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NCT00425555 · OUTCOME

The Overall Response Rate Using mSWAT Skin Score

Study of Oral LBH589 in Adult Patients With Refractory Cutaneous T-Cell Lymphoma · Source last updated 2021-08-20

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Baseline up to Cycle 12, an average of 12 months

What was measured

Estimate of the response rate of participants with resistant cutaneous T-cell lymphoma (CTCL) treated with Panobinostat using the mSWAT skin scores and 95% CI will be analyzed.

Analysis population: The analysis was performed in FAS population was defined according to the intention-to-treat principle. This population will include all participants enrolled into the study.

Groups in this outcome

Bexarotene Exposed

Participants received Panobinostat 20 mg/day capsule orally, OD on 3 days per week. (Monday, Wednesday and Friday or alternative Day 1, 3 and 5). The treatment duration was not fixed.Participants continued treatment until disease progression or unacceptable toxicity occurred.

Bexarotene Naive

Participants received Panobinostat 20 mg/day capsule orally, OD on 3 days per week. (Monday, Wednesday and Friday or alternative Day 1, 3 and 5). The treatment duration was not fixed. Participants continued treatment until disease progression or unacceptable toxicity occurred.

All Participants

Participants received Panobinostat 20 mg/day capsule orally, OD on 3 days per week. (Monday, Wednesday and Friday or alternative Day 1, 3 and 5). The treatment duration was not fixed. Participants continued treatment until disease progression or unacceptable toxicity occurred.

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

Analysis denominator · Participants

GroupSource count
Bexarotene Exposed79
Bexarotene Naive60
All Participants139

Reported measurements

mSWAT skin response (CR/PR)flare considered as disease progression ( f.i.p ) - Number of responders
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bexarotene Exposed12Not reportedNot reportedNot reportedNot reported
Bexarotene Naive14Not reportedNot reportedNot reportedNot reported
All Participants26Not reportedNot reportedNot reportedNot reported
Physician's Global Assessment- Responder (CR/PR)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bexarotene Exposed15Not reportedNot reportedNot reportedNot reported
Bexarotene Naive18Not reportedNot reportedNot reportedNot reported
All Participants33Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        14
      3. group Id
        OG002
        value
        26
    title
    mSWAT skin response (CR/PR)flare considered as disease progression ( f.i.p ) - Number of responders
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        18
      3. group Id
        OG002
        value
        33
    title
    Physician's Global Assessment- Responder (CR/PR)
denoms
  1. counts
    1. group Id
      OG000
      value
      79
    2. group Id
      OG001
      value
      60
    3. group Id
      OG002
      value
      139
    units
    Participants
description
Estimate of the response rate of participants with resistant cutaneous T-cell lymphoma (CTCL) treated with Panobinostat using the mSWAT skin scores and 95% CI will be analyzed.
groups
  1. description
    Participants received Panobinostat 20 mg/day capsule orally, OD on 3 days per week. (Monday, Wednesday and Friday or alternative Day 1, 3 and 5). The treatment duration was not fixed.Participants continued treatment until disease progression or unacceptable toxicity occurred.
    id
    OG000
    title
    Bexarotene Exposed
  2. description
    Participants received Panobinostat 20 mg/day capsule orally, OD on 3 days per week. (Monday, Wednesday and Friday or alternative Day 1, 3 and 5). The treatment duration was not fixed. Participants continued treatment until disease progression or unacceptable toxicity occurred.
    id
    OG001
    title
    Bexarotene Naive
  3. description
    Participants received Panobinostat 20 mg/day capsule orally, OD on 3 days per week. (Monday, Wednesday and Friday or alternative Day 1, 3 and 5). The treatment duration was not fixed. Participants continued treatment until disease progression or unacceptable toxicity occurred.
    id
    OG002
    title
    All Participants
param Type
COUNT_OF_PARTICIPANTS
population Description
The analysis was performed in FAS population was defined according to the intention-to-treat principle. This population will include all participants enrolled into the study.
reporting Status
POSTED
time Frame
Baseline up to Cycle 12, an average of 12 months
title
The Overall Response Rate Using mSWAT Skin Score
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice