CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 89 enrolled
Drug / intervention
Lyophilized S95014 +1 moredrug
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/NCT04954326
NCT04954326Phase 2Completed
CompareCT.gov

A Multicentre, Phase II Randomized Study, Open-label, With 2-arm Parallel Group, Comparing the Pharmacokinetics of the Liquid and the Lyophilized Formulations of Pegaspargase (S95014) in Treatment of Paediatric Patients With Newly-Diagnosed Acute Lymphoblastic Leukemia (ALL)

Institut de Recherches Internationales Servier·interventional·Posted Jul 8, 2021·Updated Jul 12, 2023

In Brief

A Phase 2 clinical trial evaluating Lyophilized S95014 and Liquid S95014 for Acute Lymphoblastic Leukemia. Completed, enrolled 89 participants across 6 sites.

Detailed Summary

The purpose of this study is to compare the pharmacokinetics (PK) of both lyophilized and liquid S95014 formulations during the induction phase after a single IV dose in newly diagnosed paediatric patients with ALL

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 8, 2021
Enrollment StartMay 7, 2021
Primary CompletionMay 20, 2022
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 5.0 years ago

Interventions

Lyophilized S95014drug

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.

Liquid S95014drug

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.