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NCT01871727 · OUTCOME

Main Study Part: Percentage of Participants Testing Positive for Anti-E7777 and Anti-IL-2 Antibodies

A Trial of E7777 in Persistent and Recurrent Cutaneous T-Cell Lymphoma · Source last updated 2024-11-13

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
Not reported
Time frame
Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1

What was measured

Immunogenicity was assessed by determining the anti-E7777 and anti-IL-2 antibodies in serum using validated methods. Percentage of participants testing positive for Anti-E7777 and Anti-IL-2 antibodies were reported.

Analysis population: Main Study Part PK Analysis Set included all participants from whom at least one quantifiable concentration of E7777 was observed at 9 mcg/kg dose (both Main Study and Lead-In).

Groups in this outcome

Main Study Part: E7777 9 mcg/kg

Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part and in Main study part and were presented together here, as planned.

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

Analysis denominator · Participants

GroupSource count
Main Study Part: E7777 9 mcg/kg94

Reported measurements

Cycle 1 Day 1 (Anti-E7777 Antibodies)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Part: E7777 9 mcg/kg85.7Not reportedNot reportedNot reportedNot reported
Cycle 2 Day 1 (Anti-E7777 Antibodies)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Part: E7777 9 mcg/kg91.7Not reportedNot reportedNot reportedNot reported
Cycle 3 Day 1 (Anti-E7777 Antibodies)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Part: E7777 9 mcg/kg95.7Not reportedNot reportedNot reportedNot reported
Cycle 1 Day 1 (Anti-IL-2 Antibodies)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Part: E7777 9 mcg/kg5.5Not reportedNot reportedNot reportedNot reported
Cycle 2 Day 1 (Anti-IL-2 Antibodies)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Part: E7777 9 mcg/kg52.3Not reportedNot reportedNot reportedNot reported
Cycle 3 Day 1 (Anti-IL-2 Antibodies)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Part: E7777 9 mcg/kg88.6Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        85.7
    title
    Cycle 1 Day 1 (Anti-E7777 Antibodies)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        91.7
    title
    Cycle 2 Day 1 (Anti-E7777 Antibodies)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        95.7
    title
    Cycle 3 Day 1 (Anti-E7777 Antibodies)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        5.5
    title
    Cycle 1 Day 1 (Anti-IL-2 Antibodies)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        52.3
    title
    Cycle 2 Day 1 (Anti-IL-2 Antibodies)
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        88.6
    title
    Cycle 3 Day 1 (Anti-IL-2 Antibodies)
denoms
  1. counts
    1. group Id
      OG000
      value
      94
    units
    Participants
description
Immunogenicity was assessed by determining the anti-E7777 and anti-IL-2 antibodies in serum using validated methods. Percentage of participants testing positive for Anti-E7777 and Anti-IL-2 antibodies were reported.
groups
  1. description
    Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part and in Main study part and were presented together here, as planned.
    id
    OG000
    title
    Main Study Part: E7777 9 mcg/kg
param Type
NUMBER
population Description
Main Study Part PK Analysis Set included all participants from whom at least one quantifiable concentration of E7777 was observed at 9 mcg/kg dose (both Main Study and Lead-In).
reporting Status
POSTED
time Frame
Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1
title
Main Study Part: Percentage of Participants Testing Positive for Anti-E7777 and Anti-IL-2 Antibodies
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice