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NCT01553214 · ClinicalTrials.gov registry record · Phase 4
Improving White Blood Cell Collection From Healthy Donors
A Phase 4 study of Allogeneic Granulocyte Donation, sponsored by National Institutes of Health Clinical Center (CC).
- Recruiting
- Registry status
- Phase 4
- Development phase
- 1,000
- Enrollment target
- 1
- Study location
NCT01553214: Recruiting Phase 4 study of Allogeneic Granulocyte Donation, sponsored by National Institutes of Health Clinical Center (CC).
NCT01553214 is a Phase 4 study of Allogeneic Granulocyte Donation that is actively recruiting participants, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 1,000 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01553214, a Phase 4 study of Allogeneic Granulocyte Donation, is actively recruiting participants, sponsored by National Institutes of Health Clinical Center (CC).
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 1,000 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Dexamethasone
- DRUG Filgrastim
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2012-12-31 |
| Est. Completion | 2032-01-01 |
| Phase | Phase 4 |
What NCT01553214 shows while recruiting
NCT01553214 is an interventional study that assigns participants to a tested intervention. Its 1,000 participants enrollment target places it among the larger protocols in the corpus, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% higher).
The record links to 1 condition, with Allogeneic Granulocyte Donation appearing as the primary indexed condition, and to 2 interventions - of which Dexamethasone is the first listed.
NCT01553214 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01553214 about?
NCT01553214 is a clinical study titled "Improving White Blood Cell Collection From Healthy Donors". 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 ar...
What is the current status of trial NCT01553214?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 1,000 participants. The study started on 2012-12-31. Estimated completion is 2032-01-01.
What conditions does trial NCT01553214 study?
This clinical trial studies the following conditions: Allogeneic Granulocyte Donation.
What interventions are being tested in trial NCT01553214?
The interventions under investigation include: Dexamethasone (DRUG), Filgrastim (DRUG).
Who is sponsoring clinical trial NCT01553214?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01553214 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01553214's enrollment target sits among peer trials
1,000 66th of 2000 higher than 1,930 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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