Ignite Creation Date:
2024-05-06 @ 12:58 AM
Last Modification Date:
2024-10-26 @ 10:57 AM
Study NCT ID:
NCT01700608
Status:
COMPLETED
Last Update Posted:
2012-10-04
First Post:
2012-10-01
Brief Title:
Prospective Observational Study on Plerixafor After Chemotherapy
Sponsor:
Fondazione IRCCS Istituto Nazionale dei Tumori Milano
Organization:
Fondazione IRCCS Istituto Nazionale dei Tumori Milano
Study Overview
Official Title:
Prospective Observational Study on Plerixafor After Chemotherapy
Status:
COMPLETED
Status Verified Date:
2012-10
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:
Plerixafor is a new CXCR4 inhibitor that is able to improve peripheral blood stem cell PBSC mobilization when combined with granulocyte-colony-stimulating factor G-CSF The on demand use of plerixafor at the hematopoietic recovery after chemotherapy G-CSF may be more efficient and cost-effective but the timing of administration and criteria for patient selection are still under investigation We collected the data of lymphoma and myeloma patients treated with plerixafor at the hematopoietic recovery after chemotherapy G-CSF The decision of adding plerixafor was based on PB CD34 cells at the time of hematopoietic recovery after chemotherapy in patients at their first or subsequent attempt according to the attending physician choice The primary endpoint was the assessment of the rate of patients who were able to collect 2 x 106 CD34kg
Detailed Description:
Plerixafor is a new CXCR4 inhibitor that is able to improve peripheral blood stem cell PBSC mobilization when combined with granulocyte-colony-stimulating factor G-CSF The on demand use of plerixafor at the hematopoietic recovery after chemotherapy G-CSF may be more efficient and cost-effective but the timing of administration and criteria for patient selection are still under investigation We collected the data of lymphoma and myeloma patients treated with plerixafor at the hematopoietic recovery after chemotherapy G-CSF The decision of adding plerixafor was based on PB CD34 cells at the time of hematopoietic recovery after chemotherapy in patients at their first or subsequent attempt according to the attending physician choice The primary endpoint was the assessment of the rate of patients who were able to collect 2 x 106 CD34kg Secondary endpoint was the assessment of the rate of patients collecting 4 x 106 CD34kg and the median number of apheresis to reach the target
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