Erwinase for intramuscular injection 10000 use-results survey

JRCT ID: jRCT2031230366

Registered date:27/09/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: acute leukemia or malignant lymphoma (only in cases of hypersensitivity to L-asparaginase products)
• Date of first enrollment: 27/09/2023
• Target sample size: 180
• Study type: Observational

Outcome(s)

• Primary Outcome: Safety (incidence of side effects, etc.)
• Secondary Outcome: antitumor effect

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients who fall under either of the following 1) or 2) and have been treated with this drug are eligible.
1) Patients with acute leukemia (including cases of acute conversion of chronic leukemia) or malignant lymphoma
However, only in cases of hypersensitivity to L-asparaginase products.
(2) Patients enrolled in a multicenter late phase II clinical trial for T-cell acute lymphoblastic leukemia in children, AYA generation and adults (JPLSG-ALL-T19) and a multicenter phase III clinical trial of multi-agent chemotherapy for B-precursor cell acute lymphocytic leukemia in children, AYA and adults (JPLSG-ALL -B19) enrolled patients.

Exclude criteria

1) Patients with a history of serious hypersensitivity to any ingredient of Irwinase for Intramuscular Injection 10000
(2) Patients with a history of serious pancreatitis caused by L-asparaginase products
3) Pregnant women or women who may be pregnant

Related Information

• Primary Sponsor: Osawa Mistuharu