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NCT02393859 · OUTCOME

Number of Participants With Shifts From Baseline Grade 0 or 1 to Worst Postbaseline Grade 3 or 4 Clinical Chemistry and Hematology Values

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
Up to Day 29 (± 2 days).

What was measured

Severity was graded according to the CTCAE version 4.03: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death. Increases (↑) or decreases (↓) in laboratory value grades (Gr) from baseline (BL) to worst postbaseline (→ PB) grade are presented. NA=not available.

Analysis population: Safety Analysis Set: who received protocol-specified therapy analyzed according to the treatment they received.

Groups in this outcome

HC3 Chemotherapy

One week of treatment with HC3 followed by 3 weeks of no treatment. The standard intensive consolidation chemotherapy course HC3 includes dexamethasone (10 mg/m\^2/day IV on Days 1-6), vincrisitne (1.5 mg/m\^2/day IV on Days 1 and 6), daunorubicin (30 mg/m\^2 IV over 24 hours on Day 5), methotrexate (1 g/m\^2 IV over 36 hours on Day 1), ifosfamide (800 mg/m\^2 IV for 1 hour on Days 2-4), and pegylated \[PEG\]-asparaginase (1000 U/m\^2 IV for 2 hours or IM on Day 6) or, if allergic, erwinia-asparaginase (20,000 units/m\^2 IV or IM every 48 hours for a total of 6 doses).

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
HC3 Chemotherapy52
Blinatumomab54

Reported measurements

Potassium ↑ BL Gr 0 → PB Gr 3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HC3 Chemotherapy0Not reportedNot reportedNot reportedNot reported
Blinatumomab1Not reportedNot reportedNot reportedNot reported
Potassium ↓ BL Gr 0 → PB Gr 3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HC3 Chemotherapy4Not reportedNot reportedNot reportedNot reported
Blinatumomab5Not reportedNot reportedNot reportedNot reported
Potassium ↓ BL Gr 0 → PB Gr 4
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HC3 Chemotherapy1Not reportedNot reportedNot reportedNot reported
Blinatumomab1Not reportedNot reportedNot reportedNot reported
Albumin ↓ BL Gr 0 → PB Gr 3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HC3 Chemotherapy0Not reportedNot reportedNot reportedNot reported
Blinatumomab1Not reportedNot reportedNot reportedNot reported
Calcium ↓ BL Gr 0 → PB Gr 4
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HC3 Chemotherapy1Not reportedNot reportedNot reportedNot reported
Blinatumomab1Not reportedNot reportedNot reportedNot reported
Alanine Aminotransferase ↑ BL Gr 0 → PB Gr 3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HC3 Chemotherapy1Not reportedNot reportedNot reportedNot reported
Blinatumomab0Not reportedNot reportedNot reportedNot reported
Alanine Aminotransferase ↑ BL Gr 1 → PB Gr 3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HC3 Chemotherapy9Not reportedNot reportedNot reportedNot reported
Blinatumomab5Not reportedNot reportedNot reportedNot reported
Aspartate Aminotransferase ↑ BL Gr NA → PB Gr 3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HC3 Chemotherapy1Not reportedNot reportedNot reportedNot reported
Blinatumomab0Not reportedNot reportedNot reportedNot reported
Aspartate Aminotransferase ↑ BL Gr 0 → PB Gr 3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HC3 Chemotherapy2Not reportedNot reportedNot reportedNot reported
Blinatumomab0Not reportedNot reportedNot reportedNot reported
Aspartate Aminotransferase ↑ BL Gr 1 → PB Gr 3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HC3 Chemotherapy5Not reportedNot reportedNot reportedNot reported
Blinatumomab1Not reportedNot reportedNot reportedNot reported
Aspartate Aminotransferase ↑ BL Gr 1 → PB Gr 4
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HC3 Chemotherapy1Not reportedNot reportedNot reportedNot reported
Blinatumomab0Not reportedNot reportedNot reportedNot reported
Gamma-Glutamyl Transferase ↑ BL Gr NA → PB Gr 3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HC3 Chemotherapy0Not reportedNot reportedNot reportedNot reported
Blinatumomab1Not reportedNot reportedNot reportedNot reported
Gamma-Glutamyl Transferase ↑ BL Gr 0 → PB Gr 3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HC3 Chemotherapy3Not reportedNot reportedNot reportedNot reported
Blinatumomab4Not reportedNot reportedNot reportedNot reported
Gamma-Glutamyl Transferase ↑ BL Gr 1 → PB Gr 3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HC3 Chemotherapy6Not reportedNot reportedNot reportedNot reported
Blinatumomab2Not reportedNot reportedNot reportedNot reported
Gamma-Glutamyl Transferase ↑ BL Gr 1 → PB Gr 4
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HC3 Chemotherapy0Not reportedNot reportedNot reportedNot reported
Blinatumomab3Not reportedNot reportedNot reportedNot reported
Amylase ↑ BL Gr 0 → PB Gr 3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HC3 Chemotherapy1Not reportedNot reportedNot reportedNot reported
Blinatumomab1Not reportedNot reportedNot reportedNot reported
Amylase ↑ BL Gr 0 → PB Gr 4
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HC3 Chemotherapy1Not reportedNot reportedNot reportedNot reported
Blinatumomab0Not reportedNot reportedNot reportedNot reported
Amylase ↑ BL Gr 1 → PB Gr 3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HC3 Chemotherapy0Not reportedNot reportedNot reportedNot reported
Blinatumomab1Not reportedNot reportedNot reportedNot reported
Lipase ↑ BL Gr 0 → PB Gr 3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HC3 Chemotherapy3Not reportedNot reportedNot reportedNot reported
Blinatumomab2Not reportedNot reportedNot reportedNot reported
Lipase ↑ BL Gr 0 → PB Gr 4
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HC3 Chemotherapy1Not reportedNot reportedNot reportedNot reported
Blinatumomab2Not reportedNot reportedNot reportedNot reported
Bilirubin ↑ BL Gr 0 → PB Gr 3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HC3 Chemotherapy2Not reportedNot reportedNot reportedNot reported
Blinatumomab1Not reportedNot reportedNot reportedNot reported
Bilirubin ↑ BL Gr 0 → PB Gr 4
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HC3 Chemotherapy1Not reportedNot reportedNot reportedNot reported
Blinatumomab0Not reportedNot reportedNot reportedNot reported
Creatinine ↑ BL Gr NA → PB Gr 3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HC3 Chemotherapy0Not reportedNot reportedNot reportedNot reported
Blinatumomab2Not reportedNot reportedNot reportedNot reported
Hemoglobin ↓ BL Gr 0 → PB Gr 3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HC3 Chemotherapy1Not reportedNot reportedNot reportedNot reported
Blinatumomab0Not reportedNot reportedNot reportedNot reported
Hemoglobin ↓ BL Gr 1 → PB Gr 3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HC3 Chemotherapy4Not reportedNot reportedNot reportedNot reported
Blinatumomab1Not reportedNot reportedNot reportedNot reported
Platelets ↓ BL Gr 0 → PB Gr 3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HC3 Chemotherapy7Not reportedNot reportedNot reportedNot reported
Blinatumomab6Not reportedNot reportedNot reportedNot reported
Platelets ↓ BL Gr 0 → PB Gr 4
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HC3 Chemotherapy13Not reportedNot reportedNot reportedNot reported
Blinatumomab6Not reportedNot reportedNot reportedNot reported
Platelets ↓ BL Gr 1 → PB Gr 3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HC3 Chemotherapy1Not reportedNot reportedNot reportedNot reported
Blinatumomab2Not reportedNot reportedNot reportedNot reported
Platelets ↓ BL Gr 1 → PB Gr 4
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HC3 Chemotherapy8Not reportedNot reportedNot reportedNot reported
Blinatumomab2Not reportedNot reportedNot reportedNot reported
Leukocytes ↓ BL Gr 0 → PB Gr 3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HC3 Chemotherapy2Not reportedNot reportedNot reportedNot reported
Blinatumomab0Not reportedNot reportedNot reportedNot reported
Leukocytes ↓ BL Gr 0 → PB Gr 4
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HC3 Chemotherapy4Not reportedNot reportedNot reportedNot reported
Blinatumomab0Not reportedNot reportedNot reportedNot reported
Leukocytes ↓ BL Gr 1 → PB Gr 3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HC3 Chemotherapy4Not reportedNot reportedNot reportedNot reported
Blinatumomab4Not reportedNot reportedNot reportedNot reported
Leukocytes ↓ BL Gr 1 → PB Gr 4
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HC3 Chemotherapy7Not reportedNot reportedNot reportedNot reported
Blinatumomab1Not reportedNot reportedNot reportedNot reported
Neutrophils ↓ BL Gr 0 → PB Gr 3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HC3 Chemotherapy4Not reportedNot reportedNot reportedNot reported
Blinatumomab11Not reportedNot reportedNot reportedNot reported
Neutrophils ↓ BL Gr 0 → PB Gr 4
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HC3 Chemotherapy23Not reportedNot reportedNot reportedNot reported
Blinatumomab3Not reportedNot reportedNot reportedNot reported
Lymphocytes ↑ BL Gr 0 → PB Gr 3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HC3 Chemotherapy0Not reportedNot reportedNot reportedNot reported
Blinatumomab1Not reportedNot reportedNot reportedNot reported
Lymphocytes ↓ BL Gr 0 → PB Gr 3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HC3 Chemotherapy1Not reportedNot reportedNot reportedNot reported
Blinatumomab3Not reportedNot reportedNot reportedNot reported
Lymphocytes ↓ BL Gr 0 → PB Gr 4
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HC3 Chemotherapy1Not reportedNot reportedNot reportedNot reported
Blinatumomab1Not reportedNot reportedNot reportedNot reported
Lymphocytes ↓ BL Gr 1 → PB Gr 3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HC3 Chemotherapy0Not reportedNot reportedNot reportedNot reported
Blinatumomab1Not reportedNot reportedNot reportedNot reported
Lymphocytes ↓ BL Gr 1 → PB Gr 4
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HC3 Chemotherapy1Not reportedNot reportedNot reportedNot reported
Blinatumomab2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Potassium ↑ BL Gr 0 → PB Gr 3
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        5
    title
    Potassium ↓ BL Gr 0 → PB Gr 3
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
    title
    Potassium ↓ BL Gr 0 → PB Gr 4
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Albumin ↓ BL Gr 0 → PB Gr 3
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
    title
    Calcium ↓ BL Gr 0 → PB Gr 4
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Alanine Aminotransferase ↑ BL Gr 0 → PB Gr 3
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        5
    title
    Alanine Aminotransferase ↑ BL Gr 1 → PB Gr 3
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Aspartate Aminotransferase ↑ BL Gr NA → PB Gr 3
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
    title
    Aspartate Aminotransferase ↑ BL Gr 0 → PB Gr 3
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        1
    title
    Aspartate Aminotransferase ↑ BL Gr 1 → PB Gr 3
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Aspartate Aminotransferase ↑ BL Gr 1 → PB Gr 4
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Gamma-Glutamyl Transferase ↑ BL Gr NA → PB Gr 3
denoms
  1. counts
    1. group Id
      OG000
      value
      52
    2. group Id
      OG001
      value
      54
    units
    Participants
description
Severity was graded according to the CTCAE version 4.03: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death. Increases (↑) or decreases (↓) in laboratory value grades (Gr) from baseline (BL) to worst postbaseline (→ PB) grade are presented. NA=not available.
groups
  1. description
    One week of treatment with HC3 followed by 3 weeks of no treatment. The standard intensive consolidation chemotherapy course HC3 includes dexamethasone (10 mg/m\^2/day IV on Days 1-6), vincrisitne (1.5 mg/m\^2/day IV on Days 1 and 6), daunorubicin (30 mg/m\^2 IV over 24 hours on Day 5), methotrexate (1 g/m\^2 IV over 36 hours on Day 1), ifosfamide (800 mg/m\^2 IV for 1 hour on Days 2-4), and pegylated \[PEG\]-asparaginase (1000 U/m\^2 IV for 2 hours or IM on Day 6) or, if allergic, erwinia-asparaginase (20,000 units/m\^2 IV or IM every 48 hours for a total of 6 doses).
    id
    OG000
    title
    HC3 Chemotherapy
  2. description
    One 4-week cycle of blinatumomab 15 μg/m\^2/day as a continuous intravenous infusion (CIVI).
    id
    OG001
    title
    Blinatumomab
param Type
NUMBER
population Description
Safety Analysis Set: who received protocol-specified therapy analyzed according to the treatment they received.
reporting Status
POSTED
time Frame
Up to Day 29 (± 2 days).
title
Number of Participants With Shifts From Baseline Grade 0 or 1 to Worst Postbaseline Grade 3 or 4 Clinical Chemistry and Hematology Values
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice