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NCT02257567 · OUTCOME

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

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 1 and 3 Day 8 and 15; Cycle 2, 3 and 4 Day 1: pre-dose and post dose

What was measured

PK of one pola-related analytes: Unconjugated MMAE 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 (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 DLBCL0.5901.08Not 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 DLBCL0.2290.248Not reportedNot reportedNot reported
Cycle 2 Day 1: Post Dose

Analysis denominator · Participants

GroupSource count
Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL91
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL0.3160.213Not reportedNot reportedNot reported
Cycle 4 Day 1: Pre-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 DLBCL0.1860.118Not reportedNot reportedNot reported
Cycle 4 Day 1: Post Dose

Analysis denominator · Participants

GroupSource count
Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL60
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL0.2560.118Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.08
        value
        0.590
    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
        0.248
        value
        0.229
    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
        0.213
        value
        0.316
    denoms
    1. counts
      1. group Id
        OG000
        value
        91
      units
      Participants
    title
    Cycle 2 Day 1: Post Dose
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.118
        value
        0.186
    denoms
    1. counts
      1. group Id
        OG000
        value
        61
      units
      Participants
    title
    Cycle 4 Day 1: Pre-dose
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.118
        value
        0.256
    denoms
    1. counts
      1. group Id
        OG000
        value
        60
      units
      Participants
    title
    Cycle 4 Day 1: Post Dose
denoms
  1. counts
    1. group Id
      OG000
      value
      103
    units
    Participants
description
PK of one pola-related analytes: Unconjugated MMAE 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 (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 1 and 3 Day 8 and 15; Cycle 2, 3 and 4 Day 1: pre-dose and post dose
title
Arm G+H (Phase II NF Cohorts): Plasma Concentration of Polatuzumab Vedotin Analyte: Unconjugated MMAE
type
SECONDARY
unit Of Measure
ng/mL

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice