CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 75 enrolled
Drug / intervention
Lyophilized S95014drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04956666
NCT04956666Phase 2Completed
CompareCT.gov

A Multicentre, Roll-over Study to Provide Continued Treatment With Lyophilized Pegaspargase (S95014) in Pediatric Patients With Acute Lymphoblastic Leukemia (ALL)

Institut de Recherches Internationales Servier·interventional·Posted Jul 9, 2021·Updated Dec 29, 2023

In Brief

A Phase 2 clinical trial evaluating Lyophilized S95014 for Acute Lymphoblastic Leukemia. Completed, enrolled 75 participants across 6 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Lymphoblastic Leukemia
CountriesRussia
CollaboratorsADIR, a Servier Group company, Les Laboratoires Servier (L.L.S), Russia

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedJul 9, 2021
Enrollment StartJun 15, 2021
Primary CompletionJan 23, 2023
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 5.0 years ago

Interventions

Lyophilized S95014drug

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.