NCT03860844 · OUTCOME
B-ALL and T-ALL: Plasma Concentration Reached by Isatuximab Before Next Dose Administration (Ctrough)
Isatuximab in Combination With Chemotherapy in Pediatric Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia · Source last updated 2025-09-09
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- microgram/milliliter (mcg/mL)
- Interval / dispersion
- Standard Deviation
- Time frame
- Cycle 1 Day 8, Cycle 1 Day 15, Cycle 1 Day 22, Cycle 1 Day 29, Cycle 2 Day 43, Cycle 2 Day 57
What was measured
Plasma samples were collected at specified timepoints to determine the Ctrough of isatuximab.
Analysis population: The PK population consisted of all participants from the AT population with at least 1 PK parameter available (isatuximab concentration). Only those participants with data available at specified timepoints were analyzed.
Groups in this outcome
B-cell Acute Lymphoblastic Leukemia (B-ALL)
Participants with B-ALL received isatuximab 20 mg/kg IV infusion QW for 4 weeks during the induction period (i.e., on Days 1, 8, 15, and 22) and Q2W during the consolidation period (i.e., on Days 29, 43, and 57. Participants received recommended isatuximab premedication as per protocol. Starting on Day 8, combination chemotherapies were added. Participants without documented disease progression at EOT visit who had not started treatment with another anticancer therapy received follow-up visits every 2 months until initiation of another anticancer therapy, disease progression, death, or final analysis cut-off date, whichever occurred first. Participants with documented disease progression/initiation of new anticancer treatment were followed for survival every 4 months until death or final analysis cut-off date, whichever occurred first.
T-cell Acute Lymphoblastic Leukemia (T-ALL)
Participants with T-ALL received isatuximab 20 mg/kg IV infusion QW for 4 weeks during the induction period (i.e., on Days 1, 8, 15, and 22) and Q2W during the consolidation period (i.e., on Days 29, 43, and 57. Participants received recommended isatuximab premedication as per protocol. Starting on Day 8, combination chemotherapies were added. Participants without documented disease progression at EOT visit who had not started treatment with another anticancer therapy received follow-up visits every 2 months until initiation of another anticancer therapy, disease progression, death, or final analysis cut-off date, whichever occurred first. Participants with documented disease progression/initiation of new anticancer treatment were followed for survival every 4 months until death or final analysis cut-off date, whichever occurred first.
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 |
|---|
| B-cell Acute Lymphoblastic Leukemia (B-ALL) | 27 |
|---|
| T-cell Acute Lymphoblastic Leukemia (T-ALL) | 13 |
|---|
Reported measurements
Cycle 1: Day 8
Analysis denominator · Participants
| Group | Source count |
|---|
| B-cell Acute Lymphoblastic Leukemia (B-ALL) | 25 |
|---|
| T-cell Acute Lymphoblastic Leukemia (T-ALL) | 11 |
|---|
Values in microgram/milliliter (mcg/mL) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| B-cell Acute Lymphoblastic Leukemia (B-ALL) | 114 | 45.7 | Not reported | Not reported | Not reported |
|---|
| T-cell Acute Lymphoblastic Leukemia (T-ALL) | 127 | 49.9 | Not reported | Not reported | Not reported |
|---|
Cycle 1: Day 15
Analysis denominator · Participants
| Group | Source count |
|---|
| B-cell Acute Lymphoblastic Leukemia (B-ALL) | 23 |
|---|
| T-cell Acute Lymphoblastic Leukemia (T-ALL) | 11 |
|---|
Values in microgram/milliliter (mcg/mL) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| B-cell Acute Lymphoblastic Leukemia (B-ALL) | 272 | 118 | Not reported | Not reported | Not reported |
|---|
| T-cell Acute Lymphoblastic Leukemia (T-ALL) | 263 | 103 | Not reported | Not reported | Not reported |
|---|
Cycle 1: Day 22
Analysis denominator · Participants
| Group | Source count |
|---|
| B-cell Acute Lymphoblastic Leukemia (B-ALL) | 15 |
|---|
| T-cell Acute Lymphoblastic Leukemia (T-ALL) | 8 |
|---|
Values in microgram/milliliter (mcg/mL) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| B-cell Acute Lymphoblastic Leukemia (B-ALL) | 388 | 163 | Not reported | Not reported | Not reported |
|---|
| T-cell Acute Lymphoblastic Leukemia (T-ALL) | 323 | 206 | Not reported | Not reported | Not reported |
|---|
Cycle 1: Day 29
Analysis denominator · Participants
| Group | Source count |
|---|
| B-cell Acute Lymphoblastic Leukemia (B-ALL) | 18 |
|---|
| T-cell Acute Lymphoblastic Leukemia (T-ALL) | 9 |
|---|
Values in microgram/milliliter (mcg/mL) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| B-cell Acute Lymphoblastic Leukemia (B-ALL) | 475 | 174 | Not reported | Not reported | Not reported |
|---|
| T-cell Acute Lymphoblastic Leukemia (T-ALL) | 426 | 209 | Not reported | Not reported | Not reported |
|---|
Cycle 2: Day 43
Analysis denominator · Participants
| Group | Source count |
|---|
| B-cell Acute Lymphoblastic Leukemia (B-ALL) | 5 |
|---|
| T-cell Acute Lymphoblastic Leukemia (T-ALL) | 1 |
|---|
Values in microgram/milliliter (mcg/mL) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| B-cell Acute Lymphoblastic Leukemia (B-ALL) | 504 | 296 | Not reported | Not reported | Not reported |
|---|
| T-cell Acute Lymphoblastic Leukemia (T-ALL) | 357 | NA | Not reported | Not reported | Standard deviation (SD) could not be calculated for a single participant. |
|---|
Cycle 2: Day 57
Analysis denominator · Participants
| Group | Source count |
|---|
| B-cell Acute Lymphoblastic Leukemia (B-ALL) | 8 |
|---|
| T-cell Acute Lymphoblastic Leukemia (T-ALL) | 2 |
|---|
Values in microgram/milliliter (mcg/mL) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| B-cell Acute Lymphoblastic Leukemia (B-ALL) | 531 | 224 | Not reported | Not reported | Not reported |
|---|
| T-cell Acute Lymphoblastic Leukemia (T-ALL) | 478 | 261 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 45.7
- value
- 114
- group Id
- OG001
- spread
- 49.9
- value
- 127
- denoms
- counts
- group Id
- OG000
- value
- 25
- group Id
- OG001
- value
- 11
- units
- Participants
- title
- Cycle 1: Day 8
- categories
- measurements
- group Id
- OG000
- spread
- 118
- value
- 272
- group Id
- OG001
- spread
- 103
- value
- 263
- denoms
- counts
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 11
- units
- Participants
- title
- Cycle 1: Day 15
- categories
- measurements
- group Id
- OG000
- spread
- 163
- value
- 388
- group Id
- OG001
- spread
- 206
- value
- 323
- denoms
- counts
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 8
- units
- Participants
- title
- Cycle 1: Day 22
- categories
- measurements
- group Id
- OG000
- spread
- 174
- value
- 475
- group Id
- OG001
- spread
- 209
- value
- 426
- denoms
- counts
- group Id
- OG000
- value
- 18
- group Id
- OG001
- value
- 9
- units
- Participants
- title
- Cycle 1: Day 29
- categories
- measurements
- group Id
- OG000
- spread
- 296
- value
- 504
- comment
- Standard deviation (SD) could not be calculated for a single participant.
- group Id
- OG001
- spread
- NA
- value
- 357
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 1
- units
- Participants
- title
- Cycle 2: Day 43
- categories
- measurements
- group Id
- OG000
- spread
- 224
- value
- 531
- group Id
- OG001
- spread
- 261
- value
- 478
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 2
- units
- Participants
- title
- Cycle 2: Day 57
- denoms
- counts
- group Id
- OG000
- value
- 27
- group Id
- OG001
- value
- 13
- units
- Participants
- description
- Plasma samples were collected at specified timepoints to determine the Ctrough of isatuximab.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants with B-ALL received isatuximab 20 mg/kg IV infusion QW for 4 weeks during the induction period (i.e., on Days 1, 8, 15, and 22) and Q2W during the consolidation period (i.e., on Days 29, 43, and 57. Participants received recommended isatuximab premedication as per protocol. Starting on Day 8, combination chemotherapies were added. Participants without documented disease progression at EOT visit who had not started treatment with another anticancer therapy received follow-up visits every 2 months until initiation of another anticancer therapy, disease progression, death, or final analysis cut-off date, whichever occurred first. Participants with documented disease progression/initiation of new anticancer treatment were followed for survival every 4 months until death or final analysis cut-off date, whichever occurred first.
- id
- OG000
- title
- B-cell Acute Lymphoblastic Leukemia (B-ALL)
- description
- Participants with T-ALL received isatuximab 20 mg/kg IV infusion QW for 4 weeks during the induction period (i.e., on Days 1, 8, 15, and 22) and Q2W during the consolidation period (i.e., on Days 29, 43, and 57. Participants received recommended isatuximab premedication as per protocol. Starting on Day 8, combination chemotherapies were added. Participants without documented disease progression at EOT visit who had not started treatment with another anticancer therapy received follow-up visits every 2 months until initiation of another anticancer therapy, disease progression, death, or final analysis cut-off date, whichever occurred first. Participants with documented disease progression/initiation of new anticancer treatment were followed for survival every 4 months until death or final analysis cut-off date, whichever occurred first.
- id
- OG001
- title
- T-cell Acute Lymphoblastic Leukemia (T-ALL)
- param Type
- MEAN
- population Description
- The PK population consisted of all participants from the AT population with at least 1 PK parameter available (isatuximab concentration). Only those participants with data available at specified timepoints were analyzed.
- reporting Status
- POSTED
- time Frame
- Cycle 1 Day 8, Cycle 1 Day 15, Cycle 1 Day 22, Cycle 1 Day 29, Cycle 2 Day 43, Cycle 2 Day 57
- title
- B-ALL and T-ALL: Plasma Concentration Reached by Isatuximab Before Next Dose Administration (Ctrough)
- type
- SECONDARY
- unit Of Measure
- microgram/milliliter (mcg/mL)
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Preserved source evidence · Not medical advice
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