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NCT01200758 · OUTCOME

Percentage of Participants With B-Cell Depletion by Cycle for Maintenance Phase

A Study of Rituximab (MabThera) Subcutaneous (SC) Versus Rituximab (MabThera) Intravenous in Participannts With Follicular Non-Hodgkin's Lymphoma · Source last updated 2018-11-27

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
Stage I and II (maintenance): D1 of Cy 9 to 20 (1 Cy=8 weeks) (up to data cutoff of 11 Jan 2016 [up to 6 years])

What was measured

Depletion is defined as a CD19 value \<80 cells/mm\^3.

Analysis population: ITT Population. Here, number of participants analyzed = participants evaluable for the outcome measure. Here "n" = number of participants evaluable for this outcome measure at specified timepoint.

Groups in this outcome

Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)

Eight cycles of rituximab IV infusion (375 mg/m\^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m\^2) once every 8 weeks for 24 months.

Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)

First cycle rituximab IV infusion (375 mg/m\^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.

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

Analysis denominator · Participants

GroupSource count
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)170
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)164

Reported measurements

Cycle 9 Day 1 (n=170, 161)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)99.4Not reportedNot reportedNot reportedNot reported
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)100.0Not reportedNot reportedNot reportedNot reported
Cycle 10 Day 1 (n=165, 164)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)99.4Not reportedNot reportedNot reportedNot reported
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)100.0Not reportedNot reportedNot reportedNot reported
Cycle 11 Day 1 (n=158, 158)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)99.4Not reportedNot reportedNot reportedNot reported
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)100.0Not reportedNot reportedNot reportedNot reported
Cycle 12 Day 1 (n=151, 146)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)100.0Not reportedNot reportedNot reportedNot reported
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)100.0Not reportedNot reportedNot reportedNot reported
Cycle 13 Day 1 (n=149, 143)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)100.0Not reportedNot reportedNot reportedNot reported
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)100.0Not reportedNot reportedNot reportedNot reported
Cycle 14 Day 1 (n=152, 143)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)100.0Not reportedNot reportedNot reportedNot reported
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)100.0Not reportedNot reportedNot reportedNot reported
Cycle 15 Day 1 (n=149, 140)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)100.0Not reportedNot reportedNot reportedNot reported
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)100.0Not reportedNot reportedNot reportedNot reported
Cycle 16 Day 1 (n=142, 141)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)100.0Not reportedNot reportedNot reportedNot reported
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)100.0Not reportedNot reportedNot reportedNot reported
Cycle 17 Day 1 (n=145, 142)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)100.0Not reportedNot reportedNot reportedNot reported
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)100.0Not reportedNot reportedNot reportedNot reported
Cycle 18 Day 1 (n=141, 140)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)100.0Not reportedNot reportedNot reportedNot reported
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)100.0Not reportedNot reportedNot reportedNot reported
Cycle 19 Day 1 (n=140, 138)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)100.0Not reportedNot reportedNot reportedNot reported
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)100.0Not reportedNot reportedNot reportedNot reported
Cycle 20 Day 1 (n=139, 134)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)100.0Not reportedNot reportedNot reportedNot reported
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)100.0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        99.4
      2. group Id
        OG001
        value
        100.0
    title
    Cycle 9 Day 1 (n=170, 161)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        99.4
      2. group Id
        OG001
        value
        100.0
    title
    Cycle 10 Day 1 (n=165, 164)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        99.4
      2. group Id
        OG001
        value
        100.0
    title
    Cycle 11 Day 1 (n=158, 158)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        100.0
      2. group Id
        OG001
        value
        100.0
    title
    Cycle 12 Day 1 (n=151, 146)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        100.0
      2. group Id
        OG001
        value
        100.0
    title
    Cycle 13 Day 1 (n=149, 143)
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        100.0
      2. group Id
        OG001
        value
        100.0
    title
    Cycle 14 Day 1 (n=152, 143)
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        100.0
      2. group Id
        OG001
        value
        100.0
    title
    Cycle 15 Day 1 (n=149, 140)
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        100.0
      2. group Id
        OG001
        value
        100.0
    title
    Cycle 16 Day 1 (n=142, 141)
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        100.0
      2. group Id
        OG001
        value
        100.0
    title
    Cycle 17 Day 1 (n=145, 142)
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        100.0
      2. group Id
        OG001
        value
        100.0
    title
    Cycle 18 Day 1 (n=141, 140)
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        100.0
      2. group Id
        OG001
        value
        100.0
    title
    Cycle 19 Day 1 (n=140, 138)
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        100.0
      2. group Id
        OG001
        value
        100.0
    title
    Cycle 20 Day 1 (n=139, 134)
denoms
  1. counts
    1. group Id
      OG000
      value
      170
    2. group Id
      OG001
      value
      164
    units
    Participants
description
Depletion is defined as a CD19 value \<80 cells/mm\^3.
groups
  1. description
    Eight cycles of rituximab IV infusion (375 mg/m\^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m\^2) once every 8 weeks for 24 months.
    id
    OG000
    title
    Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)
  2. description
    First cycle rituximab IV infusion (375 mg/m\^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
    id
    OG001
    title
    Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)
param Type
NUMBER
population Description
ITT Population. Here, number of participants analyzed = participants evaluable for the outcome measure. Here "n" = number of participants evaluable for this outcome measure at specified timepoint.
reporting Status
POSTED
time Frame
Stage I and II (maintenance): D1 of Cy 9 to 20 (1 Cy=8 weeks) (up to data cutoff of 11 Jan 2016 [up to 6 years])
title
Percentage of Participants With B-Cell Depletion by Cycle for Maintenance Phase
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice