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NCT01207388 · OUTCOME

Time to Hematological Relapse

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
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Until the data cut-off date of 05 August 2015; median time on study was 18.3 months.

What was measured

Time to hematological relapse was measured from the start of treatment with blinatumomab until hematological or extramedullary relapse. Participants who died or received HSCT or post-blinatumomab chemotherapy after treatment with blinatumomab were censored at their last hematological assessment prior to death or HSCT or post-blinatumomab chemotherapy (whichever occurred first).

Analysis population: Full analysis set participants who were in hematological complete remission at treatment start, excluding Philadelphia-positive participants.

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
Blinatumomab110

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
BlinatumomabNANot reported7.1NAData not estimable due to the low number of events
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Data not estimable due to the low number of events
        group Id
        OG000
        lower Limit
        7.1
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      110
    units
    Participants
description
Time to hematological relapse was measured from the start of treatment with blinatumomab until hematological or extramedullary relapse. Participants who died or received HSCT or post-blinatumomab chemotherapy after treatment with blinatumomab were censored at their last hematological assessment prior to death or HSCT or post-blinatumomab chemotherapy (whichever occurred first).
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
MEDIAN
population Description
Full analysis set participants who were in hematological complete remission at treatment start, excluding Philadelphia-positive participants.
reporting Status
POSTED
time Frame
Until the data cut-off date of 05 August 2015; median time on study was 18.3 months.
title
Time to Hematological Relapse
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice