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NCT01466881 · OUTCOME

Objective Response Rate (Complete Responses (CR) + Partial Responses (PR))

Alisertib in Treating Patients With Relapsed or Refractory Peripheral T-Cell Non-Hodgkin Lymphoma · Source last updated 2016-03-10

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Up to 1 year after registration

What was measured

Objective disease status is evaluated according to the 2007 revised Cheson et al. criteria. Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. Partial Response(PR) is a 50% decrease in the SPD for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.

Analysis population: All eligible patients who started treatment were included in assessing response estimates.

Groups in this outcome

MLN8237

Patients receive MLN8237 (alisertib) PO BID on days 1-7. Treatment repeats every 21 days for 17 courses in the absence of disease progression or unacceptable toxicity

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

Analysis denominator · Participants

GroupSource count
MLN823737

Reported measurements

Complete Response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MLN82372Not reportedNot reportedNot reportedNot reported
Partial Response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MLN82377Not reportedNot reportedNot reportedNot reported
No response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MLN823728Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Complete Response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        7
    title
    Partial Response
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        28
    title
    No response
denoms
  1. counts
    1. group Id
      OG000
      value
      37
    units
    Participants
description
Objective disease status is evaluated according to the 2007 revised Cheson et al. criteria. Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. Partial Response(PR) is a 50% decrease in the SPD for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.
groups
  1. description
    Patients receive MLN8237 (alisertib) PO BID on days 1-7. Treatment repeats every 21 days for 17 courses in the absence of disease progression or unacceptable toxicity
    id
    OG000
    title
    MLN8237
param Type
NUMBER
population Description
All eligible patients who started treatment were included in assessing response estimates.
reporting Status
POSTED
time Frame
Up to 1 year after registration
title
Objective Response Rate (Complete Responses (CR) + Partial Responses (PR))
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice