Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04956666 | A Roll-over Study to Provide Continued Treatment With Lyophilized Pegaspargase (S95014) in Pediatric Patients With Acute Lymphoblastic Leukemia (ALL) | PHASE2 | COMPLETED | 75 | — | — | Jun 15, 2021 | Jan 23, 2023 | Dec 29, 2023 | 6 | Russia |
| NCT04954326 | 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) | PHASE2 | COMPLETED | 89 | — | — | May 7, 2021 | May 20, 2022 | Jul 12, 2023 | 6 | Russia |
All Adverse events (AEs) including Treatment Emergent Adverse Events (TEAEs) causality and severity based on NCI CTCAE 5.0.
Area Under the Plasma Asparaginase activity - Time curve from Time zero to infinity (AUCinf)
| Arm | Type | Description |
|---|---|---|
| Lyophilized S95014 | EXPERIMENTAL | Lyophilized S95014 reconstituted was provided 5 mL of extractable volume with the concentration of 750 U/mL. The vial of lyophilized powder (3.750 U/vial) was reconstituted with 5.2 mL of Sterile Water For Injection to obtain a 750 U/mL solution for single use. |
| S95014 lyophilizate | EXPERIMENTAL | 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. |
| S95014 liquid | ACTIVE_COMPARATOR | 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. |
| Name | Type | Description |
|---|---|---|
| Lyophilized S95014 | DRUG | 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. |
| Liquid S95014 | DRUG | 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. |
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 Criteri...