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NCT04101331 · OUTCOME

Complete Response Rate, Partial Response Rate and Overall Response Rate Assessed by Independent Review Committee Based on CT

Phase II Study to Assess AFM13 in Patients With R/R CD30-positive T-cell Lymphoma or Transformed Mycosis Fungoides · Source last updated 2024-11-05

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

Measure
NUMBER
Unit
percentage
Interval / dispersion
95% Confidence Interval
Time frame
Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months).

What was measured

Overall response by Computed Tomography (CT) as defined by achieving complete response and/or partial response assessed by an Independent Review Committee (IRC) utilizing the modified Lugano Classification Revised Staging System for malignant lymphoma (Cheson, 2014).

Analysis population: The full analysis set (FAS) followed the intent to treat (ITT) principle and consisted of all subjects who received at least one dose of AFM13.

Groups in this outcome

Cohort A

Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).

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

Analysis denominator · Participants

GroupSource count
Cohort A108

Reported measurements

Overall response rate (ORR)
Values in percentage · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort A25.0Not reported17.234.3Not reported
Complete response rate (CR rate)
Values in percentage · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort A7.4Not reported3.314.1Not reported
Partial response rate (PR rate)
Values in percentage · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort A17.6Not reported10.926.1Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Ids
    1. OG000
    non Inferiority Type
    OTHER
    p Value
    0.537
    p Value Comment
    One-sided p-value.
    statistical Comment
    Exact binomial test compares versus a proportion of 0.25.
    statistical Method
    Exact binomial test
Complete source fields
analyses
  1. group Ids
    1. OG000
    non Inferiority Type
    OTHER
    p Value
    0.537
    p Value Comment
    One-sided p-value.
    statistical Comment
    Exact binomial test compares versus a proportion of 0.25.
    statistical Method
    Exact binomial test
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        17.2
        upper Limit
        34.3
        value
        25.0
    title
    Overall response rate (ORR)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.3
        upper Limit
        14.1
        value
        7.4
    title
    Complete response rate (CR rate)
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        10.9
        upper Limit
        26.1
        value
        17.6
    title
    Partial response rate (PR rate)
denoms
  1. counts
    1. group Id
      OG000
      value
      108
    units
    Participants
description
Overall response by Computed Tomography (CT) as defined by achieving complete response and/or partial response assessed by an Independent Review Committee (IRC) utilizing the modified Lugano Classification Revised Staging System for malignant lymphoma (Cheson, 2014).
dispersion Type
95% Confidence Interval
groups
  1. description
    Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).
    id
    OG000
    title
    Cohort A
param Type
NUMBER
population Description
The full analysis set (FAS) followed the intent to treat (ITT) principle and consisted of all subjects who received at least one dose of AFM13.
reporting Status
POSTED
time Frame
Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 46 months).
title
Complete Response Rate, Partial Response Rate and Overall Response Rate Assessed by Independent Review Committee Based on CT
type
SECONDARY
unit Of Measure
percentage

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

Preserved source evidence · Not medical advice