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

A Phase 2 Clinical Study of SHP674 in Patients 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.

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