A Study Comparing the Blood Levels of Both Pegaspargase (S95014) Formulations (Liquid vs Lyophilized) in the Treatment of Paediatric Patients With Acute Lymphoblastic Leukemia (ALL) (ALL)
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Study description
This study was done to compare 2 formulations of a drug called pegaspargase. One formulation was freeze-dried (or lyophilized, called here: LYO) and the other was a liquid formulation (called here: LIQ). This drug is approved in many countries for the treatment of Acute Lymphoblastic Leukemia (ALL).
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 immature 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 study was a phase 2 study. The main aim was to compare the activity of the 2 formulations of pegaspargase by measuring the blood “plasma asparaginase activity”.
- Lyophilized S95014
- Liquid S95014
- CL2-95014-002
Eligibility Criteria
Eligible age for the study
Sexes
Male/FemaleAccepts Healthy Volunteers
NoTo take part, participants had to:
- Have been diagnosed with ALL for the first time.
- Be between 1 and 18 years old.
- Be in good physical condition.
Participants could not take part in the study if they:
- Had previously received anticancer treatment with medicines (chemotherapy) or radiation (radiotherapy).
- Had previously undergone surgery or a bone marrow transplant for their ALL. Bone marrow is the spongy tissue inside bones where blood cells are made.
How is the study designed?
Participants received a single dose of pegaspargase by infusion (slow injection into a vein). The infusion lasted about 1 hour.
Participants received a single dose of pegaspargase by infusion into a vein. The infusion lasted about 1 hour.