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NCT02257567 · OUTCOME

Phase Ib: Cmax of Polatuzumab Vedotin, Bendamustine, and Rituximab in Cohort 1a

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 in Cohort 1a (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 Rituximab.

Groups in this outcome

Cohort 1a (Phase Ib Safety Run-In): Pola+BR 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 rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.

Cohort 1a (Phase Ib Safety Run-In): Pola+BR 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 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
Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL6
Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL6

Reported measurements

acMMAE: Cycle 1

Analysis denominator · Participants

GroupSource count
Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL6
Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL6
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL676176Not reportedNot reportedNot reported
Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL634158Not reportedNot reportedNot reported
acMMAE: Cycle 2

Analysis denominator · Participants

GroupSource count
Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL6
Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL6
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL697129Not reportedNot reportedNot reported
Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL694138Not reportedNot reportedNot reported
acMMAE: Cycle 4

Analysis denominator · Participants

GroupSource count
Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL5
Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL3
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL763159Not reportedNot reportedNot reported
Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL759107Not reportedNot reportedNot reported
Total Ab: Cycle 1

Analysis denominator · Participants

GroupSource count
Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL6
Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL6
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL34.38.57Not reportedNot reportedNot reported
Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL37.69.42Not reportedNot reportedNot reported
Total Ab: Cycle 2

Analysis denominator · Participants

GroupSource count
Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL6
Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL6
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL36.68.00Not reportedNot reportedNot reported
Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL40.69.46Not reportedNot reportedNot reported
Total Ab: Cycle 4

Analysis denominator · Participants

GroupSource count
Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL5
Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL3
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL41.39.98Not reportedNot reportedNot reported
Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL44.85.06Not reportedNot reportedNot reported
Unconjugated MMAE: Cycle 1

Analysis denominator · Participants

GroupSource count
Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL6
Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL6
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL3.314.00Not reportedNot reportedNot reported
Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL2.211.34Not reportedNot reportedNot reported
Unconjugated MMAE: Cycle 2

Analysis denominator · Participants

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

Analysis denominator · Participants

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

Analysis denominator · Participants

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

Analysis denominator · Participants

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

Analysis denominator · Participants

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

Analysis denominator · Participants

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

Analysis denominator · Participants

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

Analysis denominator · Participants

GroupSource count
Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL0
Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL0
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        176
        value
        676
      2. group Id
        OG001
        spread
        158
        value
        634
    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
        129
        value
        697
      2. group Id
        OG001
        spread
        138
        value
        694
    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
        159
        value
        763
      2. group Id
        OG001
        spread
        107
        value
        759
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        3
      units
      Participants
    title
    acMMAE: Cycle 4
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        8.57
        value
        34.3
      2. group Id
        OG001
        spread
        9.42
        value
        37.6
    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
        8.00
        value
        36.6
      2. group Id
        OG001
        spread
        9.46
        value
        40.6
    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
        9.98
        value
        41.3
      2. group Id
        OG001
        spread
        5.06
        value
        44.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        3
      units
      Participants
    title
    Total Ab: Cycle 4
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.00
        value
        3.31
      2. group Id
        OG001
        spread
        1.34
        value
        2.21
    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 rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.
    id
    OG000
    title
    Cohort 1a (Phase Ib Safety Run-In): Pola+BR 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 rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.
    id
    OG001
    title
    Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL
param Type
MEAN
population Description
PK evaluable population included all the ITT participants in Cohort 1a (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 Rituximab.
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 Rituximab in Cohort 1a
type
SECONDARY
unit Of Measure
ng/mL

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Preserved source evidence · Not medical advice