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NCT02257567 · OUTCOME

Phase Ib: Cmax of Polatuzumab Vedotin, Bendamustine, and Obinutuzumab in Cohort 1b

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
Cycles 1, 2 and 4 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)

What was measured

PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.

Analysis population: PK evaluable population included all the ITT participants Cohort 1b (Phase Ib) who received at least one study treatment and who provided suitable PK samples. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints. Due to the sparse sample collection schema Cmax was not evaluated for Bendamustine and Obinutuzumab.

Groups in this outcome

Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL

Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 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 obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.

Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL

Participants with DLBCL received pola, 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 obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 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
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL6
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL6

Reported measurements

acMMAE: Cycle 1

Analysis denominator · Participants

GroupSource count
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL6
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL6
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL738165Not reportedNot reportedNot reported
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL725104Not reportedNot reportedNot reported
acMMAE: Cycle 2

Analysis denominator · Participants

GroupSource count
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL6
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL6
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL816168Not reportedNot reportedNot reported
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL841115Not reportedNot reportedNot reported
acMMAE: Cycle 4

Analysis denominator · Participants

GroupSource count
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL6
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL4
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL749158Not reportedNot reportedNot reported
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL72197.7Not reportedNot reportedNot reported
Total Ab: Cycle 1

Analysis denominator · Participants

GroupSource count
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL6
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL6
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL38.79.84Not reportedNot reportedNot reported
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL34.97.52Not reportedNot reportedNot reported
Total Ab: Cycle 2

Analysis denominator · Participants

GroupSource count
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL6
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL6
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL45.012.1Not reportedNot reportedNot reported
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL43.19.52Not reportedNot reportedNot reported
Total Ab: Cycle 4

Analysis denominator · Participants

GroupSource count
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL6
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL4
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL44.211.2Not reportedNot reportedNot reported
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL48.212.5Not reportedNot reportedNot reported
Unconjugated MMAE: Cycle 1

Analysis denominator · Participants

GroupSource count
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL6
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL6
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL2.171.08Not reportedNot reportedNot reported
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL2.390.492Not reportedNot reportedNot reported
Unconjugated MMAE: Cycle 2

Analysis denominator · Participants

GroupSource count
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL0
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL0
Unconjugated MMAE: Cycle 4

Analysis denominator · Participants

GroupSource count
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL0
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL0
Bendamustine: Cycle 1

Analysis denominator · Participants

GroupSource count
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL0
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL0
Bendamustine: Cycle 2

Analysis denominator · Participants

GroupSource count
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL0
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL0
Bendamustine: Cycle 4

Analysis denominator · Participants

GroupSource count
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL0
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL0
Rituximab: Cycle 1

Analysis denominator · Participants

GroupSource count
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL0
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL0
Rituximab: Cycle 2

Analysis denominator · Participants

GroupSource count
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL0
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL0
Rituximab: Cycle 4

Analysis denominator · Participants

GroupSource count
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL0
Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL0
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        165
        value
        738
      2. group Id
        OG001
        spread
        104
        value
        725
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        6
      units
      Participants
    title
    acMMAE: Cycle 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        168
        value
        816
      2. group Id
        OG001
        spread
        115
        value
        841
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        6
      units
      Participants
    title
    acMMAE: Cycle 2
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        158
        value
        749
      2. group Id
        OG001
        spread
        97.7
        value
        721
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        4
      units
      Participants
    title
    acMMAE: Cycle 4
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        9.84
        value
        38.7
      2. group Id
        OG001
        spread
        7.52
        value
        34.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        6
      units
      Participants
    title
    Total Ab: Cycle 1
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.1
        value
        45.0
      2. group Id
        OG001
        spread
        9.52
        value
        43.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        6
      units
      Participants
    title
    Total Ab: Cycle 2
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        11.2
        value
        44.2
      2. group Id
        OG001
        spread
        12.5
        value
        48.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        4
      units
      Participants
    title
    Total Ab: Cycle 4
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.08
        value
        2.17
      2. group Id
        OG001
        spread
        0.492
        value
        2.39
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        6
      units
      Participants
    title
    Unconjugated MMAE: Cycle 1
  8. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Unconjugated MMAE: Cycle 2
  9. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Unconjugated MMAE: Cycle 4
  10. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Bendamustine: Cycle 1
  11. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Bendamustine: Cycle 2
  12. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Bendamustine: Cycle 4
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      6
    units
    Participants
description
PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.
dispersion Type
Standard Deviation
groups
  1. description
    Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 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 obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
    id
    OG000
    title
    Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL
  2. description
    Participants with DLBCL received pola, 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 obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
    id
    OG001
    title
    Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL
param Type
MEAN
population Description
PK evaluable population included all the ITT participants Cohort 1b (Phase Ib) who received at least one study treatment and who provided suitable PK samples. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints. Due to the sparse sample collection schema Cmax was not evaluated for Bendamustine and Obinutuzumab.
reporting Status
POSTED
time Frame
Cycles 1, 2 and 4 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)
title
Phase Ib: Cmax of Polatuzumab Vedotin, Bendamustine, and Obinutuzumab in Cohort 1b
type
SECONDARY
unit Of Measure
ng/mL

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