HealthyPhase 2NCT00082329
G-CSF and AMD3100 to Mobilize Stem Cells in Healthy Volunteers
A Phase 2 study testing AMD 3100 (Mozobil plerixafor) and Granulocyte colony-stimulating factor (G-CSF) in people with Healthy, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial summary
This 12-day study will test whether the combination of G-CSF (granulocyte-colony stimulating factor) and AMD3100 (Mozobil) is more efficient in mobilizing stem cells for collection than the use of G-CSF alone. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- AMD 3100 (Mozobil plerixafor) and Granulocyte colony-stimulating factor (G-CSF)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2004to 25 Oct 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers greater or equal to 18 years old, less than or equal to 60 years.
- Weight greater than 60 kg (132 pounds)
- Normal renal function: creatinine less than 1.5 mg/dl l
- Normal liver function: bilirubin less than1.5mg/dl, transaminases within normal limit
- Normal blood count: white blood cell (WBC) 3000-10000/mm3, granulocytes greater than 1500/mm3, platelets greater than 150,000/mm3, hemoglobin greater than 12.5g/dl
- Subject must be eligible for normal blood donation and fit to undergo apheresis procedure (antecubital veins must be adequate for peripheral access during apheresis)
- Ability to comprehend the investigational nature of the study and provide informed consent
Who cannot join
- Active infection or history of recurrent infection or positive test for syphilis (RPR), hepatitis B and C (HBaSAg, Anti-HCV), HIV and human T- Lymphocytic virus (HTLV-1)
- History of autoimmune disease such as rheumatoid arthritis, systemic lupus erythematous
- History of cancer within the past 5 years excluding basal cell or squamous cell carcinoma of the skin
- History of any hematologic disorders including thromboembolic disease
- History of cardiac disease such as uncontrolled hypertension, peripheral vascular disease, myocardial infarction, cardiac arrhythmias or related symptoms such as tachycardia, chest pain, shortness of breath which have required medical intervention or treatment or a Framingham coronary disease risk prediction score of greater than 10% 10 year coronary heart disease (CHD) risk
- History of heavy smoking with underlying pulmonary disease
Show all 11Show fewer
- History of cerebrovascular disease, transient ischemic attack, or stroke
- Diagnosis of sickle cell anemia or sickle cell trait (to be screened by hemoglobin (Hbg) electrophoresis)
- Pregnant or lactating
- Severe psychiatric illness: mental deficiency sufficiently severe as to make informed consent impossible.
- Mobilization with G-CSF within 90 days of protocol enrollment.
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
Official title: Peripheral Blood Hematopoietic Progenitor Cell Mobilization Using Granulocyte Colony Stimulating Factor (G-CSF) Combined With AMD3100 Mozobil (Plerixafor) in Healthy Volunteers
This 12-day study will test whether the combination of G-CSF (granulocyte-colony stimulating factor) and AMD3100 (Mozobil) is more efficient in mobilizing stem cells for collection than the use of G-CSF alone. Traditionally, the growth factor G-CSF has been given to stem cell donors to mobilize, or push, stem cells out of the bone marrow and into the blood circulation for collection for transplantation. Although a sufficient quantity of cells usually can be collected with G-CSF treatment, some donors do not respond well and may require multiple apheresis procedures (see below) to collect enough cells. Studies indicate that G-CSF used together with a drug called AMD3100 may be more effective in mobilizing stem cells for collection than G-CSF alone. The Food and Drug Administration has approved G-CSF for stem cell mobilization. AMD3100 is a new drug that also mobilizes stem cells in large numbers within a few hours.
Normal healthy volunteers between 18 and 60 years of age may be eligible for this study.
Read the detailed description
Peripheral blood progenitor cells (PBPC) are the most popular source of hematopoetic stem cells for allogeneic transplantation because of technical ease of collection and faster engraftment. Traditionally, granulocyte-colony stimulating factor (G-CSF) has been used to procure the peripheral blood stem cell graft. Although regimens using G-CSF usually succeed in collecting adequate numbers of PBPC from healthy donors, 5%-10% of the donors will mobilize stem cells poorly and may require multiple large volume apheresis or bone marrow harvesting. AMD3100 reversibly inhibits CXC- chemokine receptor 4 (CXCR4) binding to stromal cell derived factor (SDF) - 1 and was recently discovered to be an effective agent to mobilize cluster of differentiation 34 (CD34)+ cells into the peripheral blood. In normal volunteers, administering AMD3100 after 4-5 days of G-CSF resulted in a 3-3.5 fold increase in circulating CD34 cells compared to G-CSF alone. Recent data has suggested that the combination of G-CSF and AMD3100 is superior to G-CSF alone for mobilizing hematopoietic progenitor cells in heavily pretreated patients with multiple myeloma or non-Hodgkin's lymphoma undergoing autologous hematopoietic transplantation. Combining AMD3100 with G-CSF could be an effective strategy to improve the yield of PBPC collected from allogeneic donors who mobilize poorly with G-CSF alone. However, the biological impact of AMD3100 in this context on T cells and other cellular populations contained within the allograft that mediate graft versus host disease (GVHD) and graft-versus-leukemia (GVL) effects are unknown.
We propose to collect peripheral progenitor cell (PBPC) from healthy volunteers following 5 days of G-CSF (10 mcg/kg/day) and a single dose of AMD3100 (240 mcg/kg subcutaneous given 12 hours before starting apheresis) to study the impact of combining these two mobilizing agents on the immunological properties of the mobilized cells. A single 15 liter apheresis will be conducted on day 5 following the 5th dose of G-CSF. The immunological studies conducted on these mobilized cells will be the same as our parallel study which is investigating the immune properties of PBPCs mobilized with G-CSF or AMD3100 alone. If combining AMD3100 with G-CSF has no negative impact on the immune populations involved in GVHD and graft-vs-leukemia effects, this regimen could be used for allogeneic donors who fail to mobilize sufficient peripheral blood stem cell (PBSC) using G-CSF alone.
Primary objective: To determine the cytokine polarization status of cluster of differentiation 4 (CD4+) T-cells collected by apheresis following combination of AMD3100 and G-CSF compared to G-CSF mobilization.
Primary endpoint: the ratio of Th1 [intracellular interferon (IFN-g) +] versus Th2 [intracellular interleukin (IL-4+)] T-cells in the apheresis products collected from individual donors undergoing mobilization with combination of G-CSF and AMD3100 to the ratio in apheresis product collected with G-CSF alone (ratio published in literature).
Secondary endpoints: To examine 1) the cellular content and other immune properties of mobilized cells; 2) yields of hematopoietic progenitor cells, immune cells, and other cellular subsets collected by apheresis; and the 3) safety profile of AMD3100.
- Conditions
- Healthy
- Being tested
- AMD 3100 (Mozobil plerixafor), Granulocyte colony-stimulating factor (G-CSF)
- Keywords
- Hematopoietic Stem Cells, PBSC's, Mobilization, Alloreactivity, T Cell Polarization, Dendritic Cells, CXCR4, Plerixafor, Healthy Volunteer (HV)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMD 3100 (Mozobil plerixafor)Drug
Also called AMD 3100
Participants received subcutaneous injection of granulocyte colony-stimulating factor (G-CSF) at 10 mcg/kg/day for 5 days followed by a single subcutaneous injection of AMD3100 (240 mcg/kg) given 12 hours prior to apheresis peripheral blood stem cell collection. Peripheral blood stem cell collection performed on the fifth day of G-CSF administration.
Granulocyte colony-stimulating factor (G-CSF)Drug
Also called G-CSF
Participants received subcutaneous injection of granulocyte colony-stimulating factor (G-CSF) at 10 mcg/kg/day for 5 days followed by a single subcutaneous injection of AMD3100 (240 mcg/kg) given 12 hours prior to apheresis peripheral blood stem cell collection. Peripheral blood stem cell collection performed on the fifth day of G-CSF administration.
| Study group | Role | What they receive |
|---|---|---|
| G-CSF and AMD3100 to Mobilize Stem Cells in Healthy Volunteers | Experimental | Participants received subcutaneous injection of G-CSF (10 mcg/kg/day) for 5 days followed by a single subcutaneous injection of AMD3100 (240 mcg/kg) given 12 hours prior to apheresis peripheral blood stem cell collection. Peripheral blood stem cell collection performed on the fifth day of G-CSF administration. Receives: Drug: AMD 3100 (Mozobil plerixafor); Drug: Granulocyte colony-stimulating factor (G-CSF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Successful Apheresis Collection Following Combination of AMD3100 and G-CSF.
Healthy volunteers will be administered AMD 3100 (Mozobil plerixafor) and granulocyte colony stimulating factor (G-CSF) to determine cytokine polarization status of cluster of differentiation (CD 4) T-cells collected by apheresis.
We propose that the combination of single dose AMD 3100 and G-CSF as combined mobilizing agents will improve the peripheral blood progenitor cells mobilization. Successful treatment responders is defined by completing study treatment with cell mobilization and cell collection. Non-responders is defined by having completed the study treatment and having cell mobilization without cell collection.
Measured: Day 1 (cells are counted 24 hours after AMD3100)
Secondary outcomes (2)
Average Fold Change From Baseline of Mobilized Cells Following G-CSF and AMD3100 to Mobilize Stem Cells in Healthy Volunteers
Average fold change from baseline of mobilized cells that contained immune properties and other cellular content following G-CSF and AMD3100 to mobilize stem cells in healthy volunteers. The mobilized cells are defined as: white blood cells, lymphocytes, polys and monocytes. Polys (also known as segs, segmented neutrophils, neutrophils, granulocytes) are the most numerous of our white blood cells.
Measured: Day 7
Number of Participants With Increased the Levels of Circulating Hematopoietic Progenitor Cells, Immune Cells, and Other Cellular Subsets Collected by Apheresis.
Number of participants with increase in yields of hematopoietic progenitor cells, immune cells, and other cellular subsets collected by apheresis following G-CSF and AMD3100 to mobilize stem cells.
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2004 (estimated)
- Study start18 Jun 2004
- Primary completion25 Oct 2012
- Study completion25 Oct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Richard W Childs, M.D., Principal investigator, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00082329
- Sponsor's protocol ID
- 040179
- Other IDs
- 04-H-0179
- Status last verified
- May 2021
- First submitted
- 6 May 2004
- Last updated
- 22 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Gyger M, Stuart RK, Perreault C. Immunobiology of allogeneic peripheral blood mononuclear cells mobilized with granulocyte-colony stimulating factor. Bone Marrow Transplant. 2000 Jul;26(1):1-16. doi: 10.1038/sj.bmt.1702464.
PubMed 10918400Bellucci R, De Propris MS, Buccisano F, Lisci A, Leone G, Tabilio A, de Fabritiis P. Modulation of VLA-4 and L-selectin expression on normal CD34+ cells during mobilization with G-CSF. Bone Marrow Transplant. 1999 Jan;23(1):1-8. doi: 10.1038/sj.bmt.1701522.
PubMed 10037043Mohle R, Murea S, Kirsch M, Haas R. Differential expression of L-selectin, VLA-4, and LFA-1 on CD34+ progenitor cells from bone marrow and peripheral blood during G-CSF-enhanced recovery. Exp Hematol. 1995 Dec;23(14):1535-42.
PubMed 8542944
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Blood Hematopoietic Progenitor Cell Mobilization Using Granulocyte Colony Stimulating Factor (G-CSF) Combined With AMD3100 Mozobil (Plerixafor) in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00082329
- Acronym / sponsor ID
- 040179
- Conditions
- Healthy
- Keywords
- Hematopoietic Stem Cells, PBSC's, Mobilization, Alloreactivity, T Cell Polarization, Dendritic Cells, CXCR4, Plerixafor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 18 Jun 2004 (actual)
- Primary completion
- 25 Oct 2012 (actual)
- Study completion
- 25 Oct 2012 (actual)
- First posted
- 6 May 2004 (estimated)
- Results
- Posted 2 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This 12-day study will test whether the combination of G-CSF (granulocyte-colony stimulating factor) and AMD3100 (Mozobil) is more efficient in mobilizing stem cells for collection than the use of G-CSF alone. Traditionally, the growth factor G-CSF has been given to stem cell donors to mobilize, or push, stem cells out of the bone marrow and into the blood circulation for collection for transplantation. Although a sufficient quantity of cells usually can be collected with G-CSF treatment, some donors do not respond well and may require multiple apheresis procedures (see below) to collect enough cells. Studies indicate that G-CSF used together with a drug called AMD3100 may be more effective in mobilizing stem cells for collection than G-CSF alone. The Food and Drug Administration has approved G-CSF for stem cell mobilization. AMD3100 is a new drug that also mobilizes stem cells in large numbers within a few hours.
Normal healthy volunteers between 18 and 60 years of age may be eligible for this study.
Detailed description
Peripheral blood progenitor cells (PBPC) are the most popular source of hematopoetic stem cells for allogeneic transplantation because of technical ease of collection and faster engraftment. Traditionally, granulocyte-colony stimulating factor (G-CSF) has been used to procure the peripheral blood stem cell graft. Although regimens using G-CSF usually succeed in collecting adequate numbers of PBPC from healthy donors, 5%-10% of the donors will mobilize stem cells poorly and may require multiple large volume apheresis or bone marrow harvesting. AMD3100 reversibly inhibits CXC- chemokine receptor 4 (CXCR4) binding to stromal cell derived factor (SDF) - 1 and was recently discovered to be an effective agent to mobilize cluster of differentiation 34 (CD34)+ cells into the peripheral blood. In normal volunteers, administering AMD3100 after 4-5 days of G-CSF resulted in a 3-3.5 fold increase in circulating CD34 cells compared to G-CSF alone. Recent data has suggested that the combination of G-CSF and AMD3100 is superior to G-CSF alone for mobilizing hematopoietic progenitor cells in heavily pretreated patients with multiple myeloma or non-Hodgkin's lymphoma undergoing autologous hematopoietic transplantation. Combining AMD3100 with G-CSF could be an effective strategy to improve the yield of PBPC collected from allogeneic donors who mobilize poorly with G-CSF alone. However, the biological impact of AMD3100 in this context on T cells and other cellular populations contained within the allograft that mediate graft versus host disease (GVHD) and graft-versus-leukemia (GVL) effects are unknown.
We propose to collect peripheral progenitor cell (PBPC) from healthy volunteers following 5 days of G-CSF (10 mcg/kg/day) and a single dose of AMD3100 (240 mcg/kg subcutaneous given 12 hours before starting apheresis) to study the impact of combining these two mobilizing agents on the immunological properties of the mobilized cells. A single 15 liter apheresis will be conducted on day 5 following the 5th dose of G-CSF. The immunological studies conducted on these mobilized cells will be the same as our parallel study which is investigating the immune properties of PBPCs mobilized with G-CSF or AMD3100 alone. If combining AMD3100 with G-CSF has no negative impact on the immune populations involved in GVHD and graft-vs-leukemia effects, this regimen could be used for allogeneic donors who fail to mobilize sufficient peripheral blood stem cell (PBSC) using G-CSF alone.
Primary objective: To determine the cytokine polarization status of cluster of differentiation 4 (CD4+) T-cells collected by apheresis following combination of AMD3100 and G-CSF compared to G-CSF mobilization.
Primary endpoint: the ratio of Th1 [intracellular interferon (IFN-g) +] versus Th2 [intracellular interleukin (IL-4+)] T-cells in the apheresis products collected from individual donors undergoing mobilization with combination of G-CSF and AMD3100 to the ratio in apheresis product collected with G-CSF alone (ratio published in literature).
Secondary endpoints: To examine 1) the cellular content and other immune properties of mobilized cells; 2) yields of hematopoietic progenitor cells, immune cells, and other cellular subsets collected by apheresis; and the 3) safety profile of AMD3100.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| G-CSF and AMD3100 to Mobilize Stem Cells in Healthy Volunteers | Experimental | Drug: AMD 3100 (Mozobil plerixafor), Drug: Granulocyte colony-stimulating factor (G-CSF)Participants received subcutaneous injection of G-CSF (10 mcg/kg/day) for 5 days followed by a single subcutaneous injection of AMD3100 (240 mcg/kg) given 12 hours prior to apheresis peripheral blood stem cell collection. Peripheral blood stem cell collection performed on the fifth day of G-CSF administration. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy volunteers greater or equal to 18 years old, less than or equal to 60 years.
- Weight greater than 60 kg (132 pounds)
- Normal renal function: creatinine less than 1.5 mg/dl l
- Normal liver function: bilirubin less than1.5mg/dl, transaminases within normal limit
- Normal blood count: white blood cell (WBC) 3000-10000/mm3, granulocytes greater than 1500/mm3, platelets greater than 150,000/mm3, hemoglobin greater than 12.5g/dl
Key exclusion criteria (11 listed)
- Active infection or history of recurrent infection or positive test for syphilis (RPR), hepatitis B and C (HBaSAg, Anti-HCV), HIV and human T- Lymphocytic virus (HTLV-1)
- History of autoimmune disease such as rheumatoid arthritis, systemic lupus erythematous
- History of cancer within the past 5 years excluding basal cell or squamous cell carcinoma of the skin
- History of any hematologic disorders including thromboembolic disease
- History of cardiac disease such as uncontrolled hypertension, peripheral vascular disease, myocardial infarction, cardiac arrhythmias or related symptoms such as tachycardia, chest pain, shortness of breath which have required medical intervention or treatment or a Framingham coronary disease risk prediction score of greater than 10% 10 year coronary heart disease (CHD) risk
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 |
|---|---|---|
| AMD 3100 (Mozobil plerixafor)Also: AMD 3100Participants received subcutaneous injection of granulocyte colony-stimulating factor (G-CSF) at 10 mcg/kg/day for 5 days followed by a single subcutaneous injection of AMD3100 (240 mcg/kg) given 12 hours prior to apheresis peripheral blood stem cell collection. Peripheral blood stem cell collection performed on the fifth day of G-CSF administration. | Drug | G-CSF and AMD3100 to Mobilize Stem Cells in Healthy Volunteers |
| Granulocyte colony-stimulating factor (G-CSF)Also: G-CSFParticipants received subcutaneous injection of granulocyte colony-stimulating factor (G-CSF) at 10 mcg/kg/day for 5 days followed by a single subcutaneous injection of AMD3100 (240 mcg/kg) given 12 hours prior to apheresis peripheral blood stem cell collection. Peripheral blood stem cell collection performed on the fifth day of G-CSF administration. | Drug | G-CSF and AMD3100 to Mobilize Stem Cells in Healthy Volunteers |
Primary outcome
Number of Participants With Successful Apheresis Collection Following Combination of AMD3100 and G-CSF.
Time frame: Day 1 (cells are counted 24 hours after AMD3100)
Healthy volunteers will be administered AMD 3100 (Mozobil plerixafor) and granulocyte colony stimulating factor (G-CSF) to determine cytokine polarization status of cluster of differentiation (CD 4) T-cells collected by apheresis. We propose that the combination of single dose AMD 3100 and G-CSF as combined mobilizing agents will improve the peripheral blood progenitor cells mobilization. Successful treatment responders is defined by completing study treatment with cell mobilization and cell collection. Non-responders is defined by having completed the study treatment and having cell mobilization without cell collection.
2 secondary outcomes
Average Fold Change From Baseline of Mobilized Cells Following G-CSF and AMD3100 to Mobilize Stem Cells in Healthy Volunteers
Time frame: Day 7
Number of Participants With Increased the Levels of Circulating Hematopoietic Progenitor Cells, Immune Cells, and Other Cellular Subsets Collected by Apheresis.
Time frame: Day 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 10918400Gyger M, Stuart RK, Perreault C. Immunobiology of allogeneic peripheral blood mononuclear cells mobilized with granulocyte-colony stimulating factor. Bone Marrow Transplant. 2000 Jul;26(1):1-16. doi: 10.1038/sj.bmt.1702464.
- Background: PubMed 10037043Bellucci R, De Propris MS, Buccisano F, Lisci A, Leone G, Tabilio A, de Fabritiis P. Modulation of VLA-4 and L-selectin expression on normal CD34+ cells during mobilization with G-CSF. Bone Marrow Transplant. 1999 Jan;23(1):1-8. doi: 10.1038/sj.bmt.1701522.
- Background: PubMed 8542944Mohle R, Murea S, Kirsch M, Haas R. Differential expression of L-selectin, VLA-4, and LFA-1 on CD34+ progenitor cells from bone marrow and peripheral blood during G-CSF-enhanced recovery. Exp Hematol. 1995 Dec;23(14):1535-42.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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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.
Richard W Childs, M.D. principal investigator
National Heart, Lung, and Blood Institute (NHLBI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AMD 3100 (Mozobil plerixafor) and Granulocyte colony-stimulating factor (G-CSF) in people with Healthy, run by National Heart, Lung, and Blood Institute (NHLBI) 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 7 inclusion and 11 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 22 Jul 2021. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Successful Apheresis Collection Following Combination of AMD3100 and G-CSF. (time frame: Day 1 (cells are counted 24 hours after AMD3100)). 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 NCT00082329, 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 22 Jul 2021.