Comparative Pharmacokinetics of a Compounded 6-mercaptopurine Liquid Formulation Preparation and Tablets

Children's Mercy Hospital Kansas City40 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Acute Lymphoblastic Leukemia

Interventions

6-MercaptopurineDRUG

75 mg/m2/dose/day

Eligibility

Sex: ALLMin age: 4 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (1)

The Children's Mercy Hospital

Kansas City, Missouri, United States

Outcomes

Primary Outcomes

Pharmacokinetics of 6-MP

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).

Time frame: 8 hours post administration

Data from ClinicalTrials.gov

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