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


N/A
4 Years
17 Years
Open (Enrolling)
Both
Acute Lymphoblastic Leukemia

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Trial Information

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


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Pharmacokinetics of 6-MP

Outcome Description:

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).

Outcome Time Frame:

8 hours post administration

Safety Issue:

No

Principal Investigator

Kathleen A Neville, MD, MS

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Children's Mercy Hospitals and Clinics

Authority:

United States: Food and Drug Administration

Study ID:

6-MP pharmacokinetic 1

NCT ID:

NCT01324336

Start Date:

July 2011

Completion Date:

Related Keywords:

  • Acute Lymphoblastic Leukemia
  • ALL
  • acute lymphoblastic leukemia
  • 6-Mercaptopurine
  • Pediatric
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

Name

Location
The children's Mercy Hospital Kansas City, Missouri  64108