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NCT01812005 · OUTCOME

Progression-free Survival

Alisertib With and Without Rituximab in Treating Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma · Source last updated 2018-06-06

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Time from study entry to the time of progression and/or death, assessed up to 1 year

What was measured

Graphically summarized using the methods of Kaplan and Meier.

Groups in this outcome

Cohort A (Alisertib, Rituximab)

Patients receive alisertib PO BID on days 1-7. Patients unable to achieve CR after course 4 also receive rituximab IV on day 1 of courses 5-12. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. alisertib: Given PO rituximab: Given IV laboratory biomarker analysis: Laboratory correlative studies will be performed

Cohort B (Alisertib, Rituximab)

Patients receive alisertib as in Cohort A. Patients achieving SD or asymptomatic progressive disease after 2 courses also receive rituximab IV on day 1 of courses 3-10. Patients unable to achieve CR by course 4, receive rituximab as in Cohort A. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. alisertib: Given PO rituximab: Given IV laboratory biomarker analysis: Laboratory correlative studies will be performed

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

Analysis denominator · Participants

GroupSource count
Cohort A (Alisertib, Rituximab)1
Cohort B (Alisertib, Rituximab)13

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort A (Alisertib, Rituximab)2Not reportedNANA95% Confidence Interval was incalculable due to an insufficient number of events
Cohort B (Alisertib, Rituximab)1.2Not reported.82.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        95% Confidence Interval was incalculable due to an insufficient number of events
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        2
      2. group Id
        OG001
        lower Limit
        .8
        upper Limit
        2.5
        value
        1.2
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      13
    units
    Participants
description
Graphically summarized using the methods of Kaplan and Meier.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive alisertib PO BID on days 1-7. Patients unable to achieve CR after course 4 also receive rituximab IV on day 1 of courses 5-12. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. alisertib: Given PO rituximab: Given IV laboratory biomarker analysis: Laboratory correlative studies will be performed
    id
    OG000
    title
    Cohort A (Alisertib, Rituximab)
  2. description
    Patients receive alisertib as in Cohort A. Patients achieving SD or asymptomatic progressive disease after 2 courses also receive rituximab IV on day 1 of courses 3-10. Patients unable to achieve CR by course 4, receive rituximab as in Cohort A. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. alisertib: Given PO rituximab: Given IV laboratory biomarker analysis: Laboratory correlative studies will be performed
    id
    OG001
    title
    Cohort B (Alisertib, Rituximab)
param Type
MEDIAN
reporting Status
POSTED
time Frame
Time from study entry to the time of progression and/or death, assessed up to 1 year
title
Progression-free Survival
type
SECONDARY
unit Of Measure
months

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice