Skip to content
Find Clinical Trials
Home » Find Clinical Trials » A Roll-over Study to Provide Continued Treatment With Lyophilized Pegaspargase (S95014) in Pediatric Patients With Acute Lymphoblastic Leukemia (ALL) (ALL)

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

Share Print
Servier Protocol Code: CL2-95014-003 Sponsor: Institut de Recherches Internationales Servier Clinicaltrials.gov Identifier: NCT04956666 EudraCT Number: 2020-004895-17

Find a recruiting site

How to participate to the 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 don’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 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.

Official title: A Multicentre, Roll-over Study to Provide Continued Treatment With Lyophilized Pegaspargase (S95014) in Pediatric Patients With Acute Lymphoblastic Leukemia (ALL)
Results
English (USA)
Русский (Россия)
English (USA)
Conditions
Acute Lymphoblastic Leukemia
Interventions / Treatments
  • Lyophilized S95014
Other study id numbers
  • CL2-95014-003

Eligibility Criteria

Eligible age for the study

1 year to 17 years (Child)

Sexes

Male/Female

Accepts Healthy Volunteers

No

To 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?

Allocation
N/A
Interventional study model
Single Group
Participant Group / Arm
Experimental: Freeze-dried S95014
Intervention / Treatment
Drug: Freeze-dried S95014

Participants received S95014 every 2 weeks through infusion into a vein. Participants also received other chemotherapy drugs according to the treatment plan.

Keywords

Provided by Servier
Acute Lymphoblastic Leukemia Phase II Oncology / Haematology Continued treatment Pegaspargase Lyophilized pegaspargase Roll-over study / extension study
Additional Relevant MeSH Terms Glioma
Precursor Cell Lymphoblastic Leukemia-Lymphoma Neoplasms