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Erwinase for intramuscular injection 10000 use-results survey

Phase 4
Recruiting
Conditions
acute leukemia or malignant lymphoma (only in cases of hypersensitivity to L-asparaginase products)
Erwinase, acute leukemia, malignant lymphoma
Registration Number
JPRN-jRCT2031230366
Lead Sponsor
Osawa Mistuharu
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
180
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

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

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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