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NCT01466179 · OUTCOME

Serum Cytokine Peak Levels

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
MEAN
Unit
pg/mL
Interval / dispersion
Standard Deviation
Time frame
Serum samples were collected on Days 1 and 8 at 2 hours and 6 hours after treatment start, and on Day 2 (24 hours) and Day 3 (48 hours) of each treatment cycle and on Days 9 and 10 after dose step.

What was measured

The activation of immune effector cells was monitored by the measurement of peripheral blood cytokine levels including interleukin (IL)-2, IL-4, IL-6, IL-10, tumor necrosis factor (TNF)-α and interferon gamma (IFN)-γ using enzyme-linked immunosorbent assays or cytometric bead assays. The limit of detection of the assay (LOD) was 20 pg/mL and the limit of quantification (LOQ) was 125 pg/mL. Data below LOD were set to 10 pg/mL while data \< LOQ and \> LOD were reported as measured. Serum IL-4 levels were below detection limit (\< 20 pg/mL) at all time points in all participants studied.

Analysis population: Pharmacodynamic Data Set (PDS): All patients who received any infusion of blinatumomab and had at least one pharmacodynamic sample collected. N indicates the number of participants with available data at each time point.

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

IFN-Ɣ: Cycle 1 Week 1 (N=184)
Values in pg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Blinatumomab93.1409Not reportedNot reportedNot reported
IFN-Ɣ: Cycle 1 Week 2 (N=175)
Values in pg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Blinatumomab27.483.1Not reportedNot reportedNot reported
IFN-Ɣ: Cycle 2 Week 1 (N=95)
Values in pg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Blinatumomab22.845.8Not reportedNot reportedNot reported
IFN-Ɣ: Cycle 3 Week 1 (N=41)
Values in pg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Blinatumomab21.627.6Not reportedNot reportedNot reported
IL-10: Cycle 1 Week 1 (N=184)
Values in pg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Blinatumomab589822Not reportedNot reportedNot reported
IL-10: Cycle 1 Week 2 (N=175)
Values in pg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Blinatumomab95.7136Not reportedNot reportedNot reported
IL-10: Cycle 2 Week 1 (N=95)
Values in pg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Blinatumomab397633Not reportedNot reportedNot reported
IL-10: Cycle 3 Week 1 (N=41)
Values in pg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Blinatumomab428941Not reportedNot reportedNot reported
IL-2: Cycle 1 Week 1 (N=184)
Values in pg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Blinatumomab24.744.6Not reportedNot reportedNot reported
IL-2: Cycle 1 Week 2 (N=175)
Values in pg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Blinatumomab10.85.21Not reportedNot reportedNot reported
IL-2: Cycle 2 Week 1 (N=95)
Values in pg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Blinatumomab115.17Not reportedNot reportedNot reported
IL-2: Cycle 3 Week 1 (N=41)
Values in pg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Blinatumomab10.32.03Not reportedNot reportedNot reported
IL-6: Cycle 1 Week 1 (N=184)
Values in pg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Blinatumomab8262390Not reportedNot reportedNot reported
IL-6: Cycle 1 Week 2 (N=175)
Values in pg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Blinatumomab234681Not reportedNot reportedNot reported
IL-6: Cycle 2 Week 1 (N=95)
Values in pg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Blinatumomab315952Not reportedNot reportedNot reported
IL-6: Cycle 3 Week 1 (N=41)
Values in pg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Blinatumomab69.2114Not reportedNot reportedNot reported
TNF-α: Cycle 1 Week 1 (N=184)
Values in pg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Blinatumomab30125Not reportedNot reportedNot reported
TNF-α: Cycle 1 Week 2 (N=175)
Values in pg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Blinatumomab10.33.33Not reportedNot reportedNot reported
TNF-α: Cycle 2 Week 1 (N=95)
Values in pg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Blinatumomab12.115Not reportedNot reportedNot reported
TNF-α: Cycle 3 Week 1 (N=41)
Values in pg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Blinatumomab127.79Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        409
        value
        93.1
    title
    IFN-Ɣ: Cycle 1 Week 1 (N=184)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        83.1
        value
        27.4
    title
    IFN-Ɣ: Cycle 1 Week 2 (N=175)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        45.8
        value
        22.8
    title
    IFN-Ɣ: Cycle 2 Week 1 (N=95)
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        27.6
        value
        21.6
    title
    IFN-Ɣ: Cycle 3 Week 1 (N=41)
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        822
        value
        589
    title
    IL-10: Cycle 1 Week 1 (N=184)
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        136
        value
        95.7
    title
    IL-10: Cycle 1 Week 2 (N=175)
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        633
        value
        397
    title
    IL-10: Cycle 2 Week 1 (N=95)
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        941
        value
        428
    title
    IL-10: Cycle 3 Week 1 (N=41)
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        44.6
        value
        24.7
    title
    IL-2: Cycle 1 Week 1 (N=184)
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.21
        value
        10.8
    title
    IL-2: Cycle 1 Week 2 (N=175)
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.17
        value
        11
    title
    IL-2: Cycle 2 Week 1 (N=95)
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.03
        value
        10.3
    title
    IL-2: Cycle 3 Week 1 (N=41)
denoms
  1. counts
    1. group Id
      OG000
      value
      189
    units
    Participants
description
The activation of immune effector cells was monitored by the measurement of peripheral blood cytokine levels including interleukin (IL)-2, IL-4, IL-6, IL-10, tumor necrosis factor (TNF)-α and interferon gamma (IFN)-γ using enzyme-linked immunosorbent assays or cytometric bead assays. The limit of detection of the assay (LOD) was 20 pg/mL and the limit of quantification (LOQ) was 125 pg/mL. Data below LOD were set to 10 pg/mL while data \< LOQ and \> LOD were reported as measured. Serum IL-4 levels were below detection limit (\< 20 pg/mL) at all time points in all participants studied.
dispersion Type
Standard Deviation
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
MEAN
population Description
Pharmacodynamic Data Set (PDS): All patients who received any infusion of blinatumomab and had at least one pharmacodynamic sample collected. N indicates the number of participants with available data at each time point.
reporting Status
POSTED
time Frame
Serum samples were collected on Days 1 and 8 at 2 hours and 6 hours after treatment start, and on Day 2 (24 hours) and Day 3 (48 hours) of each treatment cycle and on Days 9 and 10 after dose step.
title
Serum Cytokine Peak Levels
type
SECONDARY
unit Of Measure
pg/mL

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Preserved source evidence · Not medical advice