP211.03142.401Not reportedNot reportedNot reported
Cycle 2 - Day 3 (48 hr)

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin + CHP31
Values in picogram per milliliter (pg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin + CHP1799.23502.966Not reportedNot reportedNot reported
Cycle 2 - Day 8 (168 hr)

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin + CHP20
Values in picogram per milliliter (pg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin + CHP1481.65661.914Not reportedNot reportedNot reported
Cycle 3 - Predose

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin + CHP50
Values in picogram per milliliter (pg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin + CHP91.2152.715Not reportedNot reportedNot reported
Cycle 4 - 15 to 21 Days Postdose

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin + CHP50
Values in picogram per milliliter (pg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin + CHP294.93251.617Not reportedNot reportedNot reported
Cycle 5 - Predose

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin + CHP50
Values in picogram per milliliter (pg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin + CHP107.1891.718Not reportedNot reportedNot reported
Cycle 6 - Predose

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin + CHP32
Values in picogram per milliliter (pg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin + CHP103.7977.201Not reportedNot reportedNot reported
Cycle 6 - 15 to 21 Days Postdose

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin + CHP26
Values in picogram per milliliter (pg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin + CHP329.65317.291Not reportedNot reportedNot reported
Cycle 7 - Predose

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin + CHP24
Values in picogram per milliliter (pg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin + CHP118.2693.931Not reportedNot reportedNot reported
Cycle 8 - 15 to 21 Days Postdose

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin + CHP24
Values in picogram per milliliter (pg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin + CHP241.97200.011Not reportedNot reportedNot reported
Last - 15 to 21 Days Postdose

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin + CHP50
Values in picogram per milliliter (pg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin + CHP286.70267.333Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Standard deviation was not estimable as only one participant had a quantifiable pre-dose concentration; the remaining values were below the limit of quantification (BLQ).
        group Id
        OG000
        spread
        NA
        value
        1070.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        52
      units
      Participants
    title
    Cycle 1 - Predose
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        430.172
        value
        342.80
    denoms
    1. counts
      1. group Id
        OG000
        value
        52
      units
      Participants
    title
    Cycle 1 - End of infusion (30 min)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        2251.734
        value
        4038.50
    denoms
    1. counts
      1. group Id
        OG000
        value
        20
      units
      Participants
    title
    Cycle 1 - Day 3 (48 hr)
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        2682.503
        value
        3664.39
    denoms
    1. counts
      1. group Id
        OG000
        value
        31
      units
      Participants
    title
    Cycle 1 - Day 5 (96 hr)
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        83.847
        value
        94.35
    denoms
    1. counts
      1. group Id
        OG000
        value
        52
      units
      Participants
    title
    Cycle 2 - Predose
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        142.401
        value
        211.03
    denoms
    1. counts
      1. group Id
        OG000
        value
        52
      units
      Participants
    title
    Cycle 2 - End of infusion (30 min)
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        502.966
        value
        1799.23
    denoms
    1. counts
      1. group Id
        OG000
        value
        31
      units
      Participants
    title
    Cycle 2 - Day 3 (48 hr)
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        661.914
        value
        1481.65
    denoms
    1. counts
      1. group Id
        OG000
        value
        20
      units
      Participants
    title
    Cycle 2 - Day 8 (168 hr)
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        52.715
        value
        91.21
    denoms
    1. counts
      1. group Id
        OG000
        value
        50
      units
      Participants
    title
    Cycle 3 - Predose
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        251.617
        value
        294.93
    denoms
    1. counts
      1. group Id
        OG000
        value
        50
      units
      Participants
    title
    Cycle 4 - 15 to 21 Days Postdose
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        91.718
        value
        107.18
    denoms
    1. counts
      1. group Id
        OG000
        value
        50
      units
      Participants
    title
    Cycle 5 - Predose
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        77.201
        value
        103.79
    denoms
    1. counts
      1. group Id
        OG000
        value
        32
      units
      Participants
    title
    Cycle 6 - Predose
denoms
  1. counts
    1. group Id
      OG000
      value
      52
    units
    Participants
description
The plasma concentration of MMAE is a critical factor in determining the efficacy and safety of ADCs.
dispersion Type
Standard Deviation
groups
  1. description
    Participants received brentuximab vedotin 1.8 mg/kg, IV infusion, within 1 hour of completing treatment with other IV agents, i.e., cyclophosphamide 750 mg/m\^2 and doxorubicin 50 mg/m\^2, on Day 1 of each 21-day cycle, and prednisone tablets, 100 mg daily, orally, on Days 1 through 5, for up to 8 cycles (6 months) or until PD, unacceptable toxicity, whichever occurred first.
    id
    OG000
    title
    Brentuximab Vedotin + CHP
param Type
MEAN
population Description
The pharmacokinetic analysis set comprised of all participants who are in the FAS with at least 1 pharmacokinetic parameter. Here, "number analyzed" are the number of participants with data available for analysis at specified time-point.
reporting Status
POSTED
time Frame
Cycle 1:Predose on Day1 and at 30minutes (min),48and 96hours postdose;Cycle 2:Predose on Day1 and at 30min,48 and 168hours postdose;Predose on Day1 of Cycles3,5,6,7;Anytime once on Days15,21 of Cycles4,6,8;30 days post-last dose; each cycle=21days
title
Plasma Monomethyl Auristatin E (MMAE) Concentration
type
SECONDARY
unit Of Measure
picogram per milliliter (pg/mL)

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Preserved source evidence · Not medical advice