Acute Lymphoblastic Leukemia
Conditions
Interventions
Pegaspargase
Sponsors
Kyowa Kirin Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy Percentage of patients who have a plasma asparaginase activity of more than 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
| Measure | Time frame |
|---|---|
| Safety Incidence and nature of treatment-emergent adverse events (TEAEs) and drug-related TEAEs. Efficacy Plasma Asparaginase Activity with therapeutic threshold of 0.1 IU/mL Asparaginase measured by coupled enzymatic activity assay. Survival rate at 1 year after the start of study treatment . Event-free survival rate at 1 year after the start of study treatment . | — |
Countries
Japan
Contacts
Public ContactNobuhiro Koga
Nihon Servier Company Limited Clinical Operation Department International Center for Therapeutic Research - Japan
Outcome results
None listed