Normal PhysiologyNCT02322151
Pharmacokinetics of Granulocyte Colony Stimulating Factor in the Breast Milk of Volunteer Peripheral Blood Stem Cell Donor
An observational study of Normal Physiology, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
Background: The drug filgrastim (rGCSF) increases the number of blood-forming cells in the bloodstream. These cells can be collected from donors bloodstreams and used for transplant. Studies have shown that rGCSF is present in the breast milk of nursing mothers who are taking it. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Normal Physiology
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2014to 14 Oct 2016
- Phase
- Observational
- 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 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women enrolled in NIH protocol 00-CC-0165 and currently breastfeeding.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Background:
- The drug filgrastim (rGCSF) increases the number of blood-forming cells in the bloodstream. These cells can be collected from donors bloodstreams and used for transplant. Studies have shown that rGCSF is present in the breast milk of nursing mothers who are taking it. Based on these studies, it is now recommended that a nursing mother should not breastfeed from the time she receives the first dose of the drug until 2 days after the final dose. Researchers want to study the amount of the drug and its effect on the cells present in donor blood and breast milk. They hope to better understand the effects of this drug on breast milk.
Read more
Objectives:
- To understand the effects of filgrastim on breast milk.
Eligibility:
- Women enrolled in NIH protocol 00-CC-0165 and currently breastfeeding.
Design:
- Participants will receive rGCSF daily for 5 days. They will have blood taken daily.
- Participants will get a freezer bag containing 10 sterile, labeled containers for breast milk collection.
- Participants will transfer some of the breast milk they pump into one of the containers. They will write the date and time the milk was collected on the container. They will freeze the samples. Any remaining milk should be disposed of.
- Participants will bring the samples to NIH on the day of their stem cell collection procedure.
- For days 1 and 2 after stem cell collection, participants will continue to collect and freeze breast milk samples and dispose of any remaining milk.
- For days 3 5 after stem cell collection, participants will collect and freeze samples. They can also resume normal breastfeeding.
- A research nurse will arrange to collect the samples.
Read the detailed description
Recombinant human granulocyte colony stimulating factor (rhGCSF) is routinely administered to volunteer peripheral blood stem cell (PBSC) donors in the National Marrow Donor Program (NMDP). Information about the excretion and pharmacokinetics of rhGCSF into human breast milk, however, is extremely limited. Two case reports exist, the first demonstrating only that subcutaneously administered rhGCSF is present in breast milk,1 and the second demonstrating that rhGCSF is not only present, but also remains in breast milk for two days after discontinuation of the medication.2 Based on the data from the latter case report, the NMDP suggests that donors abstain from breastfeeding during the administration of rhGCSF and for 48 hours after the last dose of rhGCSF is given. We intend to collect and test breast milk and peripheral blood from one volunteer NMDP donor during the course of her rhGCSF therapy and for 5 days thereafter, with the intention of better characterizing this rare and unique situation. Collected samples will be used for granulocyte colony stimulating factor (GCSF) quantitation and complete blood counts. Additionally, we will collect a single breast milk sample from three rhGCSF-na(SqrRoot) ve volunteers for use as negative control samples for assay calibration.
- Conditions
- Normal Physiology
- Keywords
- Filgrastim, Neupogen, Transplant, Breast Feeding, Concentration
- Medical subject headings
- Breast Feeding
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of collected samples
Measured: Within one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study start12 Dec 2014
- Primary completion9 Nov 2015
- Study completion14 Oct 2016
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 Normal PhysiologyStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Kathleen A Conry Cantilena, M.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02322151
- Sponsor's protocol ID
- 150047
- Other IDs
- 15-CC-0047
- Status last verified
- 14 Oct 2016
- First submitted
- 19 Dec 2014
- Last updated
- 16 Dec 2019
- Results posted
- No
Publications
Shibata H, Yamane T, Aoyama Y, Nakamae H, Hasegawa T, Sakamoto C, Terada Y, Koh G, Hino M. Excretion of granulocyte colony-stimulating factor into human breast milk. Acta Haematol. 2003;110(4):200-1. doi: 10.1159/000074226. No abstract available.
PubMed 14663166Kaida K, Ikegame K, Fujioka T, Taniguchi Y, Inoue T, Hasei H, Tamaki H, Yoshihara S, Kawase I, Ogawa H. Kinetics of granulocyte colony-stimulating factor in the human milk of a nursing donor receiving treatment for mobilization of the peripheral blood stem cells. Acta Haematol. 2007;118(3):176-7. doi: 10.1159/000109267. Epub 2007 Oct 3. No abstract available.
PubMed 17914246Pessach I, Shimoni A, Nagler A. Granulocyte-colony stimulating factor for hematopoietic stem cell donation from healthy female donors during pregnancy and lactation: what do we know? Hum Reprod Update. 2013 May-Jun;19(3):259-67. doi: 10.1093/humupd/dms053. Epub 2013 Jan 3.
PubMed 23287427
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Granulocyte Colony Stimulating Factor in the Breast Milk of Volunteer Peripheral Blood Stem Cell Donor
- ClinicalTrials.gov ID
- NCT02322151
- Acronym / sponsor ID
- 150047
- Conditions
- Normal Physiology
- Keywords
- Filgrastim, Neupogen, Transplant, Breast Feeding, Concentration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 12 Dec 2014
- Primary completion
- 9 Nov 2015 (actual)
- Study completion
- 14 Oct 2016 (actual)
- First posted
- 23 Dec 2014 (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.
Background:
- The drug filgrastim (rGCSF) increases the number of blood-forming cells in the bloodstream. These cells can be collected from donors bloodstreams and used for transplant. Studies have shown that rGCSF is present in the breast milk of nursing mothers who are taking it. Based on these studies, it is now recommended that a nursing mother should not breastfeed from the time she receives the first dose of the drug until 2 days after the final dose. Researchers want to study the amount of the drug and its effect on the cells present in donor blood and breast milk. They hope to better understand the effects of this drug on breast milk.
Objectives:
- To understand the effects of filgrastim on breast milk.
Eligibility:
- Women enrolled in NIH protocol 00-CC-0165 and currently breastfeeding.
Design:
- Participants will receive rGCSF daily for 5 days. They will have blood taken daily.
- Participants will get a freezer bag containing 10 sterile, labeled containers for breast milk collection.
- Participants will transfer some of the breast milk they pump into one of the containers. They will write the date and time the milk was collected on the container. They will freeze the samples. Any remaining milk should be disposed of.
- Participants will bring the samples to NIH on the day of their stem cell collection procedure.
- For days 1 and 2 after stem cell collection, participants will continue to collect and freeze breast milk samples and dispose of any remaining milk.
- For days 3 5 after stem cell collection, participants will collect and freeze samples. They can also resume normal breastfeeding.
- A research nurse will arrange to collect the samples.
Detailed description
Recombinant human granulocyte colony stimulating factor (rhGCSF) is routinely administered to volunteer peripheral blood stem cell (PBSC) donors in the National Marrow Donor Program (NMDP). Information about the excretion and pharmacokinetics of rhGCSF into human breast milk, however, is extremely limited. Two case reports exist, the first demonstrating only that subcutaneously administered rhGCSF is present in breast milk,1 and the second demonstrating that rhGCSF is not only present, but also remains in breast milk for two days after discontinuation of the medication.2 Based on the data from the latter case report, the NMDP suggests that donors abstain from breastfeeding during the administration of rhGCSF and for 48 hours after the last dose of rhGCSF is given. We intend to collect and test breast milk and peripheral blood from one volunteer NMDP donor during the course of her rhGCSF therapy and for 5 days thereafter, with the intention of better characterizing this rare and unique situation. Collected samples will be used for granulocyte colony stimulating factor (GCSF) quantitation and complete blood counts. Additionally, we will collect a single breast milk sample from three rhGCSF-na(SqrRoot) ve volunteers for use as negative control samples for assay calibration.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women enrolled in NIH protocol 00-CC-0165 and currently breastfeeding.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Analysis of collected samples
Time frame: Within one year
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 16 Dec 2019.
- Background: PubMed 14663166Shibata H, Yamane T, Aoyama Y, Nakamae H, Hasegawa T, Sakamoto C, Terada Y, Koh G, Hino M. Excretion of granulocyte colony-stimulating factor into human breast milk. Acta Haematol. 2003;110(4):200-1. doi: 10.1159/000074226. No abstract available.
- Background: PubMed 17914246Kaida K, Ikegame K, Fujioka T, Taniguchi Y, Inoue T, Hasei H, Tamaki H, Yoshihara S, Kawase I, Ogawa H. Kinetics of granulocyte colony-stimulating factor in the human milk of a nursing donor receiving treatment for mobilization of the peripheral blood stem cells. Acta Haematol. 2007;118(3):176-7. doi: 10.1159/000109267. Epub 2007 Oct 3. No abstract available.
- Background: PubMed 23287427Pessach I, Shimoni A, Nagler A. Granulocyte-colony stimulating factor for hematopoietic stem cell donation from healthy female donors during pregnancy and lactation: what do we know? Hum Reprod Update. 2013 May-Jun;19(3):259-67. doi: 10.1093/humupd/dms053. Epub 2013 Jan 3.
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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.
Kathleen A Conry Cantilena, M.D. principal investigator
National Institutes of Health Clinical Center (CC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Normal Physiology, 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.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2019. 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.
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.
What does the primary outcome measure?
Analysis of collected samples (time frame: Within one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02322151, 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 16 Dec 2019.