Acute Lymphoblastic Leukemia
Conditions
Keywords
ALL, acute lymphoblastic leukemia, 6-Mercaptopurine, Pediatric
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).
Interventions
DRUG6-Mercaptopurine
75 mg/m2/dose/day
Sponsors
Midwest Cancer Alliance
Children's Mercy Hospital Kansas City
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
4 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Outcome results
None listed