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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
Must not have
Diabetes mellitus requiring insulin
Renal function eGFR < 45 ml/min/1.73m(2)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up annually
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Drug Has Already Been Approved

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.
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.
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
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I am between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have diabetes and need insulin.
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My kidney function is low, with an eGFR below 45.
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I have sickle cell disease or carry the sickle cell trait.
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I have a history of hepatitis or I have used injection drugs.
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I weigh less than 110 lbs.
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I have a history of heart disease.
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I am currently taking lithium.
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I currently have an active, painful stomach ulcer.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Operational feasibility and impact of managing a volunteer community donor granulocytapheresis program
Secondary study objectives
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

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
~3690
Dexamethasone
2007
Completed Phase 4
~2650

Find a Location

Who is running the clinical trial?

National Institutes of Health Clinical Center (CC)Lead Sponsor
389 Previous Clinical Trials
30,878,736 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
~368 spots leftby Jan 2032
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