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Filgrastim + Dexamethasone for Granulocyte Donation

Phase 4

Recruiting

Led By Kamille A West-Mitchell, M.D.

Research Sponsored by National Institutes of Health Clinical Center (CC)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age greater than or equal to 18 and less than or equal to 75 years

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up annually

Awards & highlights

Study Summary

This trial is testing a new way to collect white blood cells from donors to help people with low numbers of these cells.

Who is the study for?

Healthy volunteers aged 18-75 can join this trial to improve white blood cell collection for donations. They must meet standard donor criteria, have well-controlled hypertension or peptic ulcer disease if present, and not be underweight or have a history of severe heart disease, uncontrolled high blood pressure, hepatitis, drug use, insulin-requiring diabetes, active ulcers, certain eye conditions (iritis/episcleritis), sickle cell disease (trait is okay), lithium therapy, pregnancy/nursing or poor kidney function.Check my eligibility

What is being tested?

The trial tests the effectiveness of filgrastim and dexamethasone in increasing the amount and quality of granulocytes collected from donors through apheresis. Participants will receive an injection of filgrastim and two tablets of dexamethasone before undergoing a roughly 2-hour apheresis procedure up to 12 times per year.See study design

What are the potential side effects?

Potential side effects include bone pain or mild discomfort due to filgrastim injections and possible increased appetite, mood changes or stomach irritation from dexamethasone tablets. The actual experience may vary among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 75 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ annually

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~annually

This trial's timeline: 3 weeks for screening, Varies for treatment, and annually for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Operational feasibility and impact of managing a volunteer community donor granulocytapheresis program

Secondary outcome measures

Frequency and severity (symptom grade) of acute adverse effects due to a single dose of filgrastim and dexamethasone in volunteer donors

Long-term adverse effects of repeated doses of filgrastim and dexamethasone in volunteer apheresis donors

Trial Design

1Treatment groups

Experimental Treatment

Group I: DonorsExperimental Treatment2 Interventions

volunteer healthy donors willing to receive G-CSF and dexamethasone and undergo leukapheresis

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Filgrastim

2000

Completed Phase 3

~3670

Dexamethasone

2007

Completed Phase 4

~2590

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institutes of Health Clinical Center (CC)Lead Sponsor

383 Previous Clinical Trials

880,002 Total Patients Enrolled

Kamille A West-Mitchell, M.D.Principal InvestigatorNational Institutes of Health Clinical Center (CC)

3 Previous Clinical Trials

5,872 Total Patients Enrolled

Kamille A West, M.D.Principal InvestigatorNational Institutes of Health Clinical Center (CC)

3 Previous Clinical Trials

5,872 Total Patients Enrolled

Media Library

Donors Clinical Trial Eligibility Overview. Trial Name: NCT01553214 — Phase 4

Granulocyte Donation Research Study Groups: Donors

Granulocyte Donation Clinical Trial 2023: Donors Highlights & Side Effects. Trial Name: NCT01553214 — Phase 4

Donors 2023 Treatment Timeline for Medical Study. Trial Name: NCT01553214 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the sample size of this clinical trial?

"Affirmative. According to clinicaltrials.gov, this medical investigation is currently selecting participants; with the posting date of December 31st 2012 and last update on November 19th 2022. This research requires 1000 individuals across two sites to participate."

Answered by AI

What primary maladies is this remedy most frequently employed to address?

"This therapeutic intervention has been shown to be efficacious at treating ophthalmia, sympathetic conditions, branch retinal vein occlusions and macular edema."

Answered by AI

Have there been any antecedent research projects exploring this treatment?

"As of the present moment, there are 700 trials running which explore this treatment. 175 of those active studies have advanced to Phase 3 clinical research. The bulk of the tests occur in Mishawaka, Indiana but they can be found throughout 22210 locations across America."

Answered by AI

Has this remedy been ratified by the FDA?

"The safety of this particular therapy has been thoroughly documented and validated, thus receiving a score of 3 on the scale. This is due to its Phase 4 trial status which confirms that it has already received regulatory approval."

Answered by AI

Are researchers still accepting applicants for this clinical trial?

"Yes, the available information on clinicaltrials.gov verifies that this research is actively recruiting participants. The trial was initially posted at the end of 2012 and modified in November 2022; it seeks to enroll 1,000 patients from two separate sites."

Answered by AI