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A Clinical Study of SHP674 (Pegaspargase) in Participants With Newly Diagnosed, Untreated Acute Lymphoblastic Leukemia

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Servier Protocol Code: SHP674-201/CL1-95014-001 Sponsor: Institut de Recherches Internationales Servier Clinicaltrials.gov Identifier: NCT04067518

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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 8 locations

Study description

This study was done to support the approval of pegaspargase in Japan for paediatric population with acute lymphoblastic leukaemia (ALL). Pegaspargase has been already approved in many countries for 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 type of leukemia is defined by the origin of the immature blood cells that are involved.

The study drug is an asparaginase called pegaspargase. Asparaginases breakdown a substance in the blood called asparagine. The cancer cells in ALL need asparagine to survive. An asparaginase is already in used in Japan for ALL. Pegaspargase has been modified to reduce the risk of allergy and to improve the ability to stay in the body.  As a result, fewer doses of pegaspargase are needed.

This study was a phase II study and combined 2 parts: part 1 and part 2.

The main aims were:

  • For part 1, to test the safety of one dose of pegaspargase in Japanese children and adolescents.
  • For part 2, to check the activity of the drug by measuring the “plasma asparaginase activity” in blood, 14 days after the first injection.
Official title: A Phase 2 Clinical Study of SHP674 in Patients With Newly Diagnosed, Untreated Acute Lymphoblastic Leukemia
Results
English (USA)
日本語 (日本)
English (USA)
Conditions
Acute Lymphoblastic Leukemia
Interventions / Treatments
  • SHP674
Other study id numbers
  • SHP674-201/CL1-95014-001

Eligibility Criteria

Eligible age for the study

1 year to 21 years (Child, Adult)

Sexes

Male/Female

Accepts Healthy Volunteers

No

To take part, participants had to:

  • Be between 1 to 21 years old.
  • Be in good physical condition.
  • Have been newly diagnosed for ALL.
  • Never have been treated with anticancer drugs.

Participants could not take part in the study if they:

  • Had previously received treatment with an asparaginase.
  • Have or have had another cancer other than ALL.

How is the study designed?

Allocation
N/A
Interventional study model
Single Group
Participant Group / Arm
Experimental: SHP674

Each patient received the same treatment of pegaspargase in solution by injection into a vein.

Intervention / Treatment
Biological: SHP674

The dose of pegaspargase was determined according to the body surface area (BSA). The BSA was calculated using the participant’s height and weight:

  • in case of BSA more than 0.6 square meter (m2), the dose was of 2500 international units per m2 of BSA.
  • in case of BSA less than 0.6 m2, the dose was 82.5 IU per kg.

In addition, all participants received other drugs routinely used to treat this cancer.

Keywords

Provided by Servier
Acute Lymphoblastic Leukemia
Additional Relevant MeSH Terms Glioma
Precursor Cell Lymphoblastic Leukemia-Lymphoma