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

Information source: Children's Mercy Hospital Kansas City
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Lymphoblastic Leukemia

Intervention: 6-Mercaptopurine (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Children's Mercy Hospital Kansas City

Official(s) and/or principal investigator(s):
Kathleen A Neville, MD, MS, Principal Investigator, Affiliation: The Children's Mercy Hospitals and Clinics

Overall contact:
Sara J Soliman, BSN, Phone: 816-855-1977, Email: sjsoliman@cmh.edu

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).

Clinical Details

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

Study design: Observational Model: Case-Only, Time Perspective: Prospective

Primary outcome: Pharmacokinetics of 6-MP

Eligibility

Minimum age: 4 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

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 and Contacts

Sara J Soliman, BSN, Phone: 816-855-1977, Email: sjsoliman@cmh.edu

The Children's Mercy Hospital, Kansas City, Missouri 64108, United States; Recruiting
Michael Venneman, Phone: 816-234-3059, Email: mvenneman@cmh.edu
Kathleen A Neville, MD;MS, Phone: 816-234-3059, Email: kaneville@cmh.edu
Kathleen A Neville, MD:MS, Principal Investigator
Additional Information

Starting date: July 2011
Last updated: May 31, 2013

Page last updated: August 23, 2015

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