Improving White Blood Cell Collection From Healthy Donors

NCT01553214 | Recruiting Phase 4

• 2 other identifiers: 12009612-CC-0096
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Background: \- White blood cells called granulocytes help the body fight infection. People who have had chemotherapy or bone marrow transplants may have very low numbers of these cells. Transfusions of these cells can help improve the body's ability to fight infection. However, most of the cells are located in the bone marrow or spleen, and are hard to collect from healthy donors. Two drugs, filgrastim and dexamethasone, can help move the cells to the bloodstream to be collected by apheresis. Researchers want to study the best ways to collect these white blood cells. They also want to monitor the effects of the injections and donations on the volunteer donors. Objectives: \- To improve the amount and quality of granulocytes (white blood cells) collected by apheresis for donation. Eligibility: \- Healthy volunteers between 18 and 75 years of age. Design:

• Participants will be screened with a physical exam and medical history. Initial blood tests will be done to check for eligibility.
• Participants will donate granulocytes by apheresis a maximum of 12 times in 1 year. Donations will not usually be requested more often than every 4 weeks. Donors will be allowed to decline participation at any time.
• Participants will have one injection of filgrastim 12 to 24 hours before donation. They will also have two tablets of dexamethasone 12 hours before donation.
• White blood cells will be collected through apheresis. The apheresis will last about 2 hours.
• Participants will be eligible to donate until they reach their 76th birthday.

Conditions

Allogeneic Granulocyte Donation

Keywords

Neutrophils; Infection; Granulocytapheresis; Mobilization; Transfusion; Healthy Volunteer; HV

Outcome Measures

Primary Outcomes (1)

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

  Establishment of a donor registry sufficient to meet the granulocyte transfusion needs of all Clinical Center patients. This endpoint shall include(1) the number of donors recruited into the program (2) the retention rate of donors in the program, assessed by number of donations per year per donor, cumulative number of granulocyte donations per donor, and duration of participation in the program per donor (3) the number of requests for a course of granulocytes per year and the number and percent of these requests that could be met, including the percent of all requested transfusion days on which granulocytes were available (4) the impediments to meeting all requests for granulocyte components, with an analysis of whether these are due to lack of an adequate donor supply or lack of adequate staffing or apheresis capacity (5) characteristics of the patients who are supported by a course of granulocyte transfusions.

  Annually

Secondary Outcomes (2)

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

  Annually

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

  Annually

Study Arms (1)

Donors

OTHER

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

Drug: Filgrastim; Drug: Dexamethasone

Interventions

Filgrastim DRUG

Donors shall receive G-CSF 480 mcg as a single 1.6-mL subcutaneous injection 12 to 24 hours prior to donation.

Donors

Dexamethasone DRUG

Donors shall ingest dexamethasone 8 mg (two 4-mg tablets) orally 12 hours prior to donation.

Donors

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Donors shall meet all donor eligibility criteria for allogeneic blood donors, as defined in the most recent editions of the AABB Standards and FDA Code of Federal Regulations (21CFR640). In addition, donors shall meet the following restrictions:
• Age greater than or equal to18 and less than or equal to 75 years
• If hypertension is present, must be well-controlled on medications
• If peptic ulcer disease has been diagnosed in the past, symptoms must be well-controlled on medications
• If cataracts have been diagnosed in the past, records from subject s ophthalmologist must be obtained indicating type of cataract. If PSC was diagnosed in the past, subject may receive G-CSF but not dexamethasone. The only exception to this is a history of bilateral cataract extractions due to PSC.

You may not qualify if:

• Information obtained from health history screen that does not meet the allogeneic donor eligibility criteria of the AABB Standards or the FDA CFR.
• Weight less than 50 kg (110 lbs).
• History of coronary heart disease
• Uncontrolled hypertension (systolic BP \>160, diastolic BP \>100)
• Diabetes mellitus requiring insulin
• Active, symptomatic peptic ulcer disease
• History of iritis or episcleritis
• Sickle cell disease (sickle trait is acceptable). Testing for hemoglobin S is not required.
• Lithium therapy
• Pregnancy or nursing (breast feeding)
• Renal function eGFR \< 45 ml/min/1.73m(2)

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Publications (3)

• Wingard JR, Carter SL, Walsh TJ, Kurtzberg J, Small TN, Baden LR, Gersten ID, Mendizabal AM, Leather HL, Confer DL, Maziarz RT, Stadtmauer EA, Bolanos-Meade J, Brown J, Dipersio JF, Boeckh M, Marr KA; Blood and Marrow Transplant Clinical Trials Network. Randomized, double-blind trial of fluconazole versus voriconazole for prevention of invasive fungal infection after allogeneic hematopoietic cell transplantation. Blood. 2010 Dec 9;116(24):5111-8. doi: 10.1182/blood-2010-02-268151. Epub 2010 Sep 8.

  PMID: 20826719 BACKGROUND

• Baddley JW, Andes DR, Marr KA, Kontoyiannis DP, Alexander BD, Kauffman CA, Oster RA, Anaissie EJ, Walsh TJ, Schuster MG, Wingard JR, Patterson TF, Ito JI, Williams OD, Chiller T, Pappas PG. Factors associated with mortality in transplant patients with invasive aspergillosis. Clin Infect Dis. 2010 Jun 15;50(12):1559-67. doi: 10.1086/652768.

  PMID: 20450350 BACKGROUND

• Stroncek DF, Yau YY, Oblitas J, Leitman SF. Administration of G--CSF plus dexamethasone produces greater granulocyte concentrate yields while causing no more donor toxicity than G--CSF alone. Transfusion. 2001 Aug;41(8):1037-44. doi: 10.1046/j.1537-2995.2001.41081037.x.

  PMID: 11493736 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Infections

Interventions

Filgrastim; Dexamethasone

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Leonard N Chen, M.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tania M Scinto

CONTACT

(301) 496-9702; ts297r@nih.gov

Leonard N Chen, M.D.

CONTACT

(301) 435-7969; leonard.chen@nih.gov

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2012
• First Posted: March 14, 2012
• Study Start: December 31, 2012
• Primary Completion (Estimated): January 1, 2032
• Study Completion (Estimated): January 1, 2032
• Last Updated: June 8, 2026

Record last verified: 2026-03-06

Locations

US (1)