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NCT02257567 · OUTCOME

Arm G+H (Phase II NF Cohorts): Plasma Concentration of Polatuzumab Vedotin Analyte: Total Ab

A Study of Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab or Obinutuzumab Plus Bendamustine in Participants With Relapsed or Refractory Follicular or Diffuse Large B-Cell Lymphoma · Source last updated 2022-11-14

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

Measure
MEAN
Unit
ng/mL
Interval / dispersion
Standard Deviation
Time frame
Cycle 1 Day 2: post dose; Cycle 2 and 4 Day 1: pre-dose and post dose

What was measured

PK of pola-related analyte: Total Ab was measured. Cycle length is 21 days for DLBCL cohorts. As pre-specified in the protocol data is reported combined for arms G+H.

Analysis population: PK evaluable population included all the ITT participants in Arm G+H (Phase II NF Cohort) who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoint.

Groups in this outcome

Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL

Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.

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

Analysis denominator · Participants

GroupSource count
Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL103

Reported measurements

Cycle 1 Day 2: Post Dose

Analysis denominator · Participants

GroupSource count
Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL103
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL33.911.7Not reportedNot reportedNot reported
Cycle 2 Day 1: Pre-dose

Analysis denominator · Participants

GroupSource count
Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL94
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL3.274.37Not reportedNot reportedNot reported
Cycle 2 Day 1: Post Dose

Analysis denominator · Participants

GroupSource count
Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL92
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL36.08.71Not reportedNot reportedNot reported
Cycle 4 Day 1: Pre-dose

Analysis denominator · Participants

GroupSource count
Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL63
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL5.411.79Not reportedNot reportedNot reported
Cycle 4 Day 1: Post Dose

Analysis denominator · Participants

GroupSource count
Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL61
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL39.27.30Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        11.7
        value
        33.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        103
      units
      Participants
    title
    Cycle 1 Day 2: Post Dose
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.37
        value
        3.27
    denoms
    1. counts
      1. group Id
        OG000
        value
        94
      units
      Participants
    title
    Cycle 2 Day 1: Pre-dose
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        8.71
        value
        36.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        92
      units
      Participants
    title
    Cycle 2 Day 1: Post Dose
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.79
        value
        5.41
    denoms
    1. counts
      1. group Id
        OG000
        value
        63
      units
      Participants
    title
    Cycle 4 Day 1: Pre-dose
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        7.30
        value
        39.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        61
      units
      Participants
    title
    Cycle 4 Day 1: Post Dose
denoms
  1. counts
    1. group Id
      OG000
      value
      103
    units
    Participants
description
PK of pola-related analyte: Total Ab was measured. Cycle length is 21 days for DLBCL cohorts. As pre-specified in the protocol data is reported combined for arms G+H.
dispersion Type
Standard Deviation
groups
  1. description
    Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.
    id
    OG000
    title
    Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL
param Type
MEAN
population Description
PK evaluable population included all the ITT participants in Arm G+H (Phase II NF Cohort) who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoint.
reporting Status
POSTED
time Frame
Cycle 1 Day 2: post dose; Cycle 2 and 4 Day 1: pre-dose and post dose
title
Arm G+H (Phase II NF Cohorts): Plasma Concentration of Polatuzumab Vedotin Analyte: Total Ab
type
SECONDARY
unit Of Measure
ng/mL

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Preserved source evidence · Not medical advice