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SPARK-ALL: Calaspargase Pegol in Adults With ALL

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Servier Protocol Code: CL2-95015-001 Sponsor: Institut de Recherches Internationales Servier Clinicaltrials.gov Identifier: NCT04817761

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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 19 locations

Study description

This study is needed to test a drug called calaspargase pegol in patients with 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 common type of cancer diagnosed in children. This kind of leukemia is defined by the type of immature blood cells involved.

The study drug, calaspargase pegol, is an “asparaginase”. Asparaginases break down a substance in the blood called asparagine, which is one of the building blocks for proteins. Cancer cells in ALL need asparagine to survive. By breaking down asparagine, asparaginases like calaspargase pegol may stop the cancer cells from surviving and multiplying.

The main goal of the study is to check how safe and effective calaspargase pegol is in participants with ALL.

Official title: SPARK-ALL: A Multi-center, Open-label, Single-arm Phase 2/3 Trial Evaluating the Safety and Pharmacokinetics of Calaspargase Pegol for Treatment of Adults Aged 22 To >65 Years With Newly-diagnosed Philadelphia-negative ALL.
Conditions
Acute Lymphoblastic Leukemia
Interventions / Treatments
  • Calaspargase pegol (S95015)
Other study id numbers
  • CL2-95015-001

Eligibility Criteria

Eligible age for the study

22 years to 55 years (Adult)

Sex

Male/Female

Accepts Healthy Volunteers

No

To take part in the study, participants have to:

  • Be adults aged between 22 and 55 years old.
  • Have confirmed ALL.

Participants cannot take part in the study if they:

  • Have taken part in another clinical study within the 2 weeks before starting this study.
  • Have previously received chemotherapy (treatment with medicines) or radiotherapy (treatment with radiation) for their ALL.

How is the study designed?

Allocation
N/A
Interventional study model
Single Group
Participant Group / Arm
Experimental: Calaspargase pegol (S95015)
Intervention / Treatment
Drug: Calaspargase pegol (S95015)

Part 1: Participants receive S95015 at different doses based on their age and body mass index (BMI; based on weight and height). It will be given through a 2-hour IV (intravenous) infusion (slow injection into the vein) on specific days during different phases of treatment. Participants will receive premedication (acetaminophen, histamine-1 blocker, and corticosteroids) to prevent allergic reactions before receiving calaspargase pegol, along with other chemotherapy drugs according to the treatment plan in the CALGB 10403 protocol.

Part 2: Participants receive S95015 at different doses based on their age and BMI. Participants who are 55 years or older or have a BMI greater than 35 kg/m2 will no longer be included in Part 2.

Keywords

Provided by Servier
Acute Lymphoblastic Leukemia ALL Ph-negative B-cell and T cell ALL Philadelphia-negative ALL Calaspargase Pegol Asparlas Adult Acute Lymphocytic Leukemia Newly diagnosed ALL Untreated ALL
Additional Relevant MeSH Terms Glioma
Precursor Cell Lymphoblastic Leukemia-Lymphoma Precursor T-Cell Lymphoblastic Leukemia-Lymphoma