Clinical trial NCT04956666: A Roll-over Study to Provide Continued Treatment With Lyophilized Pegaspargase (S95014) in Pediatric Patients With Acute Lymphoblastic Leukemia (ALL)
Official title: A Multicentre, Roll-over Study to Provide Continued Treatment With Lyophilized Pegaspargase (S95014) in Pediatric Patients With Acute Lymphoblastic Leukemia (ALL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Lymphoblastic Leukemia
Keywords: Acute Lymphoblastic Leukemia
Phase II
Oncology / Haematology
Continued treatment
Pegaspargase
Lyophilized pegaspargase
Roll-over study / extension study
Lead sponsor: Servier
Sponsor class: INDUSTRY
Collaborators: name: ADIR, a Servier Group company
name: Les Laboratoires Servier (L.L.S), Russia
First posted: 2021-07-09
Enrollment: 75
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Adverse Events (AEs) (Safety and Tolerability)
timeFrame: Through study completion, approximately 19 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chelyabinsk
country: Russian Federation
facility: Regional Children Clinical Hospital
city: Ekaterinburg
country: Russian Federation
facility: Regional Children Clinical Hospital
city: Krasnodar
country: Russian Federation
facility: Children Regional Clinical Hospital
city: Moscow
country: Russian Federation
facility: Russian Children Clinical Hospital
city: Nizhny Novgorod
country: Russian Federation
facility: Regional Children Hospital
city: Saint Petersburg
country: Russian Federation
facility: V.A. Almazov National Medical Research Center
Study officials:
affiliation: Director of Institute of Oncology, Radiology and Nuclear Medicine. Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology
name: Alexander Isaakovich Karachunskiy, PhD
role: PRINCIPAL_INVESTIGATOR
References: