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

Servier

Status and phase: Completed; Phase 2

Conditions: Acute Lymphoblastic Leukemia

Treatments: Drug: Lyophilized S95014

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04956666

2020-004895-17 (EudraCT Number)

CL2-95014-003

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 1 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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75 participants in 1 patient group

Lyophilized S95014

Experimental group

Description:

Lyophilized S95014 reconstituted was provided 5 mL of extractable volume with the concentration of 750 U/mL. The vial of lyophilized powder (3.750 U/vial) was reconstituted with 5.2 mL of Sterile Water For Injection to obtain a 750 U/mL solution for single use.

Treatment:

Drug: Lyophilized S95014