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NCT01841021 · OUTCOME

Overall Response Rate (ORR)

Pilot Study of Brentuximab Vedotin in Relapsed/Refractory Peripheral T-Cell Lymphoma Expressing CD30 · Source last updated 2017-01-19

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
Up to 24 months post treatment

What was measured

ORR: The proportion of patients with complete response (CR) and partial response (PR). Follow-up assessments after cycle 16 to be done every 12 weeks for up to 24 months. Restaging imaging computed tomography (CT) scans to be repeated 12 and 24 months from the beginning of the follow-up period. Objective disease response (CR and PR) defined according to the modified 2007 International Working Group (IWG) response criteria for non-Hodgkin lymphomas (NHL). CR = Disappearance of all evidence of disease; PR = Regression of measurable disease and no new sites.

Analysis population: All participants.

Groups in this outcome

Brentuximab Vedotin Treatment

Brentuximab vedotin will be given intravenously with a dose of 1.8 mg/kg every 21 days, over 30 minutes for 16 cycles in the clinic.

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

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin Treatment1

Reported measurements

Source class 1

Participants with Complete Response

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin Treatment0Not reportedNot reportedNot reportedNot reported

Participants with Partial Response

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin Treatment0Not reportedNot reportedNot reportedNot reported

Participants with Stable Disease

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin Treatment1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      title
      Participants with Complete Response
    2. measurements
      1. group Id
        OG000
        value
        0
      title
      Participants with Partial Response
    3. measurements
      1. group Id
        OG000
        value
        1
      title
      Participants with Stable Disease
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    units
    Participants
description
ORR: The proportion of patients with complete response (CR) and partial response (PR). Follow-up assessments after cycle 16 to be done every 12 weeks for up to 24 months. Restaging imaging computed tomography (CT) scans to be repeated 12 and 24 months from the beginning of the follow-up period. Objective disease response (CR and PR) defined according to the modified 2007 International Working Group (IWG) response criteria for non-Hodgkin lymphomas (NHL). CR = Disappearance of all evidence of disease; PR = Regression of measurable disease and no new sites.
groups
  1. description
    Brentuximab vedotin will be given intravenously with a dose of 1.8 mg/kg every 21 days, over 30 minutes for 16 cycles in the clinic.
    id
    OG000
    title
    Brentuximab Vedotin Treatment
param Type
COUNT_OF_PARTICIPANTS
population Description
All participants.
reporting Status
POSTED
time Frame
Up to 24 months post treatment
title
Overall Response Rate (ORR)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice