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

Sponsor

Institut de Recherches Internationales Servier (Other)

Overall Status

Recruiting

CT.gov ID

NCT04956666

Collaborator

ADIR, a Servier Group company (Industry), Les Laboratoires Servier (L.L.S), Russia (Other)

Enrollment

Locations

Arm

16.8

Anticipated Duration (Months)

14.7

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acute Lymphoblastic Leukemia	Drug: Lyophilized S95014	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

88 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 15, 2021

Anticipated Primary Completion Date :

Nov 7, 2022

Anticipated Study Completion Date :

Nov 7, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lyophilized S95014 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.	Drug: Lyophilized S95014 Each patient will be 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 will be administrated (at week 7, 9, 11, 15, 17, 19, 23, 25 and 27).Patients will receive other backbone chemotherapy agents as per ALL-MB 2015.

Arm

Intervention/Treatment

Experimental: Lyophilized S95014

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.

Drug: Lyophilized S95014

Each patient will be 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 will be administrated (at week 7, 9, 11, 15, 17, 19, 23, 25 and 27).Patients will receive other backbone chemotherapy agents as per ALL-MB 2015.

Outcome Measures

Primary Outcome Measures

Incidence of Adverse Events (AEs) (safety and tolerability) [Through study completion, an average of 1 year]
All Adverse events (AEs) including Treatment Emergent Adverse Events (TEAEs) causality and severity based on NCI CTCAE 5.0.

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Regional Children Clinical Hospital	Chelyabinsk	Russian Federation	454087
2	Regional Children Clinical Hospital	Ekaterinburg	Russian Federation	620149
3	Children Regional Clinical Hospital	Krasnodar	Russian Federation	350007
4	Russian Children Clinical Hospital	Moscow	Russian Federation	119571
5	Regional Children Hospital	Nizhny Novgorod	Russian Federation	603136
6	V.A. Almazov National Medical Research Center	Saint Petersburg	Russian Federation	197341

Sponsors and Collaborators

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

Investigators

Principal Investigator: 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