Normal PBPC DonorsNCT00115128
Open-Label Trial of Peripheral Blood Progenitor Cell (PBPC) Mobilization by Filgrastim in Normal Donors
An observational study of Normal PBPC Donors, run by Amgen.
Trial summary
The purpose of this study is to clinically evaluate the spleen during PBPC mobilization by filgrastim in normal donors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Normal PBPC Donors
- What is being tested?
- filgrastim
- How many people
- 309 participants
- Where
- No sites listed yet
- Study dates
- Nov 2003to Sep 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Normal donors
Inclusion Criteria: - Eligible to be PBPC donor for allogeneic transplantation as determined by local institution Exclusion Criteria: - History of splenectomy - Previous PBPC mobilization attempts - Previous treatment with GCSF or GMCSF
About this study
The purpose of this study is to clinically evaluate the spleen during PBPC mobilization by filgrastim in normal donors.
- Conditions
- Normal PBPC Donors
- Being tested
- filgrastim
- Keywords
- normal PBPC donors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filgrastimDrug
Normal donors being treated with filgrastim for PBPC mobilization and collection
| Study group | Role | What they receive |
|---|---|---|
| Filgrastim | Normal donors being treated with filgrastim for PBPC mobilization and collection Receives: Drug: filgrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spleen fold change measured by ultrasound
Measured: Before, during, and through 1 week post-PBPC mobilization and collection
Secondary outcomes (1)
Spleen change associations with filgrastim dose and hematologic variables
Measured: Before, during, and through 1 week post-PBPC mobilization and collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2005 (estimated)
- Study startNov 2003
- Primary completionMay 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Normal PBPC DonorsStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 309 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00115128
- Sponsor's protocol ID
- 20020143
- Status last verified
- May 2013
- First submitted
- 21 Jun 2005
- Last updated
- 13 May 2013
- Results posted
- No
Publications
Stiff PJ, Bensinger W, Abidi MH, Gingrich R, Artz AS, Nademanee A, Hansen KS, Sobczak C, Cutler C, Bolwell B, Shore TB, Lazarus HM, Yeager AM, Lovelace W, Guo M, Dreiling L. Clinical and ultrasonic evaluation of spleen size during peripheral blood progenitor cell mobilization by filgrastim: results of an open-label trial in normal donors. Biol Blood Marrow Transplant. 2009 Jul;15(7):827-34. doi: 10.1016/j.bbmt.2009.03.015.
PubMed 19539214
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Trial of Peripheral Blood Progenitor Cell (PBPC) Mobilization by Filgrastim in Normal Donors
- ClinicalTrials.gov ID
- NCT00115128
- Acronym / sponsor ID
- 20020143
- Conditions
- Normal PBPC Donors
- Keywords
- normal PBPC donors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 309 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Nov 2003
- Primary completion
- May 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 22 Jun 2005 (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.
The purpose of this study is to clinically evaluate the spleen during PBPC mobilization by filgrastim in normal donors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Filgrastim | – | Drug: filgrastimNormal donors being treated with filgrastim for PBPC mobilization and collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Normal donors
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 |
|---|---|---|
| filgrastimNormal donors being treated with filgrastim for PBPC mobilization and collection | Drug | Filgrastim |
Primary outcome
Spleen fold change measured by ultrasound
Time frame: Before, during, and through 1 week post-PBPC mobilization and collection
1 secondary outcome
Spleen change associations with filgrastim dose and hematologic variables
Time frame: Before, during, and through 1 week post-PBPC mobilization and collection
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 13 May 2013.
- Results publication: PubMed 19539214Stiff PJ, Bensinger W, Abidi MH, Gingrich R, Artz AS, Nademanee A, Hansen KS, Sobczak C, Cutler C, Bolwell B, Shore TB, Lazarus HM, Yeager AM, Lovelace W, Guo M, Dreiling L. Clinical and ultrasonic evaluation of spleen size during peripheral blood progenitor cell mobilization by filgrastim: results of an open-label trial in normal donors. Biol Blood Marrow Transplant. 2009 Jul;15(7):827-34. doi: 10.1016/j.bbmt.2009.03.015.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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.
MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
An observational study of Normal PBPC Donors, run by Amgen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 13 May 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Spleen fold change measured by ultrasound (time frame: Before, during, and through 1 week post-PBPC mobilization and collection). 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 NCT00115128, which also lists 1 linked publication.
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 13 May 2013.