Comparative Pharmacokinetics of a Compounded 6-mercaptopurine Liquid Formulation Preparation and Tablets
Information source: Children's Mercy Hospital Kansas City
Information obtained from ClinicalTrials.gov on February 07, 2013
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 Hospital
Overall contact:
Ann M Harris, RN, BSN, MBA, Phone: 816-234-3059, Email: amharris@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-Crossover, Time Perspective: Prospective
Primary outcome: Pharmacokinetics of 6-MP
Eligibility
Minimum age: 6 Years.
Maximum age: 17 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients ages 6-17 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
- Body-mass index (BMI) < 5th and > 95th percentile
- 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
Ann M Harris, RN, BSN, MBA, Phone: 816-234-3059, Email: amharris@cmh.edu
The Children's Mercy Hospital, Kansas City, Missouri 64108, United States; Recruiting
Ann M Harris, RN, BSN, MBA, Phone: 816-234-3059, Email: amharris@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: October 2010
Last updated: April 8, 2011
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