Comparative Pharmacokinetics of a Compounded 6-mercaptopu... | NCT01324336

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

NCT01324336

Sponsor

Children's Mercy Hospital Kansas City

Status

Completed

Last Update Posted

Jan 5, 2021Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Acute Lymphoblastic Leukemia

Interventions

6-Mercaptopurine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Mar 25, 2011

First Submission Date that Met QC Criteria

Mar 28, 2011

First Posted Date

Mar 29, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 30, 2020

Last Update Posted Date

Jan 5, 2021Actual

Name	Class
Midwest Cancer Alliance	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
4-17 years, receiving 6-MP			Drug: 6-Mercaptopurine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
6-Mercaptopurine	Drug	75 mg/m2/dose/day	4-17 years, receiving 6-MP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kathleen A Neville, MD, MS	The Children's Mercy Hospitals and Clinics	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Children's Mercy Hospital		Kansas City	Missouri	64108	United States

Condition Browse Module

MeSH Terms

ID	Term
D054198	Precursor Cell Lymphoblastic Leukemia-Lymphoma

Ancestor Terms

ID	Term
D007945	Leukemia, Lymphoid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015122	Mercaptopurine

Ancestor Terms

ID	Term
D013438	Sulfhydryl Compounds
D013457	Sulfur Compounds
D009930	Organic Chemicals
D011687	Purines

Browse Leaves

Not provided

Browse Branches

Not provided