NCT01471782 · OUTCOME
Serum Cytokine Peak Levels
Clinical Study With Blinatumomab in Pediatric and Adolescent Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia · Source last updated 2017-02-08
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
- Cycle 1 and 2 day 1 (prior to infusion, 2 and 6 hours after infusion start), day 2 and day 3.
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-alpha (TNF-α) and interferon gamma (IFN-ɣ) using cytometric bead assays. The limit of detection of the assay (LOD) was 20 pg/mL and the lower limit of quantification (LLOQ) was 125 pg/mL. Data below LOD were set to 10 pg/mL while data \< LOQ and \> LOD were reported as measured.
Analysis population: Phase 1 full analysis set participants with available data
Groups in this outcome
Phase 1: Blinatumomab 5 µg/m²/Day
Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day..
Phase 1: Blinatumomab 15 µg/m²/Day
Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day.
Phase 1: Blinatumomab 30 µg/m²/Day
Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day.
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 |
|---|
| Phase 1: Blinatumomab 5 µg/m²/Day | 31 |
|---|
| Phase 1: Blinatumomab 15 µg/m²/Day | 14 |
|---|
| Phase 1: Blinatumomab 30 µg/m²/Day | 5 |
|---|
Reported measurements
IL-6: Cycle 1 Week 1 (N=31, 13, 5)
Values in pg/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1: Blinatumomab 5 µg/m²/Day | 4970 | 17000 | Not reported | Not reported | Not reported |
|---|
| Phase 1: Blinatumomab 15 µg/m²/Day | 1780 | 2620 | Not reported | Not reported | Not reported |
|---|
| Phase 1: Blinatumomab 30 µg/m²/Day | 23400 | 24100 | Not reported | Not reported | Not reported |
|---|
IL-6: Cycle 2 Week 1 (N=4, 14, 5)
Values in pg/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1: Blinatumomab 5 µg/m²/Day | 526 | 844 | Not reported | Not reported | Not reported |
|---|
| Phase 1: Blinatumomab 15 µg/m²/Day | 892 | 2370 | Not reported | Not reported | Not reported |
|---|
| Phase 1: Blinatumomab 30 µg/m²/Day | 40.4 | 68.0 | Not reported | Not reported | Not reported |
|---|
IL-10: Cycle 1 Week 1 (N=31, 13, 5)
Values in pg/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1: Blinatumomab 5 µg/m²/Day | 562 | 710 | Not reported | Not reported | Not reported |
|---|
| Phase 1: Blinatumomab 15 µg/m²/Day | 1400 | 2030 | Not reported | Not reported | Not reported |
|---|
| Phase 1: Blinatumomab 30 µg/m²/Day | 3170 | 1720 | Not reported | Not reported | Not reported |
|---|
IL-10: Cycle 2 Week 1 (N=4, 14, 5)
Values in pg/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1: Blinatumomab 5 µg/m²/Day | 519 | 497 | Not reported | Not reported | Not reported |
|---|
| Phase 1: Blinatumomab 15 µg/m²/Day | 432 | 692 | Not reported | Not reported | Not reported |
|---|
| Phase 1: Blinatumomab 30 µg/m²/Day | 277 | 308 | Not reported | Not reported | Not reported |
|---|
IFN-ɣ: Cycle 1 Week 1 (N=31, 13, 5)
Values in pg/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1: Blinatumomab 5 µg/m²/Day | 207 | 516 | Not reported | Not reported | Not reported |
|---|
| Phase 1: Blinatumomab 15 µg/m²/Day | 539 | 1240 | Not reported | Not reported | Not reported |
|---|
| Phase 1: Blinatumomab 30 µg/m²/Day | 2260 | 1540 | Not reported | Not reported | Not reported |
|---|
IFN-ɣ: Cycle 2 Week 1 (N=4, 14, 5)
Values in pg/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1: Blinatumomab 5 µg/m²/Day | 51.8 | 65.6 | Not reported | Not reported | Not reported |
|---|
| Phase 1: Blinatumomab 15 µg/m²/Day | 47.6 | 51.5 | Not reported | Not reported | Not reported |
|---|
| Phase 1: Blinatumomab 30 µg/m²/Day | 22.8 | 28.6 | Not reported | Not reported | Not reported |
|---|
IL-2: Cycle 1 Week 1 (N=31, 13, 5)
Values in pg/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1: Blinatumomab 5 µg/m²/Day | 22.7 | 23 | Not reported | Not reported | Not reported |
|---|
| Phase 1: Blinatumomab 15 µg/m²/Day | 93.9 | 150 | Not reported | Not reported | Not reported |
|---|
| Phase 1: Blinatumomab 30 µg/m²/Day | 900 | 1390 | Not reported | Not reported | Not reported |
|---|
IL-2: Cycle 2 Week 1 (N=4, 14, 5)
Values in pg/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1: Blinatumomab 5 µg/m²/Day | 10.0 | 0.00 | Not reported | Not reported | Not reported |
|---|
| Phase 1: Blinatumomab 15 µg/m²/Day | 14.3 | 8.84 | Not reported | Not reported | Not reported |
|---|
| Phase 1: Blinatumomab 30 µg/m²/Day | 10.0 | 0.00 | Not reported | Not reported | Not reported |
|---|
TNF-α: Cycle 1 Week 1 (N=31, 13, 5)
Values in pg/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1: Blinatumomab 5 µg/m²/Day | 87.3 | 241 | Not reported | Not reported | Not reported |
|---|
| Phase 1: Blinatumomab 15 µg/m²/Day | 60.2 | 127 | Not reported | Not reported | Not reported |
|---|
| Phase 1: Blinatumomab 30 µg/m²/Day | 285 | 306 | Not reported | Not reported | Not reported |
|---|
TNF-α: Cycle 2 Week 1 (N=4, 14, 5)
Values in pg/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1: Blinatumomab 5 µg/m²/Day | 10.0 | 0.00 | Not reported | Not reported | Not reported |
|---|
| Phase 1: Blinatumomab 15 µg/m²/Day | 10.0 | 0.00 | Not reported | Not reported | Not reported |
|---|
| Phase 1: Blinatumomab 30 µg/m²/Day | 10.0 | 0.00 | Not reported | Not reported | Not reported |
|---|
IL-4: Cycle 1 Week 1 (N=0, 0, 0)
Values in pg/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1: Blinatumomab 5 µg/m²/Day | NA | NA | Not reported | Not reported | Serum IL-4 levels were below detection limit (\< 20 pg/mL) in all participants studied. |
|---|
| Phase 1: Blinatumomab 15 µg/m²/Day | NA | NA | Not reported | Not reported | Serum IL-4 levels were below detection limit (\< 20 pg/mL) in all participants studied. |
|---|
| Phase 1: Blinatumomab 30 µg/m²/Day | NA | NA | Not reported | Not reported | Serum IL-4 levels were below detection limit (\< 20 pg/mL) in all participants studied. |
|---|
IL-4: Cycle 2 Week 1 (N=0, 0, 0)
Values in pg/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 1: Blinatumomab 5 µg/m²/Day | NA | NA | Not reported | Not reported | Serum IL-4 levels were below detection limit (\< 20 pg/mL) in all participants studied. |
|---|
| Phase 1: Blinatumomab 15 µg/m²/Day | NA | NA | Not reported | Not reported | Serum IL-4 levels were below detection limit (\< 20 pg/mL) in all participants studied. |
|---|
| Phase 1: Blinatumomab 30 µg/m²/Day | NA | NA | Not reported | Not reported | Serum IL-4 levels were below detection limit (\< 20 pg/mL) in all participants studied. |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 17000
- value
- 4970
- group Id
- OG001
- spread
- 2620
- value
- 1780
- group Id
- OG002
- spread
- 24100
- value
- 23400
- title
- IL-6: Cycle 1 Week 1 (N=31, 13, 5)
- categories
- measurements
- group Id
- OG000
- spread
- 844
- value
- 526
- group Id
- OG001
- spread
- 2370
- value
- 892
- group Id
- OG002
- spread
- 68.0
- value
- 40.4
- title
- IL-6: Cycle 2 Week 1 (N=4, 14, 5)
- categories
- measurements
- group Id
- OG000
- spread
- 710
- value
- 562
- group Id
- OG001
- spread
- 2030
- value
- 1400
- group Id
- OG002
- spread
- 1720
- value
- 3170
- title
- IL-10: Cycle 1 Week 1 (N=31, 13, 5)
- categories
- measurements
- group Id
- OG000
- spread
- 497
- value
- 519
- group Id
- OG001
- spread
- 692
- value
- 432
- group Id
- OG002
- spread
- 308
- value
- 277
- title
- IL-10: Cycle 2 Week 1 (N=4, 14, 5)
- categories
- measurements
- group Id
- OG000
- spread
- 516
- value
- 207
- group Id
- OG001
- spread
- 1240
- value
- 539
- group Id
- OG002
- spread
- 1540
- value
- 2260
- title
- IFN-ɣ: Cycle 1 Week 1 (N=31, 13, 5)
- categories
- measurements
- group Id
- OG000
- spread
- 65.6
- value
- 51.8
- group Id
- OG001
- spread
- 51.5
- value
- 47.6
- group Id
- OG002
- spread
- 28.6
- value
- 22.8
- title
- IFN-ɣ: Cycle 2 Week 1 (N=4, 14, 5)
- categories
- measurements
- group Id
- OG000
- spread
- 23
- value
- 22.7
- group Id
- OG001
- spread
- 150
- value
- 93.9
- group Id
- OG002
- spread
- 1390
- value
- 900
- title
- IL-2: Cycle 1 Week 1 (N=31, 13, 5)
- categories
- measurements
- group Id
- OG000
- spread
- 0.00
- value
- 10.0
- group Id
- OG001
- spread
- 8.84
- value
- 14.3
- group Id
- OG002
- spread
- 0.00
- value
- 10.0
- title
- IL-2: Cycle 2 Week 1 (N=4, 14, 5)
- categories
- measurements
- group Id
- OG000
- spread
- 241
- value
- 87.3
- group Id
- OG001
- spread
- 127
- value
- 60.2
- group Id
- OG002
- spread
- 306
- value
- 285
- title
- TNF-α: Cycle 1 Week 1 (N=31, 13, 5)
- categories
- measurements
- group Id
- OG000
- spread
- 0.00
- value
- 10.0
- group Id
- OG001
- spread
- 0.00
- value
- 10.0
- group Id
- OG002
- spread
- 0.00
- value
- 10.0
- title
- TNF-α: Cycle 2 Week 1 (N=4, 14, 5)
- categories
- measurements
- comment
- Serum IL-4 levels were below detection limit (\< 20 pg/mL) in all participants studied.
- group Id
- OG000
- spread
- NA
- value
- NA
- comment
- Serum IL-4 levels were below detection limit (\< 20 pg/mL) in all participants studied.
- group Id
- OG001
- spread
- NA
- value
- NA
- comment
- Serum IL-4 levels were below detection limit (\< 20 pg/mL) in all participants studied.
- group Id
- OG002
- spread
- NA
- value
- NA
- title
- IL-4: Cycle 1 Week 1 (N=0, 0, 0)
- categories
- measurements
- comment
- Serum IL-4 levels were below detection limit (\< 20 pg/mL) in all participants studied.
- group Id
- OG000
- spread
- NA
- value
- NA
- comment
- Serum IL-4 levels were below detection limit (\< 20 pg/mL) in all participants studied.
- group Id
- OG001
- spread
- NA
- value
- NA
- comment
- Serum IL-4 levels were below detection limit (\< 20 pg/mL) in all participants studied.
- group Id
- OG002
- spread
- NA
- value
- NA
- title
- IL-4: Cycle 2 Week 1 (N=0, 0, 0)
- denoms
- counts
- group Id
- OG000
- value
- 31
- group Id
- OG001
- value
- 14
- group Id
- OG002
- value
- 5
- 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-alpha (TNF-α) and interferon gamma (IFN-ɣ) using cytometric bead assays. The limit of detection of the assay (LOD) was 20 pg/mL and the lower limit of quantification (LLOQ) was 125 pg/mL. Data below LOD were set to 10 pg/mL while data \< LOQ and \> LOD were reported as measured.
- dispersion Type
- Standard Deviation
- groups
- description
- Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day..
- id
- OG000
- title
- Phase 1: Blinatumomab 5 µg/m²/Day
- description
- Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day.
- id
- OG001
- title
- Phase 1: Blinatumomab 15 µg/m²/Day
- description
- Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day.
- id
- OG002
- title
- Phase 1: Blinatumomab 30 µg/m²/Day
- param Type
- MEAN
- population Description
- Phase 1 full analysis set participants with available data
- reporting Status
- POSTED
- time Frame
- Cycle 1 and 2 day 1 (prior to infusion, 2 and 6 hours after infusion start), day 2 and day 3.
- title
- Serum Cytokine Peak Levels
- type
- SECONDARY
- unit Of Measure
- pg/mL
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