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NCT Number: NCT04067518

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

The objectives of the study are to assess the safety and tolerability of a single dose of SHP674 in Japanese participants (dose confirmation) in the tolerability assessment period of Part 1 and to assess the safety, pharmacokinetics and efficacy of SHP674 dose in Part 2 (found to be tolerated in Part 1) in the treatment of newly diagnosed untreated acute lymphoblastic leukemia (ALL) in Japanese participants.

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Key information

Conditions

Acute Lymphoblastic Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

1 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kagoshima University Hospital Department of Pediatrics, Kagoshima, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 1 to ≤21 years at the time of informed consent;
  • Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 2;
  • Newly diagnosed, untreated precursor B-cell ALL
  • No prior therapy for malignant tumor such as chemotherapy and radiation therapy before signing the informed consent;
  • Life expectancy of at least 6 months from the date of enrollment;

Exclusion criteria

  • Mature B-cell ALL ; Philadelphia chromosome-positive (Ph+) or BCR-ABL1-positive ALL
  • Preexisting known coagulopathy ;
  • History of pancreatitis;
  • Continuous use of corticosteroids;
  • Prior treatment or possible prior treatment with an L-asparaginase preparation;
  • History of sensitivity to polyethylene glycol (PEG) or PEG-based drugs;
  • Pregnant

Treatment and study plan

SHP674

Biological

SHP674: powder for solution for injection, IV (administered by 1 to 2 hours of drip infusion), dose determination : if BSA ≥0.6 m^2: 2500 IU/m^2 every 14 days if BSA <0.6 m^2: 82.5 IU/kg every 14 days

Other names: Pegaspargase

Primary outcomes

  1. Part 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and SHP-674-Related TEAEs During the Tolerability Assessment Period

    Time frame: Up to 30 days after last dose of study drug (approximately 49 weeks)

    An adverse event (AE) is defined as any untoward medical occurrence in a participant after signing informed consent. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease, whether or not it is related to the investigational product. TEAE is defined as any untoward medical occurrence in a participant who received an investigational product which occurs during the period from Day 1 of the pre-treatment phase to 30 (+7) days after the last dose of investigational product, or until the start of a new therapy, whichever occurs first. A related adverse event signifies that there is a reasonable causal relationship between study treatment and an AE.

  2. Part 2: Percentage of Participants Who Achieved a Plasma Asparaginase Activity of ≥0.1 International Units Per Milliliter (IU/mL) 14 Days (336 Hours) After the First Dose of SHP674

    Time frame: 14 days after the first dose of SHP674

Secondary outcomes

  1. Percentage of Participants With Anti-Drug (SHP674) Antibody (ADA) (Part 1 and Part 2)

    Time frame: Predose and 25 days post dose (Part 1 and Part 2)

  2. Percentage of Participants With Anti-Polyethylene Glycol (PEG) Antibody (Part 1 and Part 2)

    Time frame: Predose and 25 days post dose (Part 1 and part 2)

  3. Part 1: Percentage of Participants Who Achieved a Plasma Asparaginase Activity of ≥0.1 IU/mL 14 Days (336 Hours) After the First Dose of SHP674

    Time frame: 14 days after the first dose of SHP674

  4. Part 2: Percentage of Participants With Plasma Asparaginase Activity of ≥0.1 IU/mL or <0.1 IU/mL

    Time frame: Day 1 (pre-dose, 5 min, 4 hours, 24 hours post dose), Days 2, 4, 11, 14, 18, 25 post dose

  5. Survival Rate at 1 Year After the Start of Study Treatment

    Time frame: 1 year after the start of study treatment (from first dose up to 12 months)

    Survival rate is defined as the percentage of subjects who survived at 1 year after the start of study treatment.

  6. Event-free Survival Rate at 1 Year After the Start of Study Treatment

    Time frame: 1 year after the start of study treatment (from first dose up to 12 months)

    Event-free survival rate is defined as percentage of subjects who did not experience any event and survived at 1 year after the start of study treatment.

Sponsors and collaborators

Lead sponsor

Institut de Recherches Internationales Servier

Other

Collaborators

  • ADIR, a Servier Group company
  • Kyowa Kirin Co., Ltd.

Registry information

Official study title

A Phase 2 Clinical Study of SHP674 in Patients With Newly Diagnosed, Untreated Acute Lymphoblastic Leukemia

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Aug 26, 2019
Registry last updated
Apr 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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