Comparative Pharmacokinetics of a Compounded 6-mercaptopurine Liquid Formulation Preparation and Tablets
1 other identifier
observational
40
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2011
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2011
CompletedFirst Posted
Study publicly available on registry
March 29, 2011
CompletedStudy Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedJanuary 5, 2021
December 1, 2020
2.4 years
March 25, 2011
December 30, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pharmacokinetics of 6-MP
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).
8 hours post administration
Study Arms (1)
4-17 years, receiving 6-MP
Interventions
Eligibility Criteria
Patients ages 4-17 years of age who are receiving maintenance chemotherapy treatment for ALL with 6-MP will be included
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Mercy Hospital Kansas Citylead
- Midwest Cancer Alliancecollaborator
Study Sites (1)
The Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
Biospecimen
whole blood, plasma
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kathleen A Neville, MD, MS
The Children's Mercy Hospitals and Clinics
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2011
First Posted
March 29, 2011
Study Start
July 1, 2011
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
January 5, 2021
Record last verified: 2020-12