Hematological MalignancyNCT01719432
Effect of Body Mass on Filgrastim Pharmacokinetics
An observational study of Hematological Malignancy and Neutropenia, run by Aaron Cumpston, PharmD, BCOP at 1 site in United States.
Trial summary
Studies have shown that different percentages of body fat can alter the way drugs are distributed in the body. This study will use blood samples taken at different time points for patients taking Neupogen to determine if higher body weights affect drug exposure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematological Malignancy, Neutropenia
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2012to Dec 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Obese and non-obese patients receiving filgrastim
Who may be able to join
- Age greater than or equal to 18 years
- Receiving filgrastim at 5mcg/kg ± 10%
- Admitted as an inpatient with an expected stay of at least 24 hours
- Weight is > 190% of their ideal body weight (IBW) for "obese" patients or within 80 - 124% of IBW for matched control patients.
- Patient or their legally authorized representative understands and voluntarily signs the written informed consent prior to any study-specific procedures. A copy of the signed informed consent form will be retained by the treating institution.
Who cannot join
- Patients who have received filgrastim within 24 hours prior to enrollment
- Patients who have received pegfilgrastim within 14 days prior to enrollment
- Hypersensitivity reaction to filgrastim or any related product
- Patients who have taken lithium within 7 days of enrollment
- Serum Creatinine > 1.5 mg/dL
- Patients who are pregnant or breastfeeding
- Patients who are unable to understand and/or render informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
West Virginia University Mary Babb Randolph Cancer Center
Morgantown, West Virginia, 26506
About this study
Studies have shown that different percentages of body fat can alter the way drugs are distributed in the body. This study will use blood samples taken at different time points for patients taking Neupogen to determine if higher body weights affect drug exposure. The information gathered from this study will help understand if patients with higher body weights need a different dosing plan.
Patients in this study will have blood draws once before they take Neupogen and 6 times after they take the Neuopen (for a total of 24 hours). These patients will be in the hospital already and will not need to make additional trips back to have blood drawn. A total of about 5-6 tablespoons of blood will be drawn for this study. 15 obese patients and 15 matched, non-obese patients will be enrolled into this study.
- Conditions
- Hematological Malignancy, Neutropenia
- Keywords
- Filgrastim, Obese, Non-obese, Pharmacokinetics
- Medical subject headings
- Hematologic Neoplasms, Neutropenia, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Obese patients | Not described | |
| Non-obese patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systemic clearance of filgrastim in obese and non-obese patients
Measured: 24 hours
Secondary outcomes (4)
Alpha and beta half-life of filgrastim in obese and non-obese patients
Measured: 24 hours
Maximum concentration (Cmax) of filgrastim in obese and non-obese patients
Measured: 24 hours
Time to maximum concentration (Tmax) of filgrastim in obese and non-obese patients
Measured: 24 hours
Volume of distribution (Vds and Vdss)of filgrastim in obese and non-obese patients
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2012 (estimated)
- Study start5 Dec 2012
- Primary completionDec 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hematological MalignancyStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aaron Cumpston, PharmD, BCOP
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aaron Cumpston, PharmD, BCOP, West Virginia University
- Investigators
- Aaron Cumpston, PharmD, BCOP, Principal investigator, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01719432
- Sponsor's protocol ID
- WVU 021112
- Status last verified
- Dec 2020
- First submitted
- 29 Oct 2012
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Stewart AW, Shillingburg A, Petros W, Wen S, Piktel D, Moses R, Gibson LF, Craig M, Cumpston A. A prospective study of filgrastim pharmacokinetics in morbidly obese patients compared with non-obese controls. Pharmacotherapy. 2022 Jan;42(1):53-57. doi: 10.1002/phar.2646. Epub 2021 Nov 22.
PubMed 34767652
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Body Mass on Filgrastim Pharmacokinetics
- ClinicalTrials.gov ID
- NCT01719432
- Acronym / sponsor ID
- WVU 021112
- Conditions
- Hematological Malignancy, Neutropenia
- Keywords
- Filgrastim, Obese, Non-obese, Pharmacokinetics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Aaron Cumpston, PharmD, BCOPUniversity, hospital or other
- Study start
- 5 Dec 2012 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 1 Nov 2012 (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.
Studies have shown that different percentages of body fat can alter the way drugs are distributed in the body. This study will use blood samples taken at different time points for patients taking Neupogen to determine if higher body weights affect drug exposure. The information gathered from this study will help understand if patients with higher body weights need a different dosing plan.
Patients in this study will have blood draws once before they take Neupogen and 6 times after they take the Neuopen (for a total of 24 hours). These patients will be in the hospital already and will not need to make additional trips back to have blood drawn. A total of about 5-6 tablespoons of blood will be drawn for this study. 15 obese patients and 15 matched, non-obese patients will be enrolled into this study.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese patients | – | – |
| Non-obese patients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Obese and non-obese patients receiving filgrastim
Key inclusion criteria (5 listed)
- Age greater than or equal to 18 years
- Receiving filgrastim at 5mcg/kg ± 10%
- Admitted as an inpatient with an expected stay of at least 24 hours
- Weight is > 190% of their ideal body weight (IBW) for "obese" patients or within 80 - 124% of IBW for matched control patients.
- Patient or their legally authorized representative understands and voluntarily signs the written informed consent prior to any study-specific procedures. A copy of the signed informed consent form will be retained by the treating institution.
Key exclusion criteria (7 listed)
- Patients who have received filgrastim within 24 hours prior to enrollment
- Patients who have received pegfilgrastim within 14 days prior to enrollment
- Hypersensitivity reaction to filgrastim or any related product
- Patients who have taken lithium within 7 days of enrollment
- Serum Creatinine > 1.5 mg/dL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Systemic clearance of filgrastim in obese and non-obese patients
Time frame: 24 hours
4 secondary outcomes
Alpha and beta half-life of filgrastim in obese and non-obese patients
Time frame: 24 hours
Maximum concentration (Cmax) of filgrastim in obese and non-obese patients
Time frame: 24 hours
Time to maximum concentration (Tmax) of filgrastim in obese and non-obese patients
Time frame: 24 hours
Volume of distribution (Vds and Vdss)of filgrastim in obese and non-obese patients
Time frame: 24 hours
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 17 Dec 2020.
- Derived from this study: PubMed 34767652Stewart AW, Shillingburg A, Petros W, Wen S, Piktel D, Moses R, Gibson LF, Craig M, Cumpston A. A prospective study of filgrastim pharmacokinetics in morbidly obese patients compared with non-obese controls. Pharmacotherapy. 2022 Jan;42(1):53-57. doi: 10.1002/phar.2646. Epub 2021 Nov 22.
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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.
Aaron Cumpston, PharmD, BCOP principal investigator
West Virginia University
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 Hematological Malignancy and Neutropenia, run by Aaron Cumpston, PharmD, BCOP 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 5 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 17 Dec 2020. 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?
Systemic clearance of filgrastim in obese and non-obese patients (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01719432, which also lists 1 linked publication.
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 17 Dec 2020.