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

Phase 4

Completed

• Conditions: Blood cancer; leukemia; 10024324

• Registration Number: NL-OMON44473
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 70

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

- 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.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameters are clearance, inter- and intra-patient variability<br /><br>in clearance and volume of distribution in the population pharmacokinetics<br /><br>study, difference in intracellular MTX polyglutamate concentration and toxicity<br /><br>in the MTX study, the difference in asparaginase toxicity profiles in the<br /><br>toxicity study and difference in costs in the cost analysis.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable. </p><br>