Ignite Creation Date:
2024-05-06 @ 10:24 AM
Last Modification Date:
2024-10-26 @ 12:29 PM
Study NCT ID:
NCT03244930
Status:
UNKNOWN
Last Update Posted:
2017-08-10
First Post:
2017-08-07
Brief Title:
Low Dose Plerixafor Plus G-CSF in Mobilizing Stem Cells for Autologous Peripheral Blood Transplantation
Sponsor:
Hospital Universitario Dr Jose E Gonzalez
Organization:
Hospital Universitario Dr Jose E Gonzalez
Study Overview
Official Title:
Low Dose Plerixafor Plus G-CSF Efficiency in Mobilizing Stem Cells From Lymphoma and Myeloma Patients for Autologous Peripheral Blood Transplantation
Status:
UNKNOWN
Status Verified Date:
2017-08
Last Known Status:
RECRUITING
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:
Plerixafor is added to mobilizing chemotherapy and G-CSF to overcome poor stem cell mobilization We want to demonstrate that half of the commonly prescribed dose can be safely administered once as a single dose in first attempt leading to apheresis yields of 2 x 106 CD34 cellskg body weight
Detailed Description:
Plerixafor is added to mobilizing chemotherapy and G-CSF to overcome poor stem cell mobilization Consecutive patients in autologous transplant protocol will receive mobilization consisted of daily subcutaneously G-CSF 10 mgkg for 4 days and plerixafor 012 mgkg as a single dose 11 hours prior to initiation of apheresis HSC collection was performed with a Cobe Spectra or Spectra Optia apheresis system The planned target blood volume to be processed will be 4-fold total blood volume calculated according to patients weight and size Peripheral blood CD34 counts will be analyzed using flow cytometry For each ASCT we aimed for target yields of at least 2 x 106 CD34cellskg Toxicities and engraftment will be documented
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None