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

Completed

Conditions studied: Acute Lymphoblastic Leukemia

In brief

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).

Key facts

Study ID

NCT01324336

Run by

Children's Mercy Hospital Kansas City

People needed

40

Starts

2011-07-01

Expected to finish

2013-12-01

Last updated by the study team

2021-01-05

Who can join

Age: 4 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients ages 4-17 years of age who are receiving maintenance chemotherapy treatment for ALL with 6-MP will be included.

You may not qualify if…

• 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

Where it is running

• The Children's Mercy Hospital — Kansas City, Missouri, United States

Full record on ClinicalTrials.gov

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