Erwinase for intramuscular injection 10000 use-results survey

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT2031230366

Enrollment

180

Registered

2023-09-27

Start date

2023-09-27

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute leukemia or malignant lymphoma (only in cases of hypersensitivity to L-asparaginase products) Erwinase, acute leukemia, malignant lymphoma

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
Safety (incidence of side effects, etc.)	—

Secondary

Measure	Time frame
antitumor effect	—

Contacts

Public ContactMitsuharu Osawa

OHARA Pharmaceutical Co., Ltd.

mitsuharu-osawa@ohara-ch.co.jp+81-3-6740-7701

Outcome results