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

Acute Lymphoblastic Leukemia Clinical Trial

— ALL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04956666
• Other study ID #: CL2-95014-003
• Secondary ID: 2020-004895-17
• Status: Completed
• Phase: Phase 2
• Start date: June 15, 2021
• Est. completion date: January 23, 2023

Study information

• Verified date: December 2023
• Source: Servier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: January 23, 2023
• Est. primary completion date: January 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• Lyophilized S95014
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.

Locations

Country	Name	City	State
Russian Federation	Regional Children Clinical Hospital	Chelyabinsk
Russian Federation	Regional Children Clinical Hospital	Ekaterinburg
Russian Federation	Children Regional Clinical Hospital	Krasnodar
Russian Federation	Russian Children Clinical Hospital	Moscow
Russian Federation	Regional Children Hospital	Nizhny Novgorod
Russian Federation	V.A. Almazov National Medical Research Center	Saint Petersburg

Sponsors (3)

Lead Sponsor	Collaborator
Institut de Recherches Internationales Servier	ADIR, a Servier Group company, Les Laboratoires Servier (L.L.S), Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Through study completion, approximately 19 months

External Links

•   Find results on Servier Clinical Trial Data website