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NCT01812005 · OUTCOME

Overall 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 death due to any cause, assessed up to 1 year

What was measured

Graphically summarized using the methods of Kaplan and Meier.

Analysis population: data was not collected for participants in Cohort A

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)0
Cohort B (Alisertib, Rituximab)13

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort B (Alisertib, Rituximab)3.1Not reported1.727.6Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG001
        lower Limit
        1.7
        upper Limit
        27.6
        value
        3.1
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    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
population Description
data was not collected for participants in Cohort A
reporting Status
POSTED
time Frame
Time from study entry to the time of death due to any cause, assessed up to 1 year
title
Overall Survival
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice