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

Overview

The objectives of the study are to 1) assess the safety and tolerability of a single dose of Pegaspargase in Japanese patients (dose confirmation) in the tolerability assessment period; and 2) to assess the safety, pharmacokinetics and efficacy of Pegaspargase in the treatment of newly diagnosed untreated acute lymphoblastic leukemia in Japanese patients.

Full Title of Study: “A Phase 2 Clinical Study of Pegaspargase in Patients With Newly Diagnosed, Untreated Acute Lymphoblastic Leukemia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 3, 2021

Interventions

  • Biological: Pegaspargase
    • Pegaspargase : powder for solution for injection, IV (administered by 1 to 2 hours of drip infusion), dose determination : if BSA ≥0.6 m2: 2500 IU/m2 every 14 days if BSA <0.6 m2: 82.5 IU/kg every 14 days

Arms, Groups and Cohorts

  • Experimental: Pegaspargase arm

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of patients who have a plasma asparaginase activity of ≥0.1 IU/mL 14 days (336 hours) after the first dose of Pegaspargase
    • Time Frame: 14 days after the first dose of Pegaspargase in Remission Induction phase

Secondary Measures

  • Incidence and nature of treatment-emergent adverse events (TEAEs) and drug-related TEAEs
    • Time Frame: Up to 1 year
  • Plasma Asparaginase Activity with therapeutic threshold of 0.1 IU/mL Asparaginase measured by coupled enzymatic activity assay
    • Time Frame: Prior to, and including 11, 14, and 25 days after Pegaspargase administration
  • Survival rate at 1 year after the start of study treatment
    • Time Frame: 1 year after the start of study treatment
  • Event-free survival rate at 1 year after the start of study treatment
    • Time Frame: 1 year after the start of study treatment

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 1 Year

Maximum Age: 21 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Institut de Recherches Internationales Servier
  • Collaborator
    • Kyowa Kirin Co., Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Chitose Ogawa, MD, Principal Investigator, National Cancer Center Hospital, Tokyo JAPAN

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