Trial Outcomes & Findings for A Study Comparing the Blood Levels of Both Pegaspargase (S95014) Formulations (Liquid vs Lyophilized) in the Treatment of Paediatric Patients With Acute Lymphoblastic Leukemia (ALL) (NCT NCT04954326)
NCT ID: NCT04954326
Last Updated: 2023-07-12
Results Overview
Area Under the Plasma Asparaginase activity - Time curve from Time zero to infinity (AUCinf)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
89 participants
Primary outcome timeframe
Predose up to 600 hours
Results posted on
2023-07-12
Participant Flow
There was a sceening period (from Day-14 to Day-1) to check the eligibility of the patient in the study
Participant milestones
| Measure |
S95014 Lyophilizate
Lyophilized S95014 reconstituted will provide 5 mL of extractable volume with the concentration of 750 U/mL. The vial of lyophilized powder (3.750 U/vial) is reconstituted with 5.2 mL of Sterile Water for Injection to obtain a 750 U/mL solution for single use.
Lyophilized S95014: Lyophilized S95014 will be intravenously administered over 1 hour at the dose of 2500 U/m2 at Day 3 of the induction phase.
Patients will receive other backbone chemotherapy agents as per ALL-MB 2015 protocol.
|
S95014 Liquid
Liquid S95014 is provided as 3.750 U per 5 mL solution in a single use vial to obtain a 750 U/mL solution for single use.
Liquid S95014: Liquid S95014 will be intravenously administered over 1 hour at the dose of 2500 U/m2 at Day 3 of the induction phase.
Patients will receive other backbone chemotherapy agents as per ALL-MB 2015 protocol.
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
45
|
|
Overall Study
COMPLETED
|
44
|
41
|
|
Overall Study
NOT COMPLETED
|
0
|
4
|
Reasons for withdrawal
| Measure |
S95014 Lyophilizate
Lyophilized S95014 reconstituted will provide 5 mL of extractable volume with the concentration of 750 U/mL. The vial of lyophilized powder (3.750 U/vial) is reconstituted with 5.2 mL of Sterile Water for Injection to obtain a 750 U/mL solution for single use.
Lyophilized S95014: Lyophilized S95014 will be intravenously administered over 1 hour at the dose of 2500 U/m2 at Day 3 of the induction phase.
Patients will receive other backbone chemotherapy agents as per ALL-MB 2015 protocol.
|
S95014 Liquid
Liquid S95014 is provided as 3.750 U per 5 mL solution in a single use vial to obtain a 750 U/mL solution for single use.
Liquid S95014: Liquid S95014 will be intravenously administered over 1 hour at the dose of 2500 U/m2 at Day 3 of the induction phase.
Patients will receive other backbone chemotherapy agents as per ALL-MB 2015 protocol.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Death
|
0
|
2
|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
A Study Comparing the Blood Levels of Both Pegaspargase (S95014) Formulations (Liquid vs Lyophilized) in the Treatment of Paediatric Patients With Acute Lymphoblastic Leukemia (ALL)
Baseline characteristics by cohort
| Measure |
S95014 Lyophilizate
n=43 Participants
Lyophilized S95014 reconstituted will provide 5 mL of extractable volume with the concentration of 750 U/mL. The vial of lyophilized powder (3.750 U/vial) is reconstituted with 5.2 mL of Sterile Water for Injection to obtain a 750 U/mL solution for single use.
Lyophilized S95014: Lyophilized S95014 will be intravenously administered over 1 hour at the dose of 2500 U/m2 at Day 3 of the induction phase.
Patients will receive other backbone chemotherapy agents as per ALL-MB 2015 protocol.
|
S95014 Liquid
n=45 Participants
Liquid S95014 is provided as 3.750 U per 5 mL solution in a single use vial to obtain a 750 U/mL solution for single use.
Liquid S95014: Liquid S95014 will be intravenously administered over 1 hour at the dose of 2500 U/m2 at Day 3 of the induction phase.
Patients will receive other backbone chemotherapy agents as per ALL-MB 2015 protocol.
|
Total
n=88 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
43 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
6.9 years
STANDARD_DEVIATION 4.28 • n=5 Participants
|
5.4 years
STANDARD_DEVIATION 3.52 • n=7 Participants
|
6.1 years
STANDARD_DEVIATION 3.96 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Russia
|
43 participants
n=5 Participants
|
45 participants
n=7 Participants
|
88 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Predose up to 600 hoursPopulation: The Pharmacokinetic (PK) Analysis Set included the patients who have received at least one dose of IMP and are evaluable for PK analysis : the patients who had enough samples collected to provide interpretable PK results with no deviations that might have affected the PK interpretation (e.g. infusion interrupted for any reason, deviation in the theoretical administered dose \> 10%, at least one missing PK sample during the 48 first hours, ≥ 2 missing PK samples after the 48-hour time point).
Area Under the Plasma Asparaginase activity - Time curve from Time zero to infinity (AUCinf)
Outcome measures
| Measure |
S95014 Lyophilizate
n=41 Participants
Lyophilized S95014 reconstituted will provide 5 mL of extractable volume with the concentration of 750 U/mL. The vial of lyophilized powder (3.750 U/vial) is reconstituted with 5.2 mL of Sterile Water for Injection to obtain a 750 U/mL solution for single use.
Lyophilized S95014: Lyophilized S95014 will be intravenously administered over 1 hour at the dose of 2500 U/m2 at Day 3 of the induction phase.
Patients will receive other backbone chemotherapy agents as per ALL-MB 2015 protocol.
|
S95014 Liquid
n=39 Participants
Liquid S95014 is provided as 3.750 U per 5 mL solution in a single use vial to obtain a 750 U/mL solution for single use.
Liquid S95014: Liquid S95014 will be intravenously administered over 1 hour at the dose of 2500 U/m2 at Day 3 of the induction phase.
Patients will receive other backbone chemotherapy agents as per ALL-MB 2015 protocol.
|
|---|---|---|
|
Pharmacokinetics Measurement
|
362028.656 mU*day/mL
Geometric Coefficient of Variation 33.55
|
352248.907 mU*day/mL
Geometric Coefficient of Variation 31.08
|
PRIMARY outcome
Timeframe: Predose up to 600 hoursPopulation: The Pharmacokinetic (PK) Analysis Set included the patients who have received at least one dose of IMP and are evaluable for PK analysis : the patients who had enough samples collected to provide interpretable PK results with no deviations that might have affected the PK interpretation (e.g. infusion interrupted for any reason, deviation in the theoretical administered dose \> 10%, at least one missing PK sample during the 48 first hours, ≥ 2 missing PK samples after the 48-hour time point).
Maximum observed plasma asparaginase activity (Cmax)
Outcome measures
| Measure |
S95014 Lyophilizate
n=41 Participants
Lyophilized S95014 reconstituted will provide 5 mL of extractable volume with the concentration of 750 U/mL. The vial of lyophilized powder (3.750 U/vial) is reconstituted with 5.2 mL of Sterile Water for Injection to obtain a 750 U/mL solution for single use.
Lyophilized S95014: Lyophilized S95014 will be intravenously administered over 1 hour at the dose of 2500 U/m2 at Day 3 of the induction phase.
Patients will receive other backbone chemotherapy agents as per ALL-MB 2015 protocol.
|
S95014 Liquid
n=40 Participants
Liquid S95014 is provided as 3.750 U per 5 mL solution in a single use vial to obtain a 750 U/mL solution for single use.
Liquid S95014: Liquid S95014 will be intravenously administered over 1 hour at the dose of 2500 U/m2 at Day 3 of the induction phase.
Patients will receive other backbone chemotherapy agents as per ALL-MB 2015 protocol.
|
|---|---|---|
|
Pharmacokinetics Measurement
|
1563.115 mU/mL
Geometric Coefficient of Variation 23.11
|
1672.136 mU/mL
Geometric Coefficient of Variation 41.91
|
SECONDARY outcome
Timeframe: 14 days post-dosePopulation: The PKAS included the patients who have received at least one dose of IMP and are evaluable for PK analysis : the patients who had enough samples collected to provide interpretable PK results with no deviations that might have affected the PK interpretation . Cday-14 could not be calculated in one patient (in S95014 liquid group) who had only 3 positive values exceeding the Lower Limit of Quantification
Observed Plasma Asparaginase Activity 14 days post-dose (Cday 14) of S95014
Outcome measures
| Measure |
S95014 Lyophilizate
n=41 Participants
Lyophilized S95014 reconstituted will provide 5 mL of extractable volume with the concentration of 750 U/mL. The vial of lyophilized powder (3.750 U/vial) is reconstituted with 5.2 mL of Sterile Water for Injection to obtain a 750 U/mL solution for single use.
Lyophilized S95014: Lyophilized S95014 will be intravenously administered over 1 hour at the dose of 2500 U/m2 at Day 3 of the induction phase.
Patients will receive other backbone chemotherapy agents as per ALL-MB 2015 protocol.
|
S95014 Liquid
n=39 Participants
Liquid S95014 is provided as 3.750 U per 5 mL solution in a single use vial to obtain a 750 U/mL solution for single use.
Liquid S95014: Liquid S95014 will be intravenously administered over 1 hour at the dose of 2500 U/m2 at Day 3 of the induction phase.
Patients will receive other backbone chemotherapy agents as per ALL-MB 2015 protocol.
|
|---|---|---|
|
Pharmacokinetics Measurements
|
496.599 mU/mL
Geometric Coefficient of Variation 37.96
|
408.655 mU/mL
Geometric Coefficient of Variation 80.35
|
SECONDARY outcome
Timeframe: Day 7, 14, 18 and 25 post-dose of either liquid or lyophilized S95014Population: The analysis on the Plasma Asparaginase Actvity was performed on the Safety Set analysis, defined as the set of all patients who had received at least one dose of S95014 in the study.
Plasma Asparaginase Activity (PAA) of ≥ 0.1 U/mL after the administration of either liquid or lyophilized S95014.
Outcome measures
| Measure |
S95014 Lyophilizate
n=43 Participants
Lyophilized S95014 reconstituted will provide 5 mL of extractable volume with the concentration of 750 U/mL. The vial of lyophilized powder (3.750 U/vial) is reconstituted with 5.2 mL of Sterile Water for Injection to obtain a 750 U/mL solution for single use.
Lyophilized S95014: Lyophilized S95014 will be intravenously administered over 1 hour at the dose of 2500 U/m2 at Day 3 of the induction phase.
Patients will receive other backbone chemotherapy agents as per ALL-MB 2015 protocol.
|
S95014 Liquid
n=45 Participants
Liquid S95014 is provided as 3.750 U per 5 mL solution in a single use vial to obtain a 750 U/mL solution for single use.
Liquid S95014: Liquid S95014 will be intravenously administered over 1 hour at the dose of 2500 U/m2 at Day 3 of the induction phase.
Patients will receive other backbone chemotherapy agents as per ALL-MB 2015 protocol.
|
|---|---|---|
|
Activity Measurement
Number of patients who achieved Day 10 Plasma Asparaginase Activity (PAA) ≥ 0.1 U/mL
|
43 Participants
|
43 Participants
|
|
Activity Measurement
Number of patients who achieved Day 17 Plasma Asparaginase Activity (PAA) ≥ 0.1 U/mL
|
43 Participants
|
41 Participants
|
|
Activity Measurement
Number of patients who achieved Day 21 Plasma Asparaginase Activity (PAA) ≥ 0.1 U/mL
|
41 Participants
|
39 Participants
|
|
Activity Measurement
Number of patients who achieved Day 28 Plasma Asparaginase Activity (PAA) ≥ 0.1 U/mL
|
18 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Pre-dose, post-dose (sum of 14 and 25 days post-dose)Population: The immunogenicity analyses were carried out in the Immunogenicity Analysis Set (IAS) which includes all patients who had received at least one dose of IMP and had at least one post-dose sample evaluable for immunogenicity testing.
Anti-drug antibodies (ADA) formation against S95014 and anti-PEG with the lyophilized or liquid formulations (positive patients).
Outcome measures
| Measure |
S95014 Lyophilizate
n=43 Participants
Lyophilized S95014 reconstituted will provide 5 mL of extractable volume with the concentration of 750 U/mL. The vial of lyophilized powder (3.750 U/vial) is reconstituted with 5.2 mL of Sterile Water for Injection to obtain a 750 U/mL solution for single use.
Lyophilized S95014: Lyophilized S95014 will be intravenously administered over 1 hour at the dose of 2500 U/m2 at Day 3 of the induction phase.
Patients will receive other backbone chemotherapy agents as per ALL-MB 2015 protocol.
|
S95014 Liquid
n=43 Participants
Liquid S95014 is provided as 3.750 U per 5 mL solution in a single use vial to obtain a 750 U/mL solution for single use.
Liquid S95014: Liquid S95014 will be intravenously administered over 1 hour at the dose of 2500 U/m2 at Day 3 of the induction phase.
Patients will receive other backbone chemotherapy agents as per ALL-MB 2015 protocol.
|
|---|---|---|
|
Immunogenicity Measurements
Pre-dose · Anti-S95014 Negative/ Anti-PEG Not applicable
|
38 Participants
|
38 Participants
|
|
Immunogenicity Measurements
Pre-dose · Anti-S95014 Positive / Anti-PEG Positive
|
2 Participants
|
4 Participants
|
|
Immunogenicity Measurements
Pre-dose · Anti-S95014 Positive / Anti-PEG Negative
|
3 Participants
|
1 Participants
|
|
Immunogenicity Measurements
Post-dose (sum of 14 and 25 days post-dose) · Anti-S95014 Negative/ Anti-PEG Not applicable
|
38 Participants
|
39 Participants
|
|
Immunogenicity Measurements
Post-dose (sum of 14 and 25 days post-dose) · Anti-S95014 Positive / Anti-PEG Positive
|
2 Participants
|
3 Participants
|
|
Immunogenicity Measurements
Post-dose (sum of 14 and 25 days post-dose) · Anti-S95014 Positive / Anti-PEG Negative
|
3 Participants
|
1 Participants
|
Adverse Events
S95014 Lyophilizate
Serious events: 19 serious events
Other events: 43 other events
Deaths: 1 deaths
S95014 Liquid
Serious events: 18 serious events
Other events: 45 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
S95014 Lyophilizate
n=43 participants at risk
Lyophilized S95014 reconstituted will provide 5 mL of extractable volume with the concentration of 750 U/mL. The vial of lyophilized powder (3.750 U/vial) is reconstituted with 5.2 mL of Sterile Water for Injection to obtain a 750 U/mL solution for single use.
Lyophilized S95014: Lyophilized S95014 will be intravenously administered over 1 hour at the dose of 2500 U/m2 at Day 3 of the induction phase.
Patients will receive other backbone chemotherapy agents as per ALL-MB 2015 protocol.
|
S95014 Liquid
n=45 participants at risk
Liquid S95014 is provided as 3.750 U per 5 mL solution in a single use vial to obtain a 750 U/mL solution for single use.
Liquid S95014: Liquid S95014 will be intravenously administered over 1 hour at the dose of 2500 U/m2 at Day 3 of the induction phase.
Patients will receive other backbone chemotherapy agents as per ALL-MB 2015 protocol.
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
4.7%
2/43 • Number of events 2 • The period of time over which adverse event data were collected was1,5 month.
|
2.2%
1/45 • Number of events 1 • The period of time over which adverse event data were collected was1,5 month.
|
|
Infections and infestations
Sepsis
|
4.7%
2/43 • Number of events 2 • The period of time over which adverse event data were collected was1,5 month.
|
2.2%
1/45 • Number of events 1 • The period of time over which adverse event data were collected was1,5 month.
|
|
Infections and infestations
Appendicitis
|
2.3%
1/43 • Number of events 1 • The period of time over which adverse event data were collected was1,5 month.
|
0.00%
0/45 • The period of time over which adverse event data were collected was1,5 month.
|
|
Infections and infestations
Candida pneumonia
|
2.3%
1/43 • Number of events 1 • The period of time over which adverse event data were collected was1,5 month.
|
0.00%
0/45 • The period of time over which adverse event data were collected was1,5 month.
|
|
Infections and infestations
COVID-19
|
2.3%
1/43 • Number of events 1 • The period of time over which adverse event data were collected was1,5 month.
|
0.00%
0/45 • The period of time over which adverse event data were collected was1,5 month.
|
|
Infections and infestations
Gastroenteritis norovirus
|
2.3%
1/43 • Number of events 1 • The period of time over which adverse event data were collected was1,5 month.
|
0.00%
0/45 • The period of time over which adverse event data were collected was1,5 month.
|
|
Infections and infestations
Gastrointestinal bacterial infection
|
2.3%
1/43 • Number of events 1 • The period of time over which adverse event data were collected was1,5 month.
|
0.00%
0/45 • The period of time over which adverse event data were collected was1,5 month.
|
|
Infections and infestations
Neutropenic sepsis
|
2.3%
1/43 • Number of events 1 • The period of time over which adverse event data were collected was1,5 month.
|
0.00%
0/45 • The period of time over which adverse event data were collected was1,5 month.
|
|
Infections and infestations
Pseudomembranous colitis
|
2.3%
1/43 • Number of events 1 • The period of time over which adverse event data were collected was1,5 month.
|
0.00%
0/45 • The period of time over which adverse event data were collected was1,5 month.
|
|
Infections and infestations
Septic shock
|
0.00%
0/43 • The period of time over which adverse event data were collected was1,5 month.
|
2.2%
1/45 • Number of events 1 • The period of time over which adverse event data were collected was1,5 month.
|
|
General disorders
Multiple organ dysfunction syndrome
|
2.3%
1/43 • Number of events 1 • The period of time over which adverse event data were collected was1,5 month.
|
4.4%
2/45 • Number of events 2 • The period of time over which adverse event data were collected was1,5 month.
|
|
General disorders
Catheter site thrombosis
|
0.00%
0/43 • The period of time over which adverse event data were collected was1,5 month.
|
2.2%
1/45 • Number of events 1 • The period of time over which adverse event data were collected was1,5 month.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/43 • The period of time over which adverse event data were collected was1,5 month.
|
2.2%
1/45 • Number of events 1 • The period of time over which adverse event data were collected was1,5 month.
|
|
Nervous system disorders
Brain stem stroke
|
0.00%
0/43 • The period of time over which adverse event data were collected was1,5 month.
|
2.2%
1/45 • Number of events 1 • The period of time over which adverse event data were collected was1,5 month.
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
2.3%
1/43 • Number of events 1 • The period of time over which adverse event data were collected was1,5 month.
|
0.00%
0/45 • The period of time over which adverse event data were collected was1,5 month.
|
|
Nervous system disorders
Seizure
|
0.00%
0/43 • The period of time over which adverse event data were collected was1,5 month.
|
2.2%
1/45 • Number of events 1 • The period of time over which adverse event data were collected was1,5 month.
|
|
Nervous system disorders
Tonic convulsion
|
0.00%
0/43 • The period of time over which adverse event data were collected was1,5 month.
|
2.2%
1/45 • Number of events 1 • The period of time over which adverse event data were collected was1,5 month.
|
|
Hepatobiliary disorders
Hyperbilirubinemia
|
4.7%
2/43 • Number of events 2 • The period of time over which adverse event data were collected was1,5 month.
|
0.00%
0/45 • The period of time over which adverse event data were collected was1,5 month.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.0%
3/43 • Number of events 3 • The period of time over which adverse event data were collected was1,5 month.
|
11.1%
5/45 • Number of events 5 • The period of time over which adverse event data were collected was1,5 month.
|
|
Blood and lymphatic system disorders
Leukopenia
|
9.3%
4/43 • Number of events 4 • The period of time over which adverse event data were collected was1,5 month.
|
8.9%
4/45 • Number of events 4 • The period of time over which adverse event data were collected was1,5 month.
|
|
Blood and lymphatic system disorders
Hypofibrinogenemia
|
2.3%
1/43 • Number of events 1 • The period of time over which adverse event data were collected was1,5 month.
|
2.2%
1/45 • Number of events 1 • The period of time over which adverse event data were collected was1,5 month.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
2.3%
1/43 • Number of events 1 • The period of time over which adverse event data were collected was1,5 month.
|
2.2%
1/45 • Number of events 1 • The period of time over which adverse event data were collected was1,5 month.
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.7%
2/43 • Number of events 2 • The period of time over which adverse event data were collected was1,5 month.
|
0.00%
0/45 • The period of time over which adverse event data were collected was1,5 month.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/43 • The period of time over which adverse event data were collected was1,5 month.
|
2.2%
1/45 • Number of events 1 • The period of time over which adverse event data were collected was1,5 month.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.3%
1/43 • Number of events 1 • The period of time over which adverse event data were collected was1,5 month.
|
0.00%
0/45 • The period of time over which adverse event data were collected was1,5 month.
|
|
Investigations
Lymphocyte count decreased
|
7.0%
3/43 • Number of events 3 • The period of time over which adverse event data were collected was1,5 month.
|
8.9%
4/45 • Number of events 4 • The period of time over which adverse event data were collected was1,5 month.
|
|
Investigations
White blood cell count decreased
|
9.3%
4/43 • Number of events 4 • The period of time over which adverse event data were collected was1,5 month.
|
4.4%
2/45 • Number of events 2 • The period of time over which adverse event data were collected was1,5 month.
|
|
Investigations
Antithrombin III decreased
|
4.7%
2/43 • Number of events 2 • The period of time over which adverse event data were collected was1,5 month.
|
2.2%
1/45 • Number of events 1 • The period of time over which adverse event data were collected was1,5 month.
|
|
Investigations
Blood fibrinogen decreased
|
4.7%
2/43 • Number of events 2 • The period of time over which adverse event data were collected was1,5 month.
|
2.2%
1/45 • Number of events 1 • The period of time over which adverse event data were collected was1,5 month.
|
|
Investigations
ALT increased
|
2.3%
1/43 • Number of events 1 • The period of time over which adverse event data were collected was1,5 month.
|
0.00%
0/45 • The period of time over which adverse event data were collected was1,5 month.
|
|
Investigations
AST increased
|
2.3%
1/43 • Number of events 1 • The period of time over which adverse event data were collected was1,5 month.
|
0.00%
0/45 • The period of time over which adverse event data were collected was1,5 month.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/43 • The period of time over which adverse event data were collected was1,5 month.
|
2.2%
1/45 • Number of events 1 • The period of time over which adverse event data were collected was1,5 month.
|
|
Investigations
Neutrophil count decreased
|
2.3%
1/43 • Number of events 1 • The period of time over which adverse event data were collected was1,5 month.
|
0.00%
0/45 • The period of time over which adverse event data were collected was1,5 month.
|
|
Investigations
Platelet count decreased
|
0.00%
0/43 • The period of time over which adverse event data were collected was1,5 month.
|
2.2%
1/45 • Number of events 1 • The period of time over which adverse event data were collected was1,5 month.
|
|
Investigations
Protein S decreased
|
2.3%
1/43 • Number of events 1 • The period of time over which adverse event data were collected was1,5 month.
|
0.00%
0/45 • The period of time over which adverse event data were collected was1,5 month.
|
|
Gastrointestinal disorders
Neutropenic colitis
|
7.0%
3/43 • Number of events 3 • The period of time over which adverse event data were collected was1,5 month.
|
8.9%
4/45 • Number of events 4 • The period of time over which adverse event data were collected was1,5 month.
|
|
Gastrointestinal disorders
Edematous pancreatitis
|
4.7%
2/43 • Number of events 2 • The period of time over which adverse event data were collected was1,5 month.
|
0.00%
0/45 • The period of time over which adverse event data were collected was1,5 month.
|
|
Gastrointestinal disorders
Enterocolitis hemorrhagic
|
0.00%
0/43 • The period of time over which adverse event data were collected was1,5 month.
|
2.2%
1/45 • Number of events 1 • The period of time over which adverse event data were collected was1,5 month.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
2.3%
1/43 • Number of events 1 • The period of time over which adverse event data were collected was1,5 month.
|
0.00%
0/45 • The period of time over which adverse event data were collected was1,5 month.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/43 • The period of time over which adverse event data were collected was1,5 month.
|
2.2%
1/45 • Number of events 1 • The period of time over which adverse event data were collected was1,5 month.
|
|
Hepatobiliary disorders
Hepatosplenomegaly
|
2.3%
1/43 • Number of events 1 • The period of time over which adverse event data were collected was1,5 month.
|
0.00%
0/45 • The period of time over which adverse event data were collected was1,5 month.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
2.3%
1/43 • Number of events 1 • The period of time over which adverse event data were collected was1,5 month.
|
0.00%
0/45 • The period of time over which adverse event data were collected was1,5 month.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/43 • The period of time over which adverse event data were collected was1,5 month.
|
2.2%
1/45 • Number of events 1 • The period of time over which adverse event data were collected was1,5 month.
|
|
Injury, poisoning and procedural complications
Post procedural hemorrhage
|
2.3%
1/43 • Number of events 1 • The period of time over which adverse event data were collected was1,5 month.
|
0.00%
0/45 • The period of time over which adverse event data were collected was1,5 month.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/43 • The period of time over which adverse event data were collected was1,5 month.
|
2.2%
1/45 • Number of events 1 • The period of time over which adverse event data were collected was1,5 month.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
2.3%
1/43 • Number of events 1 • The period of time over which adverse event data were collected was1,5 month.
|
0.00%
0/45 • The period of time over which adverse event data were collected was1,5 month.
|
|
Vascular disorders
Pelvic Venous Thrombosis
|
2.3%
1/43 • Number of events 1 • The period of time over which adverse event data were collected was1,5 month.
|
0.00%
0/45 • The period of time over which adverse event data were collected was1,5 month.
|
Other adverse events
| Measure |
S95014 Lyophilizate
n=43 participants at risk
Lyophilized S95014 reconstituted will provide 5 mL of extractable volume with the concentration of 750 U/mL. The vial of lyophilized powder (3.750 U/vial) is reconstituted with 5.2 mL of Sterile Water for Injection to obtain a 750 U/mL solution for single use.
Lyophilized S95014: Lyophilized S95014 will be intravenously administered over 1 hour at the dose of 2500 U/m2 at Day 3 of the induction phase.
Patients will receive other backbone chemotherapy agents as per ALL-MB 2015 protocol.
|
S95014 Liquid
n=45 participants at risk
Liquid S95014 is provided as 3.750 U per 5 mL solution in a single use vial to obtain a 750 U/mL solution for single use.
Liquid S95014: Liquid S95014 will be intravenously administered over 1 hour at the dose of 2500 U/m2 at Day 3 of the induction phase.
Patients will receive other backbone chemotherapy agents as per ALL-MB 2015 protocol.
|
|---|---|---|
|
Investigations
Blood fibrinogen decreased
|
81.4%
35/43 • Number of events 35 • The period of time over which adverse event data were collected was1,5 month.
|
84.4%
38/45 • Number of events 40 • The period of time over which adverse event data were collected was1,5 month.
|
|
Investigations
Antithrombin III decreased
|
74.4%
32/43 • Number of events 33 • The period of time over which adverse event data were collected was1,5 month.
|
71.1%
32/45 • Number of events 32 • The period of time over which adverse event data were collected was1,5 month.
|
|
Investigations
Lymphocyte count decreased
|
74.4%
32/43 • Number of events 34 • The period of time over which adverse event data were collected was1,5 month.
|
60.0%
27/45 • Number of events 33 • The period of time over which adverse event data were collected was1,5 month.
|
|
Investigations
White blood cell count decreased
|
44.2%
19/43 • Number of events 19 • The period of time over which adverse event data were collected was1,5 month.
|
33.3%
15/45 • Number of events 15 • The period of time over which adverse event data were collected was1,5 month.
|
|
Blood and lymphatic system disorders
Leukopenia
|
37.2%
16/43 • Number of events 16 • The period of time over which adverse event data were collected was1,5 month.
|
26.7%
12/45 • Number of events 12 • The period of time over which adverse event data were collected was1,5 month.
|
|
Investigations
Alanine aminotransferase increased
|
20.9%
9/43 • Number of events 10 • The period of time over which adverse event data were collected was1,5 month.
|
37.8%
17/45 • Number of events 18 • The period of time over which adverse event data were collected was1,5 month.
|
|
Blood and lymphatic system disorders
Anemia
|
23.3%
10/43 • Number of events 10 • The period of time over which adverse event data were collected was1,5 month.
|
35.6%
16/45 • Number of events 17 • The period of time over which adverse event data were collected was1,5 month.
|
|
Investigations
Blood bilirubin increased
|
30.2%
13/43 • Number of events 14 • The period of time over which adverse event data were collected was1,5 month.
|
26.7%
12/45 • Number of events 12 • The period of time over which adverse event data were collected was1,5 month.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
20.9%
9/43 • Number of events 9 • The period of time over which adverse event data were collected was1,5 month.
|
28.9%
13/45 • Number of events 13 • The period of time over which adverse event data were collected was1,5 month.
|
|
Investigations
Protein S decreased
|
23.3%
10/43 • Number of events 10 • The period of time over which adverse event data were collected was1,5 month.
|
20.0%
9/45 • Number of events 9 • The period of time over which adverse event data were collected was1,5 month.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
23.3%
10/43 • Number of events 10 • The period of time over which adverse event data were collected was1,5 month.
|
17.8%
8/45 • Number of events 9 • The period of time over which adverse event data were collected was1,5 month.
|
|
Investigations
Aspartate aminotransferase increased
|
16.3%
7/43 • Number of events 7 • The period of time over which adverse event data were collected was1,5 month.
|
22.2%
10/45 • Number of events 10 • The period of time over which adverse event data were collected was1,5 month.
|
|
Nervous system disorders
Toxic neuropathy
|
25.6%
11/43 • Number of events 11 • The period of time over which adverse event data were collected was1,5 month.
|
13.3%
6/45 • Number of events 6 • The period of time over which adverse event data were collected was1,5 month.
|
|
Blood and lymphatic system disorders
Neutropenia
|
18.6%
8/43 • Number of events 8 • The period of time over which adverse event data were collected was1,5 month.
|
17.8%
8/45 • Number of events 10 • The period of time over which adverse event data were collected was1,5 month.
|
|
Investigations
Ammonia increased
|
11.6%
5/43 • Number of events 5 • The period of time over which adverse event data were collected was1,5 month.
|
13.3%
6/45 • Number of events 6 • The period of time over which adverse event data were collected was1,5 month.
|
|
Investigations
Gamma-glutamyltransferase increased
|
9.3%
4/43 • Number of events 4 • The period of time over which adverse event data were collected was1,5 month.
|
15.6%
7/45 • Number of events 7 • The period of time over which adverse event data were collected was1,5 month.
|
|
Gastrointestinal disorders
Neutropenic colitis
|
14.0%
6/43 • Number of events 6 • The period of time over which adverse event data were collected was1,5 month.
|
8.9%
4/45 • Number of events 4 • The period of time over which adverse event data were collected was1,5 month.
|
|
Gastrointestinal disorders
Stomatitis
|
11.6%
5/43 • Number of events 5 • The period of time over which adverse event data were collected was1,5 month.
|
11.1%
5/45 • Number of events 5 • The period of time over which adverse event data were collected was1,5 month.
|
|
Blood and lymphatic system disorders
Hypofibrinogenemia
|
11.6%
5/43 • Number of events 6 • The period of time over which adverse event data were collected was1,5 month.
|
8.9%
4/45 • Number of events 4 • The period of time over which adverse event data were collected was1,5 month.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
7.0%
3/43 • Number of events 3 • The period of time over which adverse event data were collected was1,5 month.
|
13.3%
6/45 • Number of events 6 • The period of time over which adverse event data were collected was1,5 month.
|
|
Investigations
Platelet count decreased
|
9.3%
4/43 • Number of events 4 • The period of time over which adverse event data were collected was1,5 month.
|
11.1%
5/45 • Number of events 5 • The period of time over which adverse event data were collected was1,5 month.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
11.6%
5/43 • Number of events 5 • The period of time over which adverse event data were collected was1,5 month.
|
4.4%
2/45 • Number of events 2 • The period of time over which adverse event data were collected was1,5 month.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
11.6%
5/43 • Number of events 5 • The period of time over which adverse event data were collected was1,5 month.
|
2.2%
1/45 • Number of events 1 • The period of time over which adverse event data were collected was1,5 month.
|
|
Investigations
Blood albumin decreased
|
4.7%
2/43 • Number of events 2 • The period of time over which adverse event data were collected was1,5 month.
|
8.9%
4/45 • Number of events 4 • The period of time over which adverse event data were collected was1,5 month.
|
|
Gastrointestinal disorders
Diarrhea
|
9.3%
4/43 • Number of events 4 • The period of time over which adverse event data were collected was1,5 month.
|
4.4%
2/45 • Number of events 2 • The period of time over which adverse event data were collected was1,5 month.
|
|
Investigations
Neutrophil count decreased
|
7.0%
3/43 • Number of events 3 • The period of time over which adverse event data were collected was1,5 month.
|
6.7%
3/45 • Number of events 4 • The period of time over which adverse event data were collected was1,5 month.
|
|
Hepatobiliary disorders
Hyperbilirubinemia
|
9.3%
4/43 • Number of events 7 • The period of time over which adverse event data were collected was1,5 month.
|
2.2%
1/45 • Number of events 1 • The period of time over which adverse event data were collected was1,5 month.
|
|
Investigations
International normalized ratio increased
|
7.0%
3/43 • Number of events 3 • The period of time over which adverse event data were collected was1,5 month.
|
4.4%
2/45 • Number of events 2 • The period of time over which adverse event data were collected was1,5 month.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.0%
3/43 • Number of events 3 • The period of time over which adverse event data were collected was1,5 month.
|
2.2%
1/45 • Number of events 1 • The period of time over which adverse event data were collected was1,5 month.
|
|
Investigations
Blood urea increased
|
7.0%
3/43 • Number of events 4 • The period of time over which adverse event data were collected was1,5 month.
|
2.2%
1/45 • Number of events 1 • The period of time over which adverse event data were collected was1,5 month.
|
|
Investigations
Hemoglobin decreased
|
2.3%
1/43 • Number of events 1 • The period of time over which adverse event data were collected was1,5 month.
|
6.7%
3/45 • Number of events 3 • The period of time over which adverse event data were collected was1,5 month.
|
|
Nervous system disorders
Neuropathy peripheral
|
7.0%
3/43 • Number of events 3 • The period of time over which adverse event data were collected was1,5 month.
|
2.2%
1/45 • Number of events 1 • The period of time over which adverse event data were collected was1,5 month.
|
|
Nervous system disorders
Headache
|
7.0%
3/43 • Number of events 3 • The period of time over which adverse event data were collected was1,5 month.
|
0.00%
0/45 • The period of time over which adverse event data were collected was1,5 month.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
7.0%
3/43 • Number of events 3 • The period of time over which adverse event data were collected was1,5 month.
|
0.00%
0/45 • The period of time over which adverse event data were collected was1,5 month.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
7.0%
3/43 • Number of events 3 • The period of time over which adverse event data were collected was1,5 month.
|
11.1%
5/45 • Number of events 5 • The period of time over which adverse event data were collected was1,5 month.
|
Additional Information
Therapeutic Area in Oncology
Institut de Recherches Internationales Servier
Phone: +33155724366
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER