Comparative Pharmacokinetics of a Compounded 6-mercaptopurine Liquid Formulation Preparation and Tablets
- Registration Number
- NCT01324336
- Lead Sponsor
- Children's Mercy Hospital Kansas City
- Brief Summary
The purpose of this study is to compare the pharmacokinetics of a routinely used compounded liquid formulation of 6-mercaptopurine (6-MP) with commercially available tablets in patients who are receiving treatment with 6-MP as part of their clinical treatment for acute lymphoblastic leukemia (ALL).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- Patients ages 4-17 years of age who are receiving maintenance chemotherapy treatment for ALL with 6-MP will be included.
Exclusion Criteria
- Inability to have blood drawn for the screening lab tests
- Received methotrexate or folate supplement within the last 24 hours
- Pregnant or lactating females
- Inability to swallow a pill
- Hemoglobin less or equal to 8 gm/dl
- Presence of significant co-morbid illness that makes child ineligible as deemed by the investigator
- Weight < or = 16 kg
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 4-17 years, receiving 6-MP 6-Mercaptopurine -
- Primary Outcome Measures
Name Time Method Pharmacokinetics of 6-MP 8 hours post administration To compare the pharmacokinetics of a routinely used compounded liquid formulation of 6-mercaptopurine (6-MP) with commercially available tablets in patients who are receiving treatment with 6-MP as part of their clinical treatment for acute lymphoblastic leukemia (ALL).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
The Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States