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

Children's Mercy Hospital Kansas City

Status: Completed

Conditions: Acute Lymphoblastic Leukemia

Treatments: Drug: 6-Mercaptopurine

Study type: Observational

Funder types: Other

Identifiers

NCT01324336

6-MP pharmacokinetic 1

Details and patient eligibility

About

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).

Enrollment: 40 patients

Sex: All

Ages: 4 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

40 participants in 1 patient group

4-17 years, receiving 6-MP

Treatment:

Drug: 6-Mercaptopurine