Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02005471 · OUTCOME

Plasma Venetoclax Concentrations

A Study to Evaluate the Benefit of Venetoclax Plus Rituximab Compared With Bendamustine Plus Rituximab in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) · Source last updated 2023-10-17

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

Measure
MEAN
Unit
micrograms per milliliter (mcg/mL)
Interval / dispersion
Standard Deviation
Time frame
Pre-dose (0 hour, anytime before venetoclax administration) and 4 hours post-dose on D1 of Cycles 1 and 4; Cycle length = 28 days

Analysis population: Pharmacokinetic (PK) evaluable population included all participants in the 'Venetoclax + Rituximab' arm who received at least one dose of venetoclax with at least one post-dose PK concentration result available. Here 'Number Analyzed' signifies the number of participants evaluable at specified time point.

Groups in this outcome

Venetoclax + Rituximab Main Study

Participants were initially placed on a venetoclax ramp-up period of 5 weeks and received an initial dose of 20 mg via tablet orally once daily (QD) for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg, orally, QD. Participants continued receiving venetoclax at a dose of 400 mg, orally, QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to PD or 2 years, whichever occurred first, as directed by the investigator, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.

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

Analysis denominator · Participants

GroupSource count
Venetoclax + Rituximab Main Study184

Reported measurements

C1D1, Pre-dose

Analysis denominator · Participants

GroupSource count
Venetoclax + Rituximab Main Study151
Values in micrograms per milliliter (mcg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Venetoclax + Rituximab Main Study0.6260.540Not reportedNot reportedNot reported
C1D1, 4 hours Post-Dose

Analysis denominator · Participants

GroupSource count
Venetoclax + Rituximab Main Study159
Values in micrograms per milliliter (mcg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Venetoclax + Rituximab Main Study1.340.881Not reportedNot reportedNot reported
C4D1, Pre-dose

Analysis denominator · Participants

GroupSource count
Venetoclax + Rituximab Main Study112
Values in micrograms per milliliter (mcg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Venetoclax + Rituximab Main Study0.6810.745Not reportedNot reportedNot reported
C4D1, 4 hours Post-Dose

Analysis denominator · Participants

GroupSource count
Venetoclax + Rituximab Main Study121
Values in micrograms per milliliter (mcg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Venetoclax + Rituximab Main Study1.340.905Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.540
        value
        0.626
    denoms
    1. counts
      1. group Id
        OG000
        value
        151
      units
      Participants
    title
    C1D1, Pre-dose
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.881
        value
        1.34
    denoms
    1. counts
      1. group Id
        OG000
        value
        159
      units
      Participants
    title
    C1D1, 4 hours Post-Dose
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.745
        value
        0.681
    denoms
    1. counts
      1. group Id
        OG000
        value
        112
      units
      Participants
    title
    C4D1, Pre-dose
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.905
        value
        1.34
    denoms
    1. counts
      1. group Id
        OG000
        value
        121
      units
      Participants
    title
    C4D1, 4 hours Post-Dose
denoms
  1. counts
    1. group Id
      OG000
      value
      184
    units
    Participants
dispersion Type
Standard Deviation
groups
  1. description
    Participants were initially placed on a venetoclax ramp-up period of 5 weeks and received an initial dose of 20 mg via tablet orally once daily (QD) for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg, orally, QD. Participants continued receiving venetoclax at a dose of 400 mg, orally, QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to PD or 2 years, whichever occurred first, as directed by the investigator, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.
    id
    OG000
    title
    Venetoclax + Rituximab Main Study
param Type
MEAN
population Description
Pharmacokinetic (PK) evaluable population included all participants in the 'Venetoclax + Rituximab' arm who received at least one dose of venetoclax with at least one post-dose PK concentration result available. Here 'Number Analyzed' signifies the number of participants evaluable at specified time point.
reporting Status
POSTED
time Frame
Pre-dose (0 hour, anytime before venetoclax administration) and 4 hours post-dose on D1 of Cycles 1 and 4; Cycle length = 28 days
title
Plasma Venetoclax Concentrations
type
SECONDARY
unit Of Measure
micrograms per milliliter (mcg/mL)

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

Preserved source evidence · Not medical advice