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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)

NCT04954326 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2023-07-12

Study results available
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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

Conditions

Interventions

DRUG

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.

DRUG

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.

Sponsors & Collaborators

  • ADIR, a Servier Group company

    collaborator INDUSTRY

  • Les Laboratoires Servier (L.L.S), Russia

    collaborator INDUSTRY

  • Institut de Recherches Internationales Servier

    lead OTHER

Principal Investigators

  • Alexander Isaakovich Karachunskiy, PhD · Director of Institute of Oncology, Radiology and Nuclear Medicine. Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-07
Primary Completion
2022-05-20
Completion
2022-05-20
FDA Drug
Yes

Countries

  • Russia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04954326 on ClinicalTrials.gov