Ignite Creation Date:
2024-05-05 @ 7:46 PM
Last Modification Date:
2024-10-26 @ 9:53 AM
Study NCT ID:
NCT00733824
Status:
COMPLETED
Last Update Posted:
2017-03-09
First Post:
2008-08-11
Brief Title:
Intravenous AMD3100 for Collection of Autologous Peripheral Blood Stem Cells in Patients With Lymphoma
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
A Phase III Study of Intravenous AMD3100 Added to a Mobilization Regimen of G-CSF to Increase the Number of Autologous Peripheral Blood Stem Cells Collected From Patients With Lymphoma
Status:
COMPLETED
Status Verified Date:
2017-01
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 study will evaluate the safety and efficacy of intravenous AMD3100 added to a standard G-CSF mobilization regimen of patients undergoing autologous stem cell transplantation for lymphoma
The investigators hypothesize that after stem cell mobilization with G-CSF plus IV AMD3100 a significantly higher proportion of lymphoma patients will collect 2 x 10E6 CD34 cellskg
The investigators hypothesize that after stem cell mobilization with G-CSF plus IV AMD3100 a significantly higher proportion of lymphoma patients will collect 2 x 10E6 CD34 cellskg
Detailed Description:
Autologous stem cell transplantation ASCT is indicated for patients with non-Hodgkin lymphoma NHL or Hodgkin lymphoma HL who have primary progressive disease or who relapse after a chemotherapy-induced complete remission For these patients as for other patients undergoing autologous transplantation the number of CD34 cells collected is a reliable predictor of neutrophil and platelet PLT engraftment after transplantation
AMD3100 plerixafor is a promising new mobilizing agent that has demonstrated efficacy in patients with NHL HL and multiple myeloma MM Although efficacious the subcutaneous dosing of AMD3100 requires that patients receive the drug in the evening prior to apheresis which can present logistical problems Intravenous dosing of AMD3100 may result in a faster rise in peripheral CD34 cell count so that the drug can be administered the same day as apheresis Intravenous dosing may also increase the peak CD34 cell count improving the number of CD34 cells collected via apheresis
This Phase III study will evaluate the safety and efficacy of intravenous AMD3100 added to the standard G-CSF mobilization regimen of patients undergoing autologous stem cell transplantation for Hodgkin and non-Hodgkin lymphomas
AMD3100 plerixafor is a promising new mobilizing agent that has demonstrated efficacy in patients with NHL HL and multiple myeloma MM Although efficacious the subcutaneous dosing of AMD3100 requires that patients receive the drug in the evening prior to apheresis which can present logistical problems Intravenous dosing of AMD3100 may result in a faster rise in peripheral CD34 cell count so that the drug can be administered the same day as apheresis Intravenous dosing may also increase the peak CD34 cell count improving the number of CD34 cells collected via apheresis
This Phase III study will evaluate the safety and efficacy of intravenous AMD3100 added to the standard G-CSF mobilization regimen of patients undergoing autologous stem cell transplantation for Hodgkin and non-Hodgkin lymphomas
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None