A prospective clinical study of the pharmacokinetics of pemesterase groups and the efficacy and safety of acute lymphoblastic leukaemia in children

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400080371

Enrollment

Unknown

Registered

2024-01-27

Start date

2024-02-01

Completion date

Unknown

Last updated

2024-01-28

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

Conditions

pediatric acute lymphoblastic leukemia

Interventions

population pharmacokinetics Group:Pegaspargase

Eligibility

Sex/Gender

All

Age

No minimum to 18 Years

Inclusion criteria

Inclusion criteria: (1) 1 month < age = 18 years, male or female. (2) Diagnosis of acute lymphoblastic leukaemia (T-ALL or B-ALL) confirmed by bone marrow cytomorphology and immunophenotyping, etc. (3) Parents or legal guardians signing the informed consent form for the study. (4) Patients enrolled to treat children according to the SCCLG-ALL-2016 protocol.

Exclusion criteria

Exclusion criteria: (1) Acute mixed phenotype leukaemia (excluding ALL with myeloid antigen expression). (2) ALL with Down's syndrome. (3) Acute lymphoblastic leukaemia of mature B-cell lineage (B-cell ALL). (4) Chronic myeloid leukemia (CML) as a second tumour, definite acute variant. (5) Secondary to an immunodeficiency disease. (6) Hypersensitivity to pemesterase. (7) Pre-existing pancreatitis. (8) Hepatic insufficiency (total bilirubin > 50umol/L; SGOT/SGPT > 10 times ULN). (9) Combined coagulation disorders (e.g. haemophilia, etc.).

Design outcomes

Primary

Measure	Time frame
trough level;clearance;AUC;Vd;	—

Countries

China

Contacts

Public ContactJunyan Wu, Dunhua Zhou

Sun yat-sen memorial hospital, Sun yat-sen university

wujunyan@mail.sysu.edu.cn+86 20 8133 2451

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026