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NCT01466179 · OUTCOME

Best Response During the Core Study

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
From the first dose of blinatumomab until 30 days after the end of the last infusion during the core study, or until the data cut-off date of 10 October 2013; a maximum of 7.5 months.

What was measured

Complete Remission (CR): * 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 Complete Remission With Partial Hematological Recovery (CRh\*): * bone marrow blasts ≤ 5% * no evidence of disease * partial recovery of peripheral blood counts: * platelets \> 50,000/μL, and * ANC \> 500/μL Blast Free Hypoplastic or Aplastic Bone Marrow: * bone marrow blasts ≤ 5% * no evidence of disease * insufficient recovery of peripheral counts: platelets ≤ 50,000/μL and/or ANC ≤ 500/μL Partial Remission: • bone marrow blasts 6% to 25% with at least a 50% reduction from Baseline.

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

Remission (CR/CRh*)
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Blinatumomab43.4Not reported36.250.8Not reported
Complete Remission
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Blinatumomab35.4Not reported28.642.7Not reported
Complete remission with only partial hematological
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Blinatumomab7.9Not reported4.512.8Not reported
Blast free hypoplastic or aplastic bone marrow
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Blinatumomab9.0Not reported5.314.0Not reported
Partial remission
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Blinatumomab2.6Not reported0.96.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        36.2
        upper Limit
        50.8
        value
        43.4
    title
    Remission (CR/CRh*)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        28.6
        upper Limit
        42.7
        value
        35.4
    title
    Complete Remission
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.5
        upper Limit
        12.8
        value
        7.9
    title
    Complete remission with only partial hematological
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.3
        upper Limit
        14.0
        value
        9.0
    title
    Blast free hypoplastic or aplastic bone marrow
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.9
        upper Limit
        6.1
        value
        2.6
    title
    Partial remission
denoms
  1. counts
    1. group Id
      OG000
      value
      189
    units
    Participants
description
Complete Remission (CR): * 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 Complete Remission With Partial Hematological Recovery (CRh\*): * bone marrow blasts ≤ 5% * no evidence of disease * partial recovery of peripheral blood counts: * platelets \> 50,000/μL, and * ANC \> 500/μL Blast Free Hypoplastic or Aplastic Bone Marrow: * bone marrow blasts ≤ 5% * no evidence of disease * insufficient recovery of peripheral counts: platelets ≤ 50,000/μL and/or ANC ≤ 500/μL Partial Remission: • bone marrow blasts 6% to 25% with at least a 50% reduction from Baseline.
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
From the first dose of blinatumomab until 30 days after the end of the last infusion during the core study, or until the data cut-off date of 10 October 2013; a maximum of 7.5 months.
title
Best Response During the Core Study
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice