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NCT05673785 · OUTCOME

Serum Antibody-Drug Conjugate (ADC) 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
nanograms per milliliter (ng/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

Antibody-Drug Conjugates (ADCs) are targeted cancer therapies that combine a monoclonal antibody with a cytotoxic drug to selectively deliver treatment to cancer cells while minimizing damage to healthy cells.

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 + CHP51
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin + CHPNANANot reportedNot reportedMean and standard deviation were not estimable as no participant had detectable ADC at the pre-dose collection time point.
Cycle 1 - End of infusion (30 min)

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin + CHP51
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin + CHP32278.63106782.22537Not reportedNot reportedNot reported
Cycle 1 - Day 3 (48 hr)

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin + CHP20
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin + CHP8017.26243262.42585Not reportedNot reportedNot reported
Cycle 1 - Day 5 (96 hr)

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin + CHP31
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin + CHP4703.55791795.74382Not reportedNot reportedNot reported
Cycle 2 - Predose

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin + CHP52
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin + CHP364.0768151.95902Not reportedNot reportedNot reported
Cycle 2 - End of infusion (30 min)

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin + CHP52
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin + CHP31953.27298062.68391Not reportedNot reportedNot reported
Cycle 2 - Day 3 (48 hr)

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin + CHP31
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin + CHP8944.77273432.10921Not reportedNot reportedNot reported
Cycle 2 - Day 8 (168 hr)

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin + CHP20
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin + CHP2674.7550626.08923Not reportedNot reportedNot reported
Cycle 3 - Predose

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin + CHP50
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin + CHP558.8526181.81833Not reportedNot reportedNot reported
Cycle 4 - 15 to 21 Days Postdose

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin + CHP50
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin + CHP1044.3557361.75958Not reportedNot reportedNot reported
Cycle 5 - Predose

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin + CHP50
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin + CHP617.9578247.80106Not reportedNot reportedNot reported
Cycle 6 - Predose

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin + CHP33
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin + CHP623.6881178.29961Not reportedNot reportedNot reported
Cycle 6 - 15 to 21 Days Postdose

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin + CHP26
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin + CHP1052.5095412.67066Not reportedNot reportedNot reported
Cycle 7 - Predose

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin + CHP24
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin + CHP660.0101198.78143Not reportedNot reportedNot reported
Cycle 8 - 15 to 21 Days Postdose

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin + CHP24
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin + CHP1091.6060364.72862Not reportedNot reportedNot reported
Last - 15 to 21 Days Postdose

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin + CHP50
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin + CHP1071.2758386.93255Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Mean and standard deviation were not estimable as no participant had detectable ADC at the pre-dose collection time point.
        group Id
        OG000
        spread
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        51
      units
      Participants
    title
    Cycle 1 - Predose
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        6782.22537
        value
        32278.6310
    denoms
    1. counts
      1. group Id
        OG000
        value
        51
      units
      Participants
    title
    Cycle 1 - End of infusion (30 min)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        3262.42585
        value
        8017.2624
    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
        1795.74382
        value
        4703.5579
    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
        151.95902
        value
        364.0768
    denoms
    1. counts
      1. group Id
        OG000
        value
        52
      units
      Participants
    title
    Cycle 2 - Predose
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        8062.68391
        value
        31953.2729
    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
        3432.10921
        value
        8944.7727
    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
        626.08923
        value
        2674.7550
    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
        181.81833
        value
        558.8526
    denoms
    1. counts
      1. group Id
        OG000
        value
        50
      units
      Participants
    title
    Cycle 3 - Predose
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        361.75958
        value
        1044.3557
    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
        247.80106
        value
        617.9578
    denoms
    1. counts
      1. group Id
        OG000
        value
        50
      units
      Participants
    title
    Cycle 5 - Predose
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        178.29961
        value
        623.6881
    denoms
    1. counts
      1. group Id
        OG000
        value
        33
      units
      Participants
    title
    Cycle 6 - Predose
denoms
  1. counts
    1. group Id
      OG000
      value
      52
    units
    Participants
description
Antibody-Drug Conjugates (ADCs) are targeted cancer therapies that combine a monoclonal antibody with a cytotoxic drug to selectively deliver treatment to cancer cells while minimizing damage to healthy cells.
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
Serum Antibody-Drug Conjugate (ADC) Concentration
type
SECONDARY
unit Of Measure
nanograms per milliliter (ng/mL)

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Preserved source evidence · Not medical advice