Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00274651 · OUTCOME

Objective Response Rate in Patients With Recurrent or Refractory Cutaneous T-cell Lymphoma (CTCL)

A Phase II Clinical Trial of PXD101 in Patients With Recurrent or Refractory Cutaneous and Peripheral T-Cell Lymphomas · Source last updated 2015-07-28

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
throughout the study, or for a maximum of 2 years

What was measured

Tumor response was assessed using Cheson (Cheson 2007) and SWAT criteria. The SWAT score represents the product of the percentage total body surface area (TBSA) involvement of each lesion type (patch, plaque, and tumor or ulceration), multiplied by a weighting factor.

Analysis population: At termination OR was noted in 1/13 patients (Simon Stage 1). With 29 patients in the CTCL arm the demand for expansion to Simon Stage 2 lacked 5 patients and the study was stopped. Instead OR was done as secondary efficacy analysis (ITT and PP (per protocol)) with OR calculated without accounting for Simon design and with 95% confidence intervals

Groups in this outcome

Arm A (CTCL, ITT Population)

CTCL patients will receive 1000 mg/m2 of PXD101 IV belinostat: 1000 mg/m2 for 5 days every 21 days; IV

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

Analysis denominator · Participants

GroupSource count
Arm A (CTCL, ITT Population)29

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A (CTCL, ITT Population)4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        4
denoms
  1. counts
    1. group Id
      OG000
      value
      29
    units
    Participants
description
Tumor response was assessed using Cheson (Cheson 2007) and SWAT criteria. The SWAT score represents the product of the percentage total body surface area (TBSA) involvement of each lesion type (patch, plaque, and tumor or ulceration), multiplied by a weighting factor.
groups
  1. description
    CTCL patients will receive 1000 mg/m2 of PXD101 IV belinostat: 1000 mg/m2 for 5 days every 21 days; IV
    id
    OG000
    title
    Arm A (CTCL, ITT Population)
param Type
NUMBER
population Description
At termination OR was noted in 1/13 patients (Simon Stage 1). With 29 patients in the CTCL arm the demand for expansion to Simon Stage 2 lacked 5 patients and the study was stopped. Instead OR was done as secondary efficacy analysis (ITT and PP (per protocol)) with OR calculated without accounting for Simon design and with 95% confidence intervals
reporting Status
POSTED
time Frame
throughout the study, or for a maximum of 2 years
title
Objective Response Rate in Patients With Recurrent or Refractory Cutaneous T-cell Lymphoma (CTCL)
type
POST_HOC
unit Of Measure
participants

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

Preserved source evidence · Not medical advice