Acute Lymphoblastic Leukemia
Conditions
Keywords
Acute Lymphoblastic Leukemia, Phase II, Oncology / Haematology, Continued treatment, Pegaspargase, Lyophilized pegaspargase, Roll-over study / extension study
Brief summary
The purpose of this study is to provide treatment with lyophilized S95014 in pediatric patients with ALL who completed the CL2-95014-002 study during the induction phase and who are clinically benefitting from S95014 without major toxicity.
Interventions
Each patient was administrated, over 1 to 2 hours, every 2 weeks Lyophilized S95014 intravenously at the dose of 1000, 2000 or 2500U/m2, as per investigator's judgement. In total, 9 infusions of lyophilized S95014 were administrated (at week 7, 9, 11, 15, 17, 19, 23, 25 and 27).Patients received other backbone chemotherapy agents as per ALL-MB 2015.
Sponsors
ADIR, a Servier Group company
Les Laboratoires Servier (L.L.S), Russia
Institut de Recherches Internationales Servier
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Patient who completed the CL2-95014-002 study * Patient currently receiving clinical benefit from previous treatment with S95014 as per investigator's judgment * Signed informed consent and assent, when appropriate * Highly effective contraception method Non-inclusion Criteria: * Unlikely to cooperate in the study * Pregnant and lactating women * Participant already enrolled in the study (informed consent signed) * Prior surgery or bone marrow transplant related to the studied disease * History of sensitivity to polyethylene glycol (PEG) or PEG-based drugs * Psychiatric illness/social situation that would limit compliance with study requirements * Group E and T-HR patients according to ALL-MB 2015 protocol classification * Major safety issue due to previous S95014 administration (e.g. non recovery of safety parameters, serious hypersensitivity, serious pancreatitis, serious haemorrhage, serious thromboembolic event) * Significant laboratory abnormality or uncontrolled intercurrent illness (e.g. life-threatening acute tumor lysis syndrome, symptomatic congestive heart failure, cardiac arrhythmia, severe or uncontrolled active acute infection) likely to jeopardize the patients' safety or to interfere with the conduct of the study, in the investigator's opinion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events (AEs) (Safety and Tolerability) | Through study completion, approximately 19 months | All Adverse events (AEs) including Treatment Emergent Adverse Events (TEAEs) causality and severity based on NCI CTCAE 5.0. |
Countries
Russia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lyophilized S95014 Lyophilized S95014 reconstituted was provided 5 mL of extractable volume with the concentration of 750 U/mL. | 74 |
| Total | 74 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 18 |
| Overall Study | Physician Decision | 5 |
Baseline characteristics
| Characteristic | Lyophilized S95014 |
|---|---|
| Age, Continuous | 6.1 years STANDARD_DEVIATION 3.83 |
| Age, Customized Age Category [10, 15] years | 12 Participants |
| Age, Customized Age Category < 10 years | 60 Participants |
| Age, Customized Age Category ≥ 16 years | 2 Participants |
| Body Mass Index (kg/m^2) | 16.45 kg/m^2 STANDARD_DEVIATION 3.51 |
| Body Surface Area (m^2) | 0.902 m^2 STANDARD_DEVIATION 0.356 |
| ECOG Performance Status ECOG Performance Status: 0 | 14 Participants |
| ECOG Performance Status ECOG Performance Status: 1 | 46 Participants |
| ECOG Performance Status ECOG Performance Status: 2 | 14 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 74 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized Race Asian | 2 Participants |
| Race/Ethnicity, Customized Race Multiple | 1 Participants |
| Race/Ethnicity, Customized Race White | 71 Participants |
| Sex: Female, Male Female | 36 Participants |
| Sex: Female, Male Male | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 74 |
| other Total, other adverse events | 68 / 74 |
| serious Total, serious adverse events | 27 / 74 |
Outcome results
Primary
Incidence of Adverse Events (AEs) (Safety and Tolerability)
All Adverse events (AEs) including Treatment Emergent Adverse Events (TEAEs) causality and severity based on NCI CTCAE 5.0.
Time frame: Through study completion, approximately 19 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Lyophilized S95014 | Incidence of Adverse Events (AEs) (Safety and Tolerability) | Number of Participants with a Grade 3 or 4 Treatment Emergent Adverse Event | 72 Participants |
| Lyophilized S95014 | Incidence of Adverse Events (AEs) (Safety and Tolerability) | Number of Participants with an Adverse Event | 74 Participants |
| Lyophilized S95014 | Incidence of Adverse Events (AEs) (Safety and Tolerability) | Number of Participants with an Treatment Emergent Adverse Event | 74 Participants |
| Lyophilized S95014 | Incidence of Adverse Events (AEs) (Safety and Tolerability) | Number of Participants with a Serious Treatment Emergent Adverse Event | 27 Participants |