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

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).

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Key information

Conditions

Acute Lymphoblastic Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

6-Mercaptopurine

Drug

75 mg/m2/dose/day

Other names: 6-MP

Primary outcomes

Pharmacokinetics of 6-MP

Time frame: 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).

Sponsors and collaborators

Lead sponsor

Children's Mercy Hospital Kansas City

Other

Collaborators

Midwest Cancer Alliance

Registry information

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: Mar 29, 2011
Registry last updated: Jan 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed