Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02257567 · OUTCOME

Phase II: Cmax of Polatuzumab Vedotin, Bendamustine, and Rituximab in Arms A and C

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; Cycle 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 Arms A and C 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 timepoints.

Groups in this outcome

Arm A (Phase II Randomization): 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.

Arm C (Phase II Randomization): 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
Arm A (Phase II Randomization): Pola+BR in FL36
Arm C (Phase II Randomization): Pola+BR in DLBCL35

Reported measurements

acMMAE: Cycle 1

Analysis denominator · Participants

GroupSource count
Arm A (Phase II Randomization): Pola+BR in FL36
Arm C (Phase II Randomization): Pola+BR in DLBCL35
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm A (Phase II Randomization): Pola+BR in FL622194Not reportedNot reportedNot reported
Arm C (Phase II Randomization): Pola+BR in DLBCL661149Not reportedNot reportedNot reported
acMMAE: Cycle 4

Analysis denominator · Participants

GroupSource count
Arm A (Phase II Randomization): Pola+BR in FL29
Arm C (Phase II Randomization): Pola+BR in DLBCL23
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm A (Phase II Randomization): Pola+BR in FL703150Not reportedNot reportedNot reported
Arm C (Phase II Randomization): Pola+BR in DLBCL659135Not reportedNot reportedNot reported
Total Ab: Cycle 1

Analysis denominator · Participants

GroupSource count
Arm A (Phase II Randomization): Pola+BR in FL36
Arm C (Phase II Randomization): Pola+BR in DLBCL35
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm A (Phase II Randomization): Pola+BR in FL36.79.54Not reportedNot reportedNot reported
Arm C (Phase II Randomization): Pola+BR in DLBCL35.78.50Not reportedNot reportedNot reported
Total Ab: Cycle 4

Analysis denominator · Participants

GroupSource count
Arm A (Phase II Randomization): Pola+BR in FL31
Arm C (Phase II Randomization): Pola+BR in DLBCL23
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm A (Phase II Randomization): Pola+BR in FL46.111.4Not reportedNot reportedNot reported
Arm C (Phase II Randomization): Pola+BR in DLBCL41.48.29Not reportedNot reportedNot reported
Unconjugated MMAE: Cycle 1

Analysis denominator · Participants

GroupSource count
Arm A (Phase II Randomization): Pola+BR in FL0
Arm C (Phase II Randomization): Pola+BR in DLBCL0
Unconjugated MMAE: Cycle 4

Analysis denominator · Participants

GroupSource count
Arm A (Phase II Randomization): Pola+BR in FL0
Arm C (Phase II Randomization): Pola+BR in DLBCL0
Bendamustine: Cycle 1

Analysis denominator · Participants

GroupSource count
Arm A (Phase II Randomization): Pola+BR in FL34
Arm C (Phase II Randomization): Pola+BR in DLBCL33
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm A (Phase II Randomization): Pola+BR in FL3.572.06Not reportedNot reportedNot reported
Arm C (Phase II Randomization): Pola+BR in DLBCL4.232.26Not reportedNot reportedNot reported
Bendamustine: Cycle 4

Analysis denominator · Participants

GroupSource count
Arm A (Phase II Randomization): Pola+BR in FL0
Arm C (Phase II Randomization): Pola+BR in DLBCL0
Rituximab: Cycle 1

Analysis denominator · Participants

GroupSource count
Arm A (Phase II Randomization): Pola+BR in FL32
Arm C (Phase II Randomization): Pola+BR in DLBCL34
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm A (Phase II Randomization): Pola+BR in FL18849.2Not reportedNot reportedNot reported
Arm C (Phase II Randomization): Pola+BR in DLBCL19135.9Not reportedNot reportedNot reported
Rituximab: Cycle 4

Analysis denominator · Participants

GroupSource count
Arm A (Phase II Randomization): Pola+BR in FL0
Arm C (Phase II Randomization): Pola+BR in DLBCL0
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        194
        value
        622
      2. group Id
        OG001
        spread
        149
        value
        661
    denoms
    1. counts
      1. group Id
        OG000
        value
        36
      2. group Id
        OG001
        value
        35
      units
      Participants
    title
    acMMAE: Cycle 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        150
        value
        703
      2. group Id
        OG001
        spread
        135
        value
        659
    denoms
    1. counts
      1. group Id
        OG000
        value
        29
      2. group Id
        OG001
        value
        23
      units
      Participants
    title
    acMMAE: Cycle 4
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        9.54
        value
        36.7
      2. group Id
        OG001
        spread
        8.50
        value
        35.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        36
      2. group Id
        OG001
        value
        35
      units
      Participants
    title
    Total Ab: Cycle 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        11.4
        value
        46.1
      2. group Id
        OG001
        spread
        8.29
        value
        41.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        31
      2. group Id
        OG001
        value
        23
      units
      Participants
    title
    Total Ab: Cycle 4
  5. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Unconjugated MMAE: Cycle 1
  6. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Unconjugated MMAE: Cycle 4
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.06
        value
        3.57
      2. group Id
        OG001
        spread
        2.26
        value
        4.23
    denoms
    1. counts
      1. group Id
        OG000
        value
        34
      2. group Id
        OG001
        value
        33
      units
      Participants
    title
    Bendamustine: Cycle 1
  8. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Bendamustine: Cycle 4
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        49.2
        value
        188
      2. group Id
        OG001
        spread
        35.9
        value
        191
    denoms
    1. counts
      1. group Id
        OG000
        value
        32
      2. group Id
        OG001
        value
        34
      units
      Participants
    title
    Rituximab: Cycle 1
  10. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Rituximab: Cycle 4
denoms
  1. counts
    1. group Id
      OG000
      value
      36
    2. group Id
      OG001
      value
      35
    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
    Arm A (Phase II Randomization): 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
    Arm C (Phase II Randomization): Pola+BR in DLBCL
param Type
MEAN
population Description
PK evaluable population included all the ITT participants in Arms A and C 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 timepoints.
reporting Status
POSTED
time Frame
Cycle 1; Cycle 4 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)
title
Phase II: Cmax of Polatuzumab Vedotin, Bendamustine, and Rituximab in Arms A and C
type
SECONDARY
unit Of Measure
ng/mL

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

Preserved source evidence · Not medical advice