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NCT00075946 · OUTCOME

Time to First Cytotoxic Therapy (TTFC)

Rituximab in Treating Patients With Low Tumor Burden Indolent Non-Hodgkin's Lymphoma · Source last updated 2024-02-01

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

Measure
NUMBER
Unit
probability
Interval / dispersion
95% Confidence Interval
Time frame
Assessed every 13 weeks until rituximab failure observed or August 2013, whichever occurred first.

What was measured

TTFC is defined as the time from randomization to the time of first cytotoxic therapy (chemo and radio therapy), and censored as last follow-up time if no cytotoxic therapy has been used. Since median TTFC was not reached in 3 out of the 4 groups, 3-year TTFC was reported which was defined as the probability of not starting first cytotoxic therapy at 3 years.

Analysis population: Patients who were correctly randomized to one of the two maintenance arms.

Groups in this outcome

Rituximab Retreatment: Follicular Patients

Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.

Rituximab Scheduled: Follicular Patients

Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.

Rituximab Retreatment: Non-Follicular Patients

Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.

Rituximab Scheduled: Non-Follicular Patients

Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.

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

Analysis denominator · Participants

GroupSource count
Rituximab Retreatment: Follicular Patients143
Rituximab Scheduled: Follicular Patients146
Rituximab Retreatment: Non-Follicular Patients23
Rituximab Scheduled: Non-Follicular Patients29

Reported measurements

Source class 1
Values in probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Rituximab Retreatment: Follicular Patients0.84Not reported0.780.90Not reported
Rituximab Scheduled: Follicular Patients0.95Not reported0.910.99Not reported
Rituximab Retreatment: Non-Follicular Patients0.72Not reported0.550.94Not reported
Rituximab Scheduled: Non-Follicular Patients1Not reported11Not reported

Source statistical analyses

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

  1. ci Lower Limit
    1.45
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    7.13
    estimate Comment
    Hazard ratio is for Rituximab Retreatment Arm/Rituximab Scheduled Arm in follicular patients.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.002
    param Type
    Hazard Ratio (HR)
    param Value
    3.21
    statistical Method
    Log Rank
  2. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG002
    2. OG003
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0002
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    1.45
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    7.13
    estimate Comment
    Hazard ratio is for Rituximab Retreatment Arm/Rituximab Scheduled Arm in follicular patients.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.002
    param Type
    Hazard Ratio (HR)
    param Value
    3.21
    statistical Method
    Log Rank
  2. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG002
    2. OG003
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0002
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.78
        upper Limit
        0.90
        value
        0.84
      2. group Id
        OG001
        lower Limit
        0.91
        upper Limit
        0.99
        value
        0.95
      3. group Id
        OG002
        lower Limit
        0.55
        upper Limit
        0.94
        value
        0.72
      4. group Id
        OG003
        lower Limit
        1
        upper Limit
        1
        value
        1
denoms
  1. counts
    1. group Id
      OG000
      value
      143
    2. group Id
      OG001
      value
      146
    3. group Id
      OG002
      value
      23
    4. group Id
      OG003
      value
      29
    units
    Participants
description
TTFC is defined as the time from randomization to the time of first cytotoxic therapy (chemo and radio therapy), and censored as last follow-up time if no cytotoxic therapy has been used. Since median TTFC was not reached in 3 out of the 4 groups, 3-year TTFC was reported which was defined as the probability of not starting first cytotoxic therapy at 3 years.
dispersion Type
95% Confidence Interval
groups
  1. description
    Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
    id
    OG000
    title
    Rituximab Retreatment: Follicular Patients
  2. description
    Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
    id
    OG001
    title
    Rituximab Scheduled: Follicular Patients
  3. description
    Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
    id
    OG002
    title
    Rituximab Retreatment: Non-Follicular Patients
  4. description
    Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
    id
    OG003
    title
    Rituximab Scheduled: Non-Follicular Patients
param Type
NUMBER
population Description
Patients who were correctly randomized to one of the two maintenance arms.
reporting Status
POSTED
time Frame
Assessed every 13 weeks until rituximab failure observed or August 2013, whichever occurred first.
title
Time to First Cytotoxic Therapy (TTFC)
type
SECONDARY
unit Of Measure
probability

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

Preserved source evidence · Independent clinical review pending · Not medical advice