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

Sponsor
Children's Mercy Hospital Kansas City (Other)
Overall Status
Completed
CT.gov ID
NCT01324336
Collaborator
Midwest Cancer Alliance (Other)
40
Enrollment
1
Location
29
Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Actual Enrollment :
40 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Comparative Pharmacokinetics of a Compounded 6-mercaptopurine Liquid Formulation Preparation and Tablets
Study Start Date :
Jul 1, 2011
Actual Primary Completion Date :
Dec 1, 2013
Actual Study Completion Date :
Dec 1, 2013

Arms and Interventions

Arm Intervention/Treatment
4-17 years, receiving 6-MP

Drug: 6-Mercaptopurine
75 mg/m2/dose/day
Other Names:
  • 6-MP

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetics of 6-MP [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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    4 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Children's Mercy Hospital Kansas City Missouri United States 64108

    Sponsors and Collaborators

    • Children's Mercy Hospital Kansas City
    • Midwest Cancer Alliance

    Investigators

    • Principal Investigator: Kathleen A Neville, MD, MS, The Children's Mercy Hospitals and Clinics

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Children's Mercy Hospital Kansas City
    ClinicalTrials.gov Identifier:
    NCT01324336
    Other Study ID Numbers:
    • 6-MP pharmacokinetic 1
    First Posted:
    Mar 29, 2011
    Last Update Posted:
    Jan 5, 2021
    Last Verified:
    Dec 1, 2020
    Keywords provided by Children's Mercy Hospital Kansas City
    ALL
    acute lymphoblastic leukemia
    6-Mercaptopurine
    Pediatric
    Additional relevant MeSH terms:
    Precursor Cell Lymphoblastic Leukemia-Lymphoma
    Leukemia, Lymphoid
    Mercaptopurine

    Study Results

    No Results Posted as of Jan 5, 2021