Development and introduction of a pediatric liquid formulation of mercaptopurine for treatment of leukemia

Completed

• Conditions: acute lymphoblastic leukemia; leukemia; 10024324

• Registration Number: NL-OMON35236
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

- histologically or cytologically confirmed acute lymphatic leukemia
- inclusion in dcog all10 protocol or interfant 06
- available venous access port
- ALAT and ASAT <1000 IU/l
- written informed consent

Exclusion Criteria

- patient or parent refusal
- pre-existing liver disease

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Bioequivalence will be assessed by determining blood levels of the active<br /><br>metabolites of 6MP in red blood cells. Two-weekly leukocyte counts will be<br /><br>performed to monitor hematological toxicity. Compliance and acceptance of the<br /><br>different formulations by children and parents will be assessed by<br /><br>questionnaires. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Acceptation by the patient</p><br>