HealthyPhase 1NCT00001842
G-CSF for Granulocyte Donation
A Phase 1 study testing Granulocyte colony-stimulating factor and Dexamethasone in people with Healthy, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
This study will examine the feasibility of giving cell growth stimulants to granulocyte donors the same day of donation rather than the day before. People who donate granulocytes (infection-fighting white blood cells) for transfusion to patients with severe white cell deficiencies are often given a steroid called… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Granulocyte colony-stimulating factor and Dexamethasone
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 1999to Jun 2002
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Male and female subjects.
Must be 18 years of age or older.
Subjects must pass the health criteria for blood donors established by the American Association of Blood Banks.
No subjects who are pregnant or lactating females.
No subjects with uncontrolled hypertension, heart disease, diabetes, history of allergic reactions to G-CSF, history of allergic reactions to E. coli, abnormal hemoglobin or white blood cell counts, a malignancy, asthma, taking prednisone or using an inhalant.
No hemoglobin less than 11.0 or greater than 19.0 gm/dL
No platelet counts less than 140 x 10(9)/L or greater than 500 x 10(9)/L.
No absolute neutrophil count less than 1.5 x 10(9/)/L or greater than 10.0 x 10(9)/L.
Trial locations and contacts
1 site in 1 country.
United States1 site
Warren G. Magnuson Clinical Center (CC)
Bethesda, Maryland, 20892
About this study
Official title: Kinetics of Intravenous G-CSF-Induced Granulocyte Mobilization in Healthy Apheresis Donors
This study will examine the feasibility of giving cell growth stimulants to granulocyte donors the same day of donation rather than the day before.
People who donate granulocytes (infection-fighting white blood cells) for transfusion to patients with severe white cell deficiencies are often given a steroid called dexamethasone and a growth factor called G-CSF the day before donation. These drugs stimulate white cell production, allowing many more cells to be collected than would otherwise be possible. A single dose of G-CSF given to healthy people increases their white cells counts by four to five times the next day.
Read more
It would be preferable, however, to give G-CSF the same day of donation, if possible. Therefore, this study will measure white cell counts in healthy people at various intervals after being injected with G-CSF alone and G-CSF with dexamethasone. The study will compare the following: granulocyte counts at seven different intervals after injection of the drug or drugs; the effects of G-CSF injected through a vein or under the skin; and the effects of giving G-CSF alone or with dexamethasone.
Each participant will undergo four procedures, each four weeks apart as follows: donate a small blood sample; receive an injection of G-CSF under the skin or into a vein; and take either two dexamethasone tablets or two placebo tablets.
Small blood samples will then be drawn 1, 2, 4, 6, 8, and 24 hours after the drugs are given. Participants will answer questions about how they feel before the drugs are given and at the various intervals after taking the drugs.
Read the detailed description
The administration of granulocyte colony-stimulating factor (G-CSF) to increase the white blood cell count in granulocyte donors prior to donation is becoming an increasingly common practice. G-CSF is given subcutaneously to the donor on the day prior to donation, generally 12 to 24 hours before the start of apheresis. It would be advantageous to be able to give G-CSF and collect granulocytes on the same day. However, the single most important factor in optimizing granulocyte collection is the donor's pre-collection granulocyte count. Therefore, any decrease in count would result in a less cellular component. The purpose of this study is to assess granulocyte counts in healthy subjects during an 8-hour period after a single 5 microgram/kg intravenous dose of G-CSF with or without dexamethasone. Sixteen subjects will be studied. Each donor will be studied four separate times. The four mobilization protocols to be studied are G-CSF 5 micrograms/kg given intravenously, G-CSF 5 micrograms/kg subcutaneously, G-CSF 5 micrograms/kg intravenously plus dexamethasone 8 mg orally, and G-CSF 5 micrograms/kg subcutaneously plus dexamethasone 8 mg orally. The order of the route of administration will be assigned randomly. White blood cell counts, neutrophil counts and donor symptoms will be measured before G-CSF administration and at 1/2, 1, 2, 4, 6, 8 and 24 hours after administration. The neutrophil counts measured within the first 8 hours after G-CSF will be compared with counts measured 24 hours after G-CSF.
- Conditions
- Healthy
- Being tested
- Granulocyte colony-stimulating factor, Dexamethasone
- Keywords
- Granulocytes, Granulocyte Colony Stimulating Factor, Granulocyte Transfusion Factor, Apheresis, Blood Donors, Healthy Volunteer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Granulocyte colony-stimulating factorDrug
DexamethasoneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startJul 1999
- Study completionJun 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Enrolment
- 16 participants
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001842
- Sponsor's protocol ID
- 990141
- Other IDs
- 99-CC-0141
- Status last verified
- Jun 2002
- First submitted
- 31 Jul 2007
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Strauss RG. Therapeutic granulocyte transfusions in 1993. Blood. 1993 Apr 1;81(7):1675-8. No abstract available.
PubMed 8117344Strauss RG. Clinical perspectives of granulocyte transfusions: efficacy to date. J Clin Apher. 1995;10(3):114-8. doi: 10.1002/jca.2920100303.
PubMed 8582891Vamvakas EC, Pineda AA. Determinants of the efficacy of prophylactic granulocyte transfusions: a meta-analysis. J Clin Apher. 1997;12(2):74-81. doi: 10.1002/(sici)1098-1101(1997)12:23.0.co;2-6.
PubMed 9263114
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinetics of Intravenous G-CSF-Induced Granulocyte Mobilization in Healthy Apheresis Donors
- ClinicalTrials.gov ID
- NCT00001842
- Acronym / sponsor ID
- 990141
- Conditions
- Healthy
- Keywords
- Granulocytes, Granulocyte Colony Stimulating Factor, Granulocyte Transfusion Factor, Apheresis, Blood Donors, Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- Jul 1999
- Study completion
- Jun 2002
- First posted
- 4 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine the feasibility of giving cell growth stimulants to granulocyte donors the same day of donation rather than the day before.
People who donate granulocytes (infection-fighting white blood cells) for transfusion to patients with severe white cell deficiencies are often given a steroid called dexamethasone and a growth factor called G-CSF the day before donation. These drugs stimulate white cell production, allowing many more cells to be collected than would otherwise be possible. A single dose of G-CSF given to healthy people increases their white cells counts by four to five times the next day.
It would be preferable, however, to give G-CSF the same day of donation, if possible. Therefore, this study will measure white cell counts in healthy people at various intervals after being injected with G-CSF alone and G-CSF with dexamethasone. The study will compare the following: granulocyte counts at seven different intervals after injection of the drug or drugs; the effects of G-CSF injected through a vein or under the skin; and the effects of giving G-CSF alone or with dexamethasone.
Each participant will undergo four procedures, each four weeks apart as follows: donate a small blood sample; receive an injection of G-CSF under the skin or into a vein; and take either two dexamethasone tablets or two placebo tablets.
Small blood samples will then be drawn 1, 2, 4, 6, 8, and 24 hours after the drugs are given. Participants will answer questions about how they feel before the drugs are given and at the various intervals after taking the drugs.
Detailed description
The administration of granulocyte colony-stimulating factor (G-CSF) to increase the white blood cell count in granulocyte donors prior to donation is becoming an increasingly common practice. G-CSF is given subcutaneously to the donor on the day prior to donation, generally 12 to 24 hours before the start of apheresis. It would be advantageous to be able to give G-CSF and collect granulocytes on the same day. However, the single most important factor in optimizing granulocyte collection is the donor's pre-collection granulocyte count. Therefore, any decrease in count would result in a less cellular component. The purpose of this study is to assess granulocyte counts in healthy subjects during an 8-hour period after a single 5 microgram/kg intravenous dose of G-CSF with or without dexamethasone. Sixteen subjects will be studied. Each donor will be studied four separate times. The four mobilization protocols to be studied are G-CSF 5 micrograms/kg given intravenously, G-CSF 5 micrograms/kg subcutaneously, G-CSF 5 micrograms/kg intravenously plus dexamethasone 8 mg orally, and G-CSF 5 micrograms/kg subcutaneously plus dexamethasone 8 mg orally. The order of the route of administration will be assigned randomly. White blood cell counts, neutrophil counts and donor symptoms will be measured before G-CSF administration and at 1/2, 1, 2, 4, 6, 8 and 24 hours after administration. The neutrophil counts measured within the first 8 hours after G-CSF will be compared with counts measured 24 hours after G-CSF.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Granulocyte colony-stimulating factor | Drug | – |
| Dexamethasone | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 8117344Strauss RG. Therapeutic granulocyte transfusions in 1993. Blood. 1993 Apr 1;81(7):1675-8. No abstract available.
- Background: PubMed 8582891Strauss RG. Clinical perspectives of granulocyte transfusions: efficacy to date. J Clin Apher. 1995;10(3):114-8. doi: 10.1002/jca.2920100303.
- Background: PubMed 9263114Vamvakas EC, Pineda AA. Determinants of the efficacy of prophylactic granulocyte transfusions: a meta-analysis. J Clin Apher. 1997;12(2):74-81. doi: 10.1002/(sici)1098-1101(1997)12:23.0.co;2-6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Granulocyte colony-stimulating factor and Dexamethasone in people with Healthy, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001842, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.