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Home » Find Clinical Trials » 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)

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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Servier Protocol Code: CL2-95014-002 Sponsor: Institut de Recherches Internationales Servier Clinicaltrials.gov Identifier: NCT04954326 EudraCT Number: 2020-004894-29

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How to participate in this study
If you think you are eligible for this study (see
eligibility criteria
below), you can identify the location closest to you and contact them directly. If you can’t find a location close to you, please contact Institut de Recherches Internationales Servier (I.R.I.S.)
Name: Institut de Recherches Internationales Servier, Département des études cliniques
Phone number: +33 1 55 72 60 00
The study has 6 locations

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”.

Official title: A Multicentre, Phase II Randomized Study, Open-label, With 2-arm Parallel Group, Comparing the Pharmacokinetics of the Liquid and the Lyophilized Formulations of Pegaspargase (S95014) in Treatment of Paediatric Patients With Newly-Diagnosed Acute Lymphoblastic Leukemia (ALL)
Results
English (USA)
Русский (Россия)
English (USA)
Conditions
Acute Lymphoblastic Leukemia
Interventions / Treatments
  • Lyophilized S95014
  • Liquid S95014
Other study id numbers
  • CL2-95014-002

Eligibility Criteria

Eligible age for the study

1 year to 17 years (Child)

Sex

Male/Female

Accepts Healthy Volunteers

No

To 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?

Allocation
Randomized
Interventional study model
Parallel
Participant Group / Arm
Experimental: Freeze-dried S95014
Intervention / Treatment
Drug: Freeze-dried S95014

Participants received a single dose of pegaspargase by infusion (slow injection into a vein). The infusion lasted about 1 hour.

Participant Group / Arm
Active Comparator: Liquid S95014
Intervention / Treatment
Drug: Liquid S95014

Participants received a single dose of pegaspargase by infusion into a vein. The infusion lasted about 1 hour.

Keywords

Provided by Servier
Oncology / Haematology Phase II Acute Lymphoblastic Leukemia Parallel group Pegaspargase Pharmacokinetics comparability Lyophilized pegaspargase Liquid pegaspargase Pegaspargase formulation Randomized, open-label
Additional Relevant MeSH Terms Glioma
Precursor Cell Lymphoblastic Leukemia-Lymphoma Neoplasms