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

This study is currently recruiting participants.
Verified May 2013 by Children's Mercy Hospital Kansas City
Sponsor:
Collaborators:
Midwest Cancer Alliance
Experimental Therapeutics in Pediatric Oncology Program at The Children's Mercy Hospitals and Clinics
Information provided by (Responsible Party):
Kathleen A Neville, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT01324336
First received: March 25, 2011
Last updated: May 31, 2013
Last verified: May 2013

March 25, 2011
May 31, 2013
July 2011
December 2013   (final data collection date for primary outcome measure)
Pharmacokinetics of 6-MP [ Time Frame: 8 hours post administration ] [ Designated as safety issue: No ]
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).
Same as current
Complete list of historical versions of study NCT01324336 on ClinicalTrials.gov Archive Site
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Comparative Pharmacokinetics of a Compounded 6-mercaptopurine Liquid Formulation Preparation and Tablets
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).

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

whole blood, plasma

Non-Probability Sample

Patients ages 4-17 years of age who are receiving maintenance chemotherapy treatment for ALL with 6-MP will be included

Acute Lymphoblastic Leukemia
Drug: 6-Mercaptopurine
75 mg/m2/dose/day
Other Name: 6-MP
4-17 years, receiving 6-MP
Intervention: Drug: 6-Mercaptopurine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
Not Provided
December 2013   (final data collection date for primary outcome measure)

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
Both
4 Years to 17 Years
No
Contact: Sara J Soliman, BSN 816-855-1977 sjsoliman@cmh.edu
Contact: Michael Venneman, RN, MSN, MBA-HCM 816-234-3054 mvenneman@cmh.edu
United States
 
NCT01324336
6-MP pharmacokinetic 1
No
Kathleen A Neville, Children's Mercy Hospital Kansas City
Children's Mercy Hospital Kansas City
  • Midwest Cancer Alliance
  • Experimental Therapeutics in Pediatric Oncology Program at The Children's Mercy Hospitals and Clinics
Principal Investigator: Kathleen A Neville, MD, MS The Children's Mercy Hospitals and Clinics
Children's Mercy Hospital Kansas City
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP