Therapeutic drug monitoring of asparaginase and methotrexate metabolism in childhood acute lymphoblastic leukemia.

Therapeutic drug monitoring of asparaginase and methotrexate metabolism in childhood acute lymphoblastic leukemia. - Asparaginase and methotrexate in childhood acute lymphoblastic leukemia.

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON44473

Enrollment

Registered

2015-02-23

Start date

2015-03-03

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

Blood cancer leukemia

Interventions

None listed

Eligibility

Age

2 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Patients who are treated according to the DCOG ALL11 protocol. - Informed consent have to be signed by parents/guardians and patient of 12 years or older.

Exclusion criteria

Exclusion criteria: - Patients who have a contraindication for asparaginase. - Patients with hypersensitivity reactions to PEGasparaginase will switch to Erwinia asparaginase. These patients will be included in the population pharmacokinetic analysis up to the point a hypersensitivity reaction occurs. They will still remain included in the 3 other studies. - Patients who are stratified as high risk will be excluded from the methotrexate study.

Design outcomes

Primary

Measure	Time frame
The main study parameters are clearance, inter- and intra-patient variability in clearance and volume of distribution in the population pharmacokinetics study, difference in intracellular MTX polyglutamate concentration and toxicity in the MTX study, the difference in asparaginase toxicity profiles in the toxicity study and difference in costs in the cost analysis.	—

Secondary

Measure	Time frame
Not applicable.	—

Countries

Netherlands

Outcome results