Improving White Blood Cell Collection From Healthy Donors
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|ClinicalTrials.gov Identifier: NCT01553214|
Recruitment Status : Recruiting
First Posted : March 14, 2012
Last Update Posted : January 10, 2023
- 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.
- To improve the amount and quality of granulocytes (white blood cells) collected by apheresis for donation.
- Healthy volunteers between 18 and 75 years of age.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Allogeneic Granulocyte Donation||Drug: Filgrastim Drug: Dexamethasone||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1000 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Collection of Granulocytes by Apheresis of Healthy Donors Stimulated With Filgrastim (G-CSF) and Dexamethasone|
|Actual Study Start Date :||December 31, 2012|
|Estimated Primary Completion Date :||January 1, 2032|
|Estimated Study Completion Date :||January 1, 2032|
volunteer healthy donors willing to receive G-CSF and dexamethasone and undergo leukapheresis
Donors shall receive G-CSF 480 mcg as a single 1.6-mL subcutaneous injection 12 to 24 hours prior to donation.
Donors shall ingest dexamethasone 8 mg (two 4-mg tablets) orally 12 hours prior to donation.
- Operational feasibility and impact of managing a volunteer community donor granulocytapheresis program [ Time Frame: Annually ]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.
- Long-term adverse effects of repeated doses of filgrastim and dexamethasone in volunteer apheresis donors [ Time Frame: Annually ]Changes in CBC or health histories over time in donors continuing in the program.
- Frequency and severity (symptom grade) of acute adverse effects due to a single dose of filgrastim and dexamethasone in volunteer donors [ Time Frame: Annually ]Frequency and severity of acute adverse events related to G-CSF and dexamethasone in granulocyte donors.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01553214
|Contact: Tania Scinto||(301) firstname.lastname@example.org|
|Contact: Kamille A West, M.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY dial 711 firstname.lastname@example.org|
|Principal Investigator:||Kamille A West, M.D.||National Institutes of Health Clinical Center (CC)|