Evaluation of safety in the ethical use of erwininia L-asparaginase (erwinase) for patients with acute lymphoblastic leukemia and lymphoblastic lymphoma

Evaluation of safety in the ethical use of erwininia L-asparaginase (erwinase) for patients with acute lymphoblastic leukemia and lymphoblastic lymphoma - Evaluation of safety in the ethical use of erwininia L-asparaginase (erwinase)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007869

Enrollment

Registered

2012-05-01

Start date

2012-05-01

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 lymphoblastic leukemia, lymphoblastic lymphoma

Interventions

The use of the predefined dosage of erwinia L-asparaginase (erwinase)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Previously registered in the OP-01 trial. 2. The disease is in remission. 3. At least 14 days passed after the last administration of anticancer drugs. 4. Performance status equal or greater than 50 points. 5. No major visceral organ insufficiency.

Exclusion criteria

Exclusion criteria: 1. Patients who had adverse events with the previous use of erwinase. 2. Having the following complications: (1) Infection requiring systemic antibiotics. (2) Herat diseases. (3) Interstitial pneumonitis or pulmonary fibrosis (4) Down syndrome

Design outcomes

Primary

Measure	Time frame
The frequency and the severity of adverse events	—

Secondary

Measure	Time frame
The efficacy of the drug evaluating the remission status	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026