A Roll-over Study to Provide Continued Treatment With Lyophilized Pegaspargase (S95014) in Pediatric Patients With Acute Lymphoblastic Leukemia (ALL) (ALL)
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Study description
This study was done to provide continued treatment with pegaspargase to participants with Acute Lymphobastic Leukemia (ALL) who completed a previous study called CL2-95014-002.
Leukemia is a cancer of the blood. When these cancers occur, abnormal white blood cells increase rapidly and uncontrollably. ALL is the most commonly diagnosed cancer in children. This kind of leukemia is defined by the type of the abnormal white blood cells that are involved.
The study drug is an “asparaginase” and is called pegaspargase. Asparaginases breakdown a substance in the blood called asparagine (one of the building blocks for proteins). The cancer cells in ALL need asparagine to survive. Pegaspargase has been modified to reduce the risk of allergy and to improve the ability to stay in the body. This is called freeze-dried pegaspargase.
The main aim was to provide participants of the study CL2-95014-002 continued treatment with freeze-dried pegaspargase as this treatment was not yet available in Russia.
English (USA)
Русский (Россия)- Lyophilized S95014
- CL2-95014-003
Eligibility Criteria
Eligible age for the study
Sex
Male/FemaleAccepts Healthy Volunteers
NoTo take part, participants had to:
- Have completed a previous study called CL2-95014-002.
- Have benefited from treatment with pegaspargase in the CL2-95014-002 study.
Participants could not take part in the study if they:
- Had previously experienced side effects after taking pegaspargase that they did not recover from or that were serious.
How is the study designed?
Participants received S95014 every 2 weeks through infusion into a vein. Participants also received other chemotherapy drugs according to the treatment plan.