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

  • STATUS
    Recruiting
  • End date
    Nov 7, 2022
  • participants needed
    88
  • sponsor
    Institut de Recherches Internationales Servier
Updated on 12 May 2022

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.

Details
Condition Acute Lymphoblastic Leukemia
Treatment Lyophilized S95014
Clinical Study IdentifierNCT04956666
SponsorInstitut de Recherches Internationales Servier
Last Modified on12 May 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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