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
: March 29, 2018
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Blood Donor Leukocyte Transfusion Granulocyte Colony-Stimulation Factor Blood Component Removal | Drug: Filgrastim (G-CSF) Drug: Dexamethasone | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 1000 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | Collection of Granulocytes by Apheresis of Healthy Donors Stimulated With Filgrastim (G-CSF) and Dexamethasone |
Study Start Date : | March 7, 2012 |
Estimated Primary Completion Date : | January 1, 2030 |
Estimated Study Completion Date : | January 1, 2030 |

Arm | Intervention/treatment |
---|---|
1
There are no arms in this study
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Drug: Filgrastim (G-CSF)
Recombinant G-CSF is available from the Clinical Center pharmacy in colorless glass, single-use vials containing 480 mcg G-CSF in 1.6 mL vials (300 mcg/mL). It is formulated as a sterile, clear, colorless liquid in 10 mm sodium acetate buffer at pH 4.0. The quantitative composition (per mL) is: Recombinant human G-CSF 300 mcg Acetate 0.59 mg Mannitol 50 mg Tween 80TM 0.004% Sodium 0.035 mg Water for injection (qs ad) to 1.0 mL Storage: The intact vials of G-CSF should be stored under refrigeration (2-8 degrees Celsius). Administration: G-CSF is administered subcutaneously, with the entire contents of one 1.6 mL vial given in one injection 12 to 24 hours prior to apheresis.Stability: G-CSF in the intact vial is stable for 36 months when stored in a refrigerator at 2-8 degrees Celsius. A single brief exposure (up to 7 days) to elevated temperatures (<37 degrees Celsius) does not affect the stability. G-CSF should not be frozen, and vials that have been frozen should not be used.
Drug: Dexamethasone
Oral dexamethasone is available from the Clinical Center pharmacy as green 4 mg tablets. The tablets contain the following inactive ingredients: lactose monohydrate, magnesium stearate, starch, sucrose, FD&C Green No. 3, FD&C Yellow No. 10, and FD&C Yellow No. 6. They are packaged in unit-dose blister pack strips. Storage: Dexamethasone tablets should be stored at room temperature (20-25 degrees Celsius). Administration: Dexamethasone is administered as two 4-mg tablets 12 hours prior to apheresis (approximately one hour after dinner the evening prior to apheresis). Stability: Dexamethasone is stable for 36 months when stored at room temperature in an unopened blister pack.
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2
There are no arms in this study
|
Drug: Filgrastim (G-CSF)
Recombinant G-CSF is available from the Clinical Center pharmacy in colorless glass, single-use vials containing 480 mcg G-CSF in 1.6 mL vials (300 mcg/mL). It is formulated as a sterile, clear, colorless liquid in 10 mm sodium acetate buffer at pH 4.0. The quantitative composition (per mL) is: Recombinant human G-CSF 300 mcg Acetate 0.59 mg Mannitol 50 mg Tween 80TM 0.004% Sodium 0.035 mg Water for injection (qs ad) to 1.0 mL Storage: The intact vials of G-CSF should be stored under refrigeration (2-8 degrees Celsius). Administration: G-CSF is administered subcutaneously, with the entire contents of one 1.6 mL vial given in one injection 12 to 24 hours prior to apheresis.Stability: G-CSF in the intact vial is stable for 36 months when stored in a refrigerator at 2-8 degrees Celsius. A single brief exposure (up to 7 days) to elevated temperatures (<37 degrees Celsius) does not affect the stability. G-CSF should not be frozen, and vials that have been frozen should not be used.
Drug: Dexamethasone
Oral dexamethasone is available from the Clinical Center pharmacy as green 4 mg tablets. The tablets contain the following inactive ingredients: lactose monohydrate, magnesium stearate, starch, sucrose, FD&C Green No. 3, FD&C Yellow No. 10, and FD&C Yellow No. 6. They are packaged in unit-dose blister pack strips. Storage: Dexamethasone tablets should be stored at room temperature (20-25 degrees Celsius). Administration: Dexamethasone is administered as two 4-mg tablets 12 hours prior to apheresis (approximately one hour after dinner the evening prior to apheresis). Stability: Dexamethasone is stable for 36 months when stored at room temperature in an unopened blister pack.
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3
There are no arms in this study
|
Drug: Filgrastim (G-CSF)
Recombinant G-CSF is available from the Clinical Center pharmacy in colorless glass, single-use vials containing 480 mcg G-CSF in 1.6 mL vials (300 mcg/mL). It is formulated as a sterile, clear, colorless liquid in 10 mm sodium acetate buffer at pH 4.0. The quantitative composition (per mL) is: Recombinant human G-CSF 300 mcg Acetate 0.59 mg Mannitol 50 mg Tween 80TM 0.004% Sodium 0.035 mg Water for injection (qs ad) to 1.0 mL Storage: The intact vials of G-CSF should be stored under refrigeration (2-8 degrees Celsius). Administration: G-CSF is administered subcutaneously, with the entire contents of one 1.6 mL vial given in one injection 12 to 24 hours prior to apheresis.Stability: G-CSF in the intact vial is stable for 36 months when stored in a refrigerator at 2-8 degrees Celsius. A single brief exposure (up to 7 days) to elevated temperatures (<37 degrees Celsius) does not affect the stability. G-CSF should not be frozen, and vials that have been frozen should not be used.
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4
There are no arms in this study
|
Drug: Filgrastim (G-CSF)
Recombinant G-CSF is available from the Clinical Center pharmacy in colorless glass, single-use vials containing 480 mcg G-CSF in 1.6 mL vials (300 mcg/mL). It is formulated as a sterile, clear, colorless liquid in 10 mm sodium acetate buffer at pH 4.0. The quantitative composition (per mL) is: Recombinant human G-CSF 300 mcg Acetate 0.59 mg Mannitol 50 mg Tween 80TM 0.004% Sodium 0.035 mg Water for injection (qs ad) to 1.0 mL Storage: The intact vials of G-CSF should be stored under refrigeration (2-8 degrees Celsius). Administration: G-CSF is administered subcutaneously, with the entire contents of one 1.6 mL vial given in one injection 12 to 24 hours prior to apheresis.Stability: G-CSF in the intact vial is stable for 36 months when stored in a refrigerator at 2-8 degrees Celsius. A single brief exposure (up to 7 days) to elevated temperatures (<37 degrees Celsius) does not affect the stability. G-CSF should not be frozen, and vials that have been frozen should not be used.
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- To determine the operational feasibility and impact of managing a volunteer community donor granulocytapheresis program [ Time Frame: Annually. The feasibility of continuing the granulocyte donation program will be assessed, based on resource need and allocation, operational impact, adverse effects in donors, and survival outcomes of recipients. ]
- To monitor the frequency and severity (symptom grade) of acute adverse effects due to a single dose of filgrastim and dexamethasone in volunteer donors [ Time Frame: 48 hours after last GCSF dose. The feasibility of continuing the granulocyte donation program will be assessed, based on resource need and allocation, operational impact, adverse effects in donors, and survival outcomes of recipients. ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
- INCLUSION CRITERIA:
- 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.
EXCLUSION CRITERIA:
- 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)
- History of hepatitis or injection drug use
- 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)

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: Yu Ying Yau, R.N. | (301) 435-3049 | yyau@mail.cc.nih.gov | |
Contact: Kathleen A Cantilena, M.D. | (301) 451-8637 | ccantilena@mail.nih.gov |
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | 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 TTY8664111010 prpl@cc.nih.gov |
Principal Investigator: | Kathleen A Cantilena, M.D. | National Institutes of Health Clinical Center (CC) |
Additional Information:
Publications:
ClinicalTrials.gov Identifier: | NCT01553214 History of Changes |
Other Study ID Numbers: |
120096 12-CC-0096 |
First Posted: | March 14, 2012 Key Record Dates |
Last Update Posted: | March 29, 2018 |
Last Verified: | March 27, 2018 |
Keywords provided by National Institutes of Health Clinical Center (CC):
Healthy Volunteers Granulocyte Transfusion Granulocytapheresis Leukapheresis |
Cytokine Stimulation Healthy Volunteer HV |
Additional relevant MeSH terms:
Dexamethasone acetate Dexamethasone BB 1101 Lenograstim Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents |
Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Adjuvants, Immunologic Immunologic Factors |