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NCT03462719 · OUTCOME

Plasma Concentration of Ibrutinib and Venetoclax

A Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) · Source last updated 2026-08-31

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

Measure
MEAN
Unit
Nanograms per milliliter (ng/mL)
Interval / dispersion
Standard Deviation
Time frame
Ibrutinib: Pre-dose-Day 1 of Cycles 2, 3, 5 and 6 (each cycle is defined as 28 days), Venetoclax: Pre-dose-Day 1 of Cycles 5 and 6

What was measured

Plasma concentrations of ibrutinib and venetoclax were determined by validated liquid chromatography-tandem mass spectrometry.

Analysis population: The pharmacokinetics (PK) analysis set is defined as all randomized participants in Treatment Arm A who received at least one dose of ibrutinib and/or venetoclax and had at least one valid blood sample drawn for PK analysis. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this endpoint. Here, "n (number analyzed)" is defined as number of participants analyzed for specified category.

Groups in this outcome

Treatment Arm A (Ibrutinib + Venetoclax)

Participants received ibrutinib 420 milligrams (mg) orally once daily for 3 cycles (each cycle is of 28 days) followed by the combination of ibrutinib 420 mg and venetoclax 400 mg orally once daily for 12 cycles (including a 5-week venetoclax dose ramp up starting in cycle 4). Participants who subsequently developed independent review committee (IRC)-confirmed progressive disease (PD) and had active disease requiring treatment were eligible to participate in the Subsequent Therapy Phase and received single-agent ibrutinib until disease progression or unacceptable toxicity.

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

Analysis denominator · Participants

GroupSource count
Treatment Arm A (Ibrutinib + Venetoclax)79

Reported measurements

Ibrutinib: Pre-dose Day 1 Cycle 2 (Ibrutinib Alone)

Analysis denominator · Participants

GroupSource count
Treatment Arm A (Ibrutinib + Venetoclax)63
Values in Nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment Arm A (Ibrutinib + Venetoclax)5.705.58Not reportedNot reportedNot reported
Ibrutinib: Pre-dose Day 1 Cycle 3 (Ibrutinib Alone)

Analysis denominator · Participants

GroupSource count
Treatment Arm A (Ibrutinib + Venetoclax)59
Values in Nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment Arm A (Ibrutinib + Venetoclax)6.207.78Not reportedNot reportedNot reported
Ibrutinib: Pre-dose Day 1 Cycle 5 (Ibrutinib and Venetoclax)

Analysis denominator · Participants

GroupSource count
Treatment Arm A (Ibrutinib + Venetoclax)65
Values in Nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment Arm A (Ibrutinib + Venetoclax)6.376.71Not reportedNot reportedNot reported
Ibrutinib: Pre-dose Day 1 Cycle 6 (Ibrutinib and Venetoclax)

Analysis denominator · Participants

GroupSource count
Treatment Arm A (Ibrutinib + Venetoclax)60
Values in Nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment Arm A (Ibrutinib + Venetoclax)5.906.74Not reportedNot reportedNot reported
Venetoclax: Pre-dose Day 1 Cycle 5 (Ibrutinib + Venetoclax)

Analysis denominator · Participants

GroupSource count
Treatment Arm A (Ibrutinib + Venetoclax)79
Values in Nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment Arm A (Ibrutinib + Venetoclax)1139959Not reportedNot reportedNot reported
Venetoclax: Pre-dose Day 1 Cycle 6 (Ibrutinib + Venetoclax)

Analysis denominator · Participants

GroupSource count
Treatment Arm A (Ibrutinib + Venetoclax)65
Values in Nanograms per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment Arm A (Ibrutinib + Venetoclax)17651573Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.58
        value
        5.70
    denoms
    1. counts
      1. group Id
        OG000
        value
        63
      units
      Participants
    title
    Ibrutinib: Pre-dose Day 1 Cycle 2 (Ibrutinib Alone)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        7.78
        value
        6.20
    denoms
    1. counts
      1. group Id
        OG000
        value
        59
      units
      Participants
    title
    Ibrutinib: Pre-dose Day 1 Cycle 3 (Ibrutinib Alone)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        6.71
        value
        6.37
    denoms
    1. counts
      1. group Id
        OG000
        value
        65
      units
      Participants
    title
    Ibrutinib: Pre-dose Day 1 Cycle 5 (Ibrutinib and Venetoclax)
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        6.74
        value
        5.90
    denoms
    1. counts
      1. group Id
        OG000
        value
        60
      units
      Participants
    title
    Ibrutinib: Pre-dose Day 1 Cycle 6 (Ibrutinib and Venetoclax)
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        959
        value
        1139
    denoms
    1. counts
      1. group Id
        OG000
        value
        79
      units
      Participants
    title
    Venetoclax: Pre-dose Day 1 Cycle 5 (Ibrutinib + Venetoclax)
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        1573
        value
        1765
    denoms
    1. counts
      1. group Id
        OG000
        value
        65
      units
      Participants
    title
    Venetoclax: Pre-dose Day 1 Cycle 6 (Ibrutinib + Venetoclax)
denoms
  1. counts
    1. group Id
      OG000
      value
      79
    units
    Participants
description
Plasma concentrations of ibrutinib and venetoclax were determined by validated liquid chromatography-tandem mass spectrometry.
dispersion Type
Standard Deviation
groups
  1. description
    Participants received ibrutinib 420 milligrams (mg) orally once daily for 3 cycles (each cycle is of 28 days) followed by the combination of ibrutinib 420 mg and venetoclax 400 mg orally once daily for 12 cycles (including a 5-week venetoclax dose ramp up starting in cycle 4). Participants who subsequently developed independent review committee (IRC)-confirmed progressive disease (PD) and had active disease requiring treatment were eligible to participate in the Subsequent Therapy Phase and received single-agent ibrutinib until disease progression or unacceptable toxicity.
    id
    OG000
    title
    Treatment Arm A (Ibrutinib + Venetoclax)
param Type
MEAN
population Description
The pharmacokinetics (PK) analysis set is defined as all randomized participants in Treatment Arm A who received at least one dose of ibrutinib and/or venetoclax and had at least one valid blood sample drawn for PK analysis. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this endpoint. Here, "n (number analyzed)" is defined as number of participants analyzed for specified category.
reporting Status
POSTED
time Frame
Ibrutinib: Pre-dose-Day 1 of Cycles 2, 3, 5 and 6 (each cycle is defined as 28 days), Venetoclax: Pre-dose-Day 1 of Cycles 5 and 6
title
Plasma Concentration of Ibrutinib and Venetoclax
type
SECONDARY
unit Of Measure
Nanograms per milliliter (ng/mL)

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Preserved source evidence · Not medical advice