NCT02000427 · OUTCOME

Steady State Concentration of Blinatumomab

Blinatumomab in Adults With Relapsed/Refractory Philadelphia Positive B-precursor Acute Lymphoblastic Leukemia · Source last updated 2024-05-28

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: GEOMETRIC_MEAN
Unit: pg/mL
Interval / dispersion: Geometric Coefficient of Variation
Time frame: Cycle 1, day 8, 6 to 8 hours after the dose step to 28 μg/day, and Cycle 2, day 1, 6 to 8 hours after blinatumomab infusion

Analysis population: Participants with available serum concentration data

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 2 cycles. Participants who achieved a complete remission or complete remission with partial or incomplete hematologic recovery within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab. The initial dose was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 and for all subsequent 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

Group	Source count
Blinatumomab	28

Reported measurements

Cycle 1

Values in pg/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Blinatumomab	449	125.6	Not reported	Not reported	Not reported

Cycle 2 (n = 21)

Values in pg/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Blinatumomab	532	128.7	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
125.6
value
449
title
Cycle 1
categories
measurements
group Id
OG000
spread
128.7
value
532
title
Cycle 2 (n = 21)

denoms

counts
group Id
OG000
value
28
units
Participants

dispersion Type

Geometric Coefficient of Variation

groups

description
Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for 2 cycles. Participants who achieved a complete remission or complete remission with partial or incomplete hematologic recovery within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab. The initial dose was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 and for all subsequent cycles of treatment.
id
OG000
title
Blinatumomab

param Type

GEOMETRIC_MEAN

population Description

Participants with available serum concentration data

reporting Status

POSTED

time Frame

Cycle 1, day 8, 6 to 8 hours after the dose step to 28 μg/day, and Cycle 2, day 1, 6 to 8 hours after blinatumomab infusion

title

Steady State Concentration of Blinatumomab

type

SECONDARY

unit Of Measure

pg/mL

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

Preserved source evidence · Not medical advice