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NCT01292603 · OUTCOME

Part 2: Time to Cmax (Tmax) of Rituximab at Cycle 6

A Study to Compare Subcutaneous Versus Intravenous MabThera (Rituximab) in Combination With Chemotherapy in Patients With Chronic Lymphocytic Leukemia · Source last updated 2018-12-19

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

Measure
GEOMETRIC_MEAN
Unit
days
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Rituximab IV arm: pre-dose, post-dose and on Days 2, 3, 8 ,15, 29 of Cycle 6; Rituximab SC arm: pre-dose, and on Days 2, 3, 8 ,15, 29 of Cycle 6

What was measured

Multiple blood samples were obtained at pre-dose, post-dose and on Days 2, 3, 8 ,15, 29 of Cycle 6 in Rituximab IV arm, and at pre-dose, and on Days 2, 3, 8 ,15, 29 of Cycle 6 in Rituximab SC arm and time to peak plasma concentration of rituximab was determined.

Analysis population: Only participants who entered Part 2 of the study and had PK data available were included in the analysis.

Groups in this outcome

Part 2 : Rituximab IV 500 mg/m^2

Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 0 Cycles 2-6: IV rituximab 500 mg/m\^2 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).

Part 2: Rituximab SC 1600 mg

Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 0 Cycles 2-6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).

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

Analysis denominator · Participants

GroupSource count
Part 2 : Rituximab IV 500 mg/m^258
Part 2: Rituximab SC 1600 mg51

Reported measurements

Source class 1
Values in days · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part 2 : Rituximab IV 500 mg/m^20.22130.84Not reportedNot reportedNot reported
Part 2: Rituximab SC 1600 mg3.1487.62Not reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    11.215
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    19.755
    estimate Comment
    Ratio based on geometric scale and adjusted for the covariate tumor load at baseline.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Adjusted geometric mean ratio
    param Value
    14.884
Complete source fields
analyses
  1. ci Lower Limit
    11.215
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    19.755
    estimate Comment
    Ratio based on geometric scale and adjusted for the covariate tumor load at baseline.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Adjusted geometric mean ratio
    param Value
    14.884
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        130.84
        value
        0.22
      2. group Id
        OG001
        spread
        87.62
        value
        3.14
denoms
  1. counts
    1. group Id
      OG000
      value
      58
    2. group Id
      OG001
      value
      51
    units
    Participants
description
Multiple blood samples were obtained at pre-dose, post-dose and on Days 2, 3, 8 ,15, 29 of Cycle 6 in Rituximab IV arm, and at pre-dose, and on Days 2, 3, 8 ,15, 29 of Cycle 6 in Rituximab SC arm and time to peak plasma concentration of rituximab was determined.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 0 Cycles 2-6: IV rituximab 500 mg/m\^2 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
    id
    OG000
    title
    Part 2 : Rituximab IV 500 mg/m^2
  2. description
    Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 0 Cycles 2-6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
    id
    OG001
    title
    Part 2: Rituximab SC 1600 mg
param Type
GEOMETRIC_MEAN
population Description
Only participants who entered Part 2 of the study and had PK data available were included in the analysis.
reporting Status
POSTED
time Frame
Rituximab IV arm: pre-dose, post-dose and on Days 2, 3, 8 ,15, 29 of Cycle 6; Rituximab SC arm: pre-dose, and on Days 2, 3, 8 ,15, 29 of Cycle 6
title
Part 2: Time to Cmax (Tmax) of Rituximab at Cycle 6
type
SECONDARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice