Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01471782 · OUTCOME

Number of Participants Who Developed Anti-blinatumomab Antibodies

Clinical Study With Blinatumomab in Pediatric and Adolescent Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia · Source last updated 2017-02-08

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
Predose up until 30 days after last dose of study medication; median treatment duration was 28 days.

What was measured

Antibodies to blinatumomab were detected using an electrochemiluminescence (ECL)-based assay.

Analysis population: Full analysis set

Groups in this outcome

Phase 1: Blinatumomab 5 µg/m²/Day

Blinatumomab was administered as a continuous intravenous (cIV) infusion at a constant daily flow rate of 5 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.

Phase 1: Blinatumomab 15 µg/m²/Day

Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.

Phase 1: Blinatumomab 30 µg/m²/Day

Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.

Phase 1: Blinatumomab 15/30 µg/m²/Day

Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day for the first week of cycle 1 and then at 30 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 30 µg/m²/day for up to five cycles of treatment.

Phase 1: Blinatumomab 5/15 µg/m²/Day

Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.

Phase 2: Blinatumomab 5/15 µg/m²/Day

Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.

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

Analysis denominator · Participants

GroupSource count
Phase 1: Blinatumomab 5 µg/m²/Day5
Phase 1: Blinatumomab 15 µg/m²/Day7
Phase 1: Blinatumomab 30 µg/m²/Day5
Phase 1: Blinatumomab 15/30 µg/m²/Day6
Phase 1: Blinatumomab 5/15 µg/m²/Day26
Phase 2: Blinatumomab 5/15 µg/m²/Day44

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Blinatumomab 5 µg/m²/Day0Not reportedNot reportedNot reportedNot reported
Phase 1: Blinatumomab 15 µg/m²/Day0Not reportedNot reportedNot reportedNot reported
Phase 1: Blinatumomab 30 µg/m²/Day0Not reportedNot reportedNot reportedNot reported
Phase 1: Blinatumomab 15/30 µg/m²/Day0Not reportedNot reportedNot reportedNot reported
Phase 1: Blinatumomab 5/15 µg/m²/Day0Not reportedNot reportedNot reportedNot reported
Phase 2: Blinatumomab 5/15 µg/m²/Day0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    2. group Id
      OG001
      value
      7
    3. group Id
      OG002
      value
      5
    4. group Id
      OG003
      value
      6
    5. group Id
      OG004
      value
      26
    6. group Id
      OG005
      value
      44
    units
    Participants
description
Antibodies to blinatumomab were detected using an electrochemiluminescence (ECL)-based assay.
groups
  1. description
    Blinatumomab was administered as a continuous intravenous (cIV) infusion at a constant daily flow rate of 5 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
    id
    OG000
    title
    Phase 1: Blinatumomab 5 µg/m²/Day
  2. description
    Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
    id
    OG001
    title
    Phase 1: Blinatumomab 15 µg/m²/Day
  3. description
    Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
    id
    OG002
    title
    Phase 1: Blinatumomab 30 µg/m²/Day
  4. description
    Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day for the first week of cycle 1 and then at 30 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 30 µg/m²/day for up to five cycles of treatment.
    id
    OG003
    title
    Phase 1: Blinatumomab 15/30 µg/m²/Day
  5. description
    Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
    id
    OG004
    title
    Phase 1: Blinatumomab 5/15 µg/m²/Day
  6. description
    Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
    id
    OG005
    title
    Phase 2: Blinatumomab 5/15 µg/m²/Day
param Type
NUMBER
population Description
Full analysis set
reporting Status
POSTED
time Frame
Predose up until 30 days after last dose of study medication; median treatment duration was 28 days.
title
Number of Participants Who Developed Anti-blinatumomab Antibodies
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice