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| ID | Type | Description | Link |
|---|---|---|---|
| WCI1680-09 | Other Identifier | Other |
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| Name | Class |
|---|---|
| Genzyme, a Sanofi Company | INDUSTRY |
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Typically, the collection of blood cells for autologous stem cell transplant is done after the drugs granulocyte colony-stimulating factor (G-CSF) and plerixafor have been given to activate the bone marrow stem cells to produce a certain type of blood cell, called CD34+ cells. Currently, plerixafor is given in the evening, about 11 hours before apheresis (removal of blood) begins the following morning. The purpose of this study is to test whether plerixafor can instead be given 17 hours before apheresis. This timing would be more convenient since plerixafor would be given during normal clinic hours, and so patients would be within a clinic environment if any side effects develop.
The study will look for the activation of CD34+ cells in patients who receive plerixafor 17 hours before apheresis. We will follow the number of patients that achieve the target numbers of CD34+ cells, and the total number of CD34+ cells collected. These will be compared to the numbers in previous studies giving plerixafor 11 hours before apheresis.
We will also assess the safety of giving plerixafor 17 hours before apheresis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plerixafor 17 hours prior to apheresis | Experimental | Dosing of plerixafor will occur at 3PM (1500 hours). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plerixafor | Drug | Plerixafor 240 mcg/kg SC will be administered daily starting on the first day of stem cell apheresis, up to a total of 4 doses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Who Collected ≥ 6 x 10^6 CD34+ Cells by Day 5 (4 Apheresis Sessions) With Plerixafor Administration at 1500. | Within the first 5 days following plerixafor initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Who on Day 1 Collected > 10 x 10^6 CD34+ Cells/kg Following Plerixafor Dosing at 1500 Hrs | Within the first 5 days following plerixafor initiation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| R. Donald Harvey, PharmD, FCCP | Emory University Winship Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Winship Cancer Institute | Atlanta | Georgia | 30322 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Plerixafor 17 Hours Prior to Apheresis | Dosing of plerixafor will occur at 3PM (1500 hours). Plerixafor : Plerixafor 240 mcg/kg SC will be administered daily starting on the first day of stem cell apheresis, up to a total of 4 doses. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Plerixafor 17 Hours Prior to Apheresis | Dosing of plerixafor will occur at 3PM (1500 hours). Plerixafor : Plerixafor 240 mcg/kg SC will be administered daily starting on the first day of stem cell apheresis, up to a total of 4 doses. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients Who Collected ≥ 6 x 10^6 CD34+ Cells by Day 5 (4 Apheresis Sessions) With Plerixafor Administration at 1500. | Posted | Number | Participants | Within the first 5 days following plerixafor initiation |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Plerixafor 17 Hours Prior to Apheresis | Dosing of plerixafor will occur at 3PM (1500 hours). Plerixafor : Plerixafor 240 mcg/kg SC will be administered daily starting on the first day of stem cell apheresis, up to a total of 4 doses. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypokalemia | Blood and lymphatic system disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bone Pain | Musculoskeletal and connective tissue disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Harvey | Emory University | 404-778-4381 | rdharve@emory.edu |
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| ID | Term |
|---|---|
| C088327 | plerixafor |
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|
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
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| Secondary | Number of Patients Who on Day 1 Collected > 10 x 10^6 CD34+ Cells/kg Following Plerixafor Dosing at 1500 Hrs | Posted | Number | Participants | Within the first 5 days following plerixafor initiation |
|
|
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| 2 |
| 31 |
| 26 |
| 31 |
| Bone Pain | Musculoskeletal and connective tissue disorders |
|
| Nausea | General disorders |
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| Injection site reactions | Surgical and medical procedures |
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| hypokalemia | Blood and lymphatic system disorders |
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| Diarrhea | Gastrointestinal disorders |
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| Dizziness | General disorders |
|
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