Acute Lymphoblastic LeukemiaNCT01324336
Comparative Pharmacokinetics of a Compounded 6-mercaptopurine Liquid Formulation Preparation and Tablets
An observational study of Acute Lymphoblastic Leukemia, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- 6-Mercaptopurine
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients ages 4-17 years of age who are receiving maintenance chemotherapy treatment for ALL with 6-MP will be included
Who may be able to join
- Patients ages 4-17 years of age who are receiving maintenance chemotherapy treatment for ALL with 6-MP will be included.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Mercy Hospital
Kansas City, Missouri, 64108
About this study
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).
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- 6-Mercaptopurine
- Keywords
- ALL, acute lymphoblastic leukemia, 6-Mercaptopurine, Pediatric
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6-MercaptopurineDrug
Also called 6-MP
75 mg/m2/dose/day
| Study group | Role | What they receive |
|---|---|---|
| 4-17 years, receiving 6-MP | Not described Receives: Drug: 6-Mercaptopurine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 8 hours post administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2011 (estimated)
- Study startJul 2011
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Collaborators
- Midwest Cancer Alliance
- Responsible party
- Sponsor
- Investigators
- Kathleen A Neville, MD, MS, Principal investigator, The Children's Mercy Hospitals and Clinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01324336
- Sponsor's protocol ID
- 6-MP pharmacokinetic 1
- Status last verified
- Dec 2020
- First submitted
- 25 Mar 2011
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Pharmacokinetics of a Compounded 6-mercaptopurine Liquid Formulation Preparation and Tablets
- ClinicalTrials.gov ID
- NCT01324336
- Acronym / sponsor ID
- 6-MP pharmacokinetic 1
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- ALL, acute lymphoblastic leukemia, 6-Mercaptopurine, Pediatric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Collaborators
- Midwest Cancer Alliance
- Study start
- Jul 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 29 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 4-17 years, receiving 6-MP | – | Drug: 6-Mercaptopurine |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients ages 4-17 years of age who are receiving maintenance chemotherapy treatment for ALL with 6-MP will be included
Key inclusion criteria (1 listed)
- Patients ages 4-17 years of age who are receiving maintenance chemotherapy treatment for ALL with 6-MP will be included.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 6-MercaptopurineAlso: 6-MP75 mg/m2/dose/day | Drug | 4-17 years, receiving 6-MP |
Primary outcome
Pharmacokinetics of 6-MP
Time frame: 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen A Neville, MD, MS principal investigator
The Children's Mercy Hospitals and Clinics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Lymphoblastic Leukemia, run by Children's Mercy Hospital Kansas City at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics of 6-MP (time frame: 8 hours post administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2021.