Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00082329
Status:
COMPLETED
Last Update Posted:
2021-07-22
First Post:
2004-05-06
Brief Title:
G-CSF and AMD3100 to Mobilize Stem Cells in Healthy Volunteers
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Peripheral Blood Hematopoietic Progenitor Cell Mobilization Using Granulocyte Colony Stimulating Factor G-CSF Combined With AMD3100 Mozobil Plerixafor in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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 3-35 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-Hodgkins 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 mcgkgday and a single dose of AMD3100 240 mcgkg 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
We propose to collect peripheral progenitor cell PBPC from healthy volunteers following 5 days of G-CSF 10 mcgkgday and a single dose of AMD3100 240 mcgkg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 04-H-0179 | OTHER | NIH NHLBI | None |