RECRUITING

Improving White Blood Cell Collection From Healthy Donors

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Collection of Granulocytes by Apheresis of Healthy Donors Stimulated With Filgrastim (G-CSF) and Dexamethasone

Quick Facts

Study Start:2012-12-31
Study Completion:2032-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT01553214

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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:
  2. * Age greater than or equal to18 and less than or equal to 75 years
  3. * If hypertension is present, must be well-controlled on medications
  4. * If peptic ulcer disease has been diagnosed in the past, symptoms must be well-controlled on medications
  5. * 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.
  1. * Information obtained from health history screen that does not meet the allogeneic donor eligibility criteria of the AABB Standards or the FDA CFR.
  2. * Weight less than 50 kg (110 lbs)
  3. * History of coronary heart disease
  4. * Uncontrolled hypertension (systolic BP \>160, diastolic BP \>100)
  5. * History of hepatitis or injection drug use
  6. * Diabetes mellitus requiring insulin
  7. * Active, symptomatic peptic ulcer disease
  8. * History of iritis or episcleritis
  9. * Sickle cell disease (sickle trait is acceptable). Testing for hemoglobin S is not required.
  10. * Lithium therapy
  11. * Pregnancy or nursing (breast feeding)
  12. * Renal function eGFR \< 45 ml/min/1.73m(2)

Contacts and Locations

Study Contact

Tania Scinto
CONTACT
(301) 496-9702
ts297r@nih.gov
Kamille A West-Mitchell, M.D.
CONTACT
(301) 594-5357
kamille.west@nih.gov

Principal Investigator

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

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Institutes of Health Clinical Center (CC)

  • Kamille A West-Mitchell, M.D., PRINCIPAL_INVESTIGATOR, National Institutes of Health Clinical Center (CC)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2012-12-31
Study Completion Date2032-01-01

Study Record Updates

Study Start Date2012-12-31
Study Completion Date2032-01-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Allogeneic Granulocyte Donation