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NCT01456039 · OUTCOME

Percentage of PTCL Participants With the Best Response in Accordance With the Modified 2007 International Workshop Response Criteria as Assessed by IER

A Japanese Phase 1/2 Study to Assess the Efficacy, Safety and Pharmacokinetics of Romidepsin in Patients With Peripheral T-cell Lymphoma (PTCL) · Source last updated 2019-02-11

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
95% Confidence Interval
Time frame
Tumor assessments performed every 2 months; median follow-up time was 100 days; up to the data cut-off of 28 July 2015

What was measured

Objective disease response in PTCL was defined as achieving a CR or PR based on the Modified 2007 IWC. A CR = a complete disappearance of all disease; lymph node mass regression to normal size on computerized tomography (CT) scan or negative on positron emission tomography (PET); non-palpable splenic and disappearance of liver nodules; infiltrate cleared on repeat bone marrow (BM), immunohistochemistry negative. PR = a reduction of measurable lesions; ≥ 50% decrease in sum of the products of the greatest diameters (SPD) of up to 6 largest dominant masses, no enlargement in size of other nodes; ≥ 50% decrease in SPD and no increase in liver or spleen.

Analysis population: Intent to treat population for participants with PTCL who received at least one dose of romidepsin

Groups in this outcome

Phase 1: Cohort 1: Romidepsin 9mg/m^2

Romidepsin 9mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle

Phase 1: Cohort 2: Romidepsin 14mg/m^2

Romidepsin 14mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.

Phase 2: Romidepsin 14mg/m^2

Romidepsin 14mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.

Total: Romidepsin 14mg/m^2

Romidepsin 14mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.

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

Analysis denominator · Participants

GroupSource count
Phase 1: Cohort 1: Romidepsin 9mg/m^22
Phase 1: Cohort 2: Romidepsin 14mg/m^26
Phase 2: Romidepsin 14mg/m^240
Total: Romidepsin 14mg/m^246

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 1: Cohort 1: Romidepsin 9mg/m^20Not reported0.0000.000Not reported
Phase 1: Cohort 2: Romidepsin 14mg/m^216.7Not reported0.00046.487Not reported
Phase 2: Romidepsin 14mg/m^242.5Not reported27.18057.820Not reported
Total: Romidepsin 14mg/m^239.1Not reported25.02753.234Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.000
        upper Limit
        0.000
        value
        0
      2. group Id
        OG001
        lower Limit
        0.000
        upper Limit
        46.487
        value
        16.7
      3. group Id
        OG002
        lower Limit
        27.180
        upper Limit
        57.820
        value
        42.5
      4. group Id
        OG003
        lower Limit
        25.027
        upper Limit
        53.234
        value
        39.1
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      40
    4. group Id
      OG003
      value
      46
    units
    Participants
description
Objective disease response in PTCL was defined as achieving a CR or PR based on the Modified 2007 IWC. A CR = a complete disappearance of all disease; lymph node mass regression to normal size on computerized tomography (CT) scan or negative on positron emission tomography (PET); non-palpable splenic and disappearance of liver nodules; infiltrate cleared on repeat bone marrow (BM), immunohistochemistry negative. PR = a reduction of measurable lesions; ≥ 50% decrease in sum of the products of the greatest diameters (SPD) of up to 6 largest dominant masses, no enlargement in size of other nodes; ≥ 50% decrease in SPD and no increase in liver or spleen.
dispersion Type
95% Confidence Interval
groups
  1. description
    Romidepsin 9mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
    id
    OG000
    title
    Phase 1: Cohort 1: Romidepsin 9mg/m^2
  2. description
    Romidepsin 14mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
    id
    OG001
    title
    Phase 1: Cohort 2: Romidepsin 14mg/m^2
  3. description
    Romidepsin 14mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
    id
    OG002
    title
    Phase 2: Romidepsin 14mg/m^2
  4. description
    Romidepsin 14mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
    id
    OG003
    title
    Total: Romidepsin 14mg/m^2
param Type
NUMBER
population Description
Intent to treat population for participants with PTCL who received at least one dose of romidepsin
reporting Status
POSTED
time Frame
Tumor assessments performed every 2 months; median follow-up time was 100 days; up to the data cut-off of 28 July 2015
title
Percentage of PTCL Participants With the Best Response in Accordance With the Modified 2007 International Workshop Response Criteria as Assessed by IER
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice