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NCT01207388 · OUTCOME

Percentage of Participants With a Minimal Residual Disease (MRD) Response Within the First Treatment Cycle

Confirmatory Phase II Study of Blinatumomab (MT103) in Patients With Minimal Residual Disease of B-precursor Acute Lymphoblastic Leukemia (ALL) · Source last updated 2020-02-10

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
95% Confidence Interval
Time frame
During the first cycle (6 weeks)

What was measured

At the end of the first treatment cycle (Day 29) a bone marrow aspiration/biopsy was performed and evaluated by the central MRD laboratory. Complete MRD response is defined as no polymerase chain reaction (PCR) amplification of individual rearrangements of immunoglobulin (Ig)- or T-cell receptor (TCR)-genes detected after completion of the first cycle.

Analysis population: Primary endpoint full analysis set (Prim EP FAS) included all participants with an Ig TCR PCR MRD assay with the minimum required sensitivity of 1 x 10\^-4 at central lab established at Baseline.

Groups in this outcome

Blinatumomab

Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 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
Blinatumomab113

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Blinatumomab77.0Not reported68.184.4Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        68.1
        upper Limit
        84.4
        value
        77.0
denoms
  1. counts
    1. group Id
      OG000
      value
      113
    units
    Participants
description
At the end of the first treatment cycle (Day 29) a bone marrow aspiration/biopsy was performed and evaluated by the central MRD laboratory. Complete MRD response is defined as no polymerase chain reaction (PCR) amplification of individual rearrangements of immunoglobulin (Ig)- or T-cell receptor (TCR)-genes detected after completion of the first cycle.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.
    id
    OG000
    title
    Blinatumomab
param Type
NUMBER
population Description
Primary endpoint full analysis set (Prim EP FAS) included all participants with an Ig TCR PCR MRD assay with the minimum required sensitivity of 1 x 10\^-4 at central lab established at Baseline.
reporting Status
POSTED
time Frame
During the first cycle (6 weeks)
title
Percentage of Participants With a Minimal Residual Disease (MRD) Response Within the First Treatment Cycle
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice