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NCT01466179 · OUTCOME

Percentage of Participants With a Best Response of Complete Remission Within 2 Cycles of Treatment

Clinical Study With Blinatumomab in Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) · Source last updated 2017-08-18

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
Within the first 2 cycles of treatment, 12 weeks

What was measured

Complete Remission was defined by the following criteria: * bone marrow blasts ≤ 5% * no evidence of disease * full recovery of peripheral blood counts: * platelets \> 100,000/μL, and * absolute neutrophil count (ANC) \> 1,000/μL

Analysis population: Primary analysis set

Groups in this outcome

Blinatumomab

Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 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
Blinatumomab189

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Blinatumomab33.3Not reported26.740.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        26.7
        upper Limit
        40.5
        value
        33.3
denoms
  1. counts
    1. group Id
      OG000
      value
      189
    units
    Participants
description
Complete Remission was defined by the following criteria: * bone marrow blasts ≤ 5% * no evidence of disease * full recovery of peripheral blood counts: * platelets \> 100,000/μL, and * absolute neutrophil count (ANC) \> 1,000/μL
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
    id
    OG000
    title
    Blinatumomab
param Type
NUMBER
population Description
Primary analysis set
reporting Status
POSTED
time Frame
Within the first 2 cycles of treatment, 12 weeks
title
Percentage of Participants With a Best Response of Complete Remission Within 2 Cycles of Treatment
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice