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NCT02393859 · OUTCOME

Number of Participants With Anti-Blinatumomab Antibodies Postbaseline (Blinatumomab Arm Only)

Phase 3 Trial of Blinatumomab vs Standard Chemotherapy in Pediatric Subjects With HIgh-Risk (HR) First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL) · Source last updated 2026-06-26

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
Day 1 to Day 29.

What was measured

Participants receiving blinatumomab had blood samples analyzed for binding antibodies. Samples testing positive for binding antibodies were also tested for neutralizing antibodies. Participants who were binding antibody-positive or neutralizing antibody-positive post-baseline with a negative or no result at baseline are presented.

Analysis population: Safety Analysis Set: participants who received protocol-specified therapy analyzed according to the treatment they received. Participants in the blinatumumab arm with a post-baseline result.

Groups in this outcome

Blinatumomab

One 4-week cycle of blinatumomab 15 μg/m\^2/day as a continuous intravenous infusion (CIVI).

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

Analysis denominator · Participants

GroupSource count
Blinatumomab52

Reported measurements

Binding Antibody Positive
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Blinatumomab0Not reportedNot reportedNot reportedNot reported
Neutralizing Antibody Positive
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Blinatumomab0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Binding Antibody Positive
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Neutralizing Antibody Positive
denoms
  1. counts
    1. group Id
      OG000
      value
      52
    units
    Participants
description
Participants receiving blinatumomab had blood samples analyzed for binding antibodies. Samples testing positive for binding antibodies were also tested for neutralizing antibodies. Participants who were binding antibody-positive or neutralizing antibody-positive post-baseline with a negative or no result at baseline are presented.
groups
  1. description
    One 4-week cycle of blinatumomab 15 μg/m\^2/day as a continuous intravenous infusion (CIVI).
    id
    OG000
    title
    Blinatumomab
param Type
NUMBER
population Description
Safety Analysis Set: participants who received protocol-specified therapy analyzed according to the treatment they received. Participants in the blinatumumab arm with a post-baseline result.
reporting Status
POSTED
time Frame
Day 1 to Day 29.
title
Number of Participants With Anti-Blinatumomab Antibodies Postbaseline (Blinatumomab Arm Only)
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice