Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00396331
Status:
COMPLETED
Last Update Posted:
2014-03-13
First Post:
2006-11-02
Brief Title:
AMD3100 Plerixafor With G-CSF in Poor Mobilizing Adult Patients Who Previously Failed Hematopoietic Stem Cell HSC CollectionAttempts
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
A Phase 2 Multicenter Open-label Study to Evaluate the Safety and Efficacy of AMD3100 240 µgkg Added to a G-CSF Mobilization Regimen in Poor Mobilizing Adult Patients Who Have Previously Failed Stem Cell CollectionAttempts
Status:
COMPLETED
Status Verified Date:
2014-02
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 evaluates the safety efficacy and pharmacokinetics PK of plerixafor given in addition to granulocyte-colony stimulating factor G-CSF for collection of peripheral blood stem cells PBSCs for autologous transplantation in patients who would benefit from an autologous stem cell transplant but have failed previous collections or collection attempts with a mobilization regimen of G-CSF alone chemotherapy and G-CSF or any other conventional therapy including cytokines chemotherapy and cytokines and bone marrow harvests
The only change to standard of care of a mobilization regimen that includes G-CSF is the addition of a dose of AMD3100 plerixafor on the evening prior to each day of apheresis
Efficacy outcomes include quantification of CD34 cells in the apheresis product and assessment of successful polymorphonuclear leukocyte PMN and platelet PLT engraftment after transplantation PK outcomes include analysis of repeated doses of plerixafor
The only change to standard of care of a mobilization regimen that includes G-CSF is the addition of a dose of AMD3100 plerixafor on the evening prior to each day of apheresis
Efficacy outcomes include quantification of CD34 cells in the apheresis product and assessment of successful polymorphonuclear leukocyte PMN and platelet PLT engraftment after transplantation PK outcomes include analysis of repeated doses of plerixafor
Detailed Description:
This is a Phase 2 multicenter prospective open-label study Once 70 patients have enrolled subsequent patients enrolled should have a diagnosis of lymphoma Patients who would benefit from an autologous stem cell transplant who have failed previous collections or collection attempts with a mobilization regimen of granulocyte colony-stimulating factor G-CSF alone chemotherapy and G-CSF or any other conventional therapy including cytokines chemotherapy and cytokines and bone marrow harvests and who meet the inclusionexclusion criteria are eligible to receive plerixafor as outlined in this protocol The only change to standard of care of a mobilization regimen that includes G-CSF is the addition of a dose of plerixafor on the evening prior to each day of apheresis
Patients will undergo mobilization with G-CSF 10 µgkg for 4 days On Day 4 plerixafor 240 µgkg will be administered in the evening prior to the first apheresis and each subsequent evening prior to apheresis thereafter such that there is a 10 to 11 hour interval between dosing and the initiation of apheresis Patients will continue to receive G-CSF on each day of apheresis Patients will undergo a minimum of 2 and a maximum of 7 aphereses or until 2106 CD34 cellskg are collected whichever occurs first In addition the mobilization of NHL tumor cells and the pharmacokinetics of repeat doses of plerixafor will be examined
After the last apheresis has been completed or after the patient has collected 2106 CD34 cellskg heshe will be treated with high-dose chemotherapy in preparation for transplantation Patients will be transplanted with cells obtained from the G-CSF with plerixafor mobilization regimen In the event that the minimum number of 2106 cells for transplantation are not obtained from the first mobilization with plerixafor cells may be retained and pooled for transplantation with those from a second mobilization with plerixafor or from prior mobilization with other agents at the investigators discretion If a second mobilization with plerixafor is attempted a minimum rest interval of one week should be allowed between the last apheresis of the first regimen and the first dose of G-CSF of the second The number of CD34 cells mobilized in the peripheral blood PB collected in the apheresis product and the number of apheresis sessions performed will be measured Success of the transplantation will be evaluated by the time to engraftment of polymorphonuclear leukocytes PMN and platelets PLT Participants will be assessed for durability of their transplant for 12 months after transplantation
This study was previously posted by AnorMED Inc In November 2006 AnorMED Inc was acquired by Genzyme Corporation Genzyme Corporation is the sponsor of the trial
Patients will undergo mobilization with G-CSF 10 µgkg for 4 days On Day 4 plerixafor 240 µgkg will be administered in the evening prior to the first apheresis and each subsequent evening prior to apheresis thereafter such that there is a 10 to 11 hour interval between dosing and the initiation of apheresis Patients will continue to receive G-CSF on each day of apheresis Patients will undergo a minimum of 2 and a maximum of 7 aphereses or until 2106 CD34 cellskg are collected whichever occurs first In addition the mobilization of NHL tumor cells and the pharmacokinetics of repeat doses of plerixafor will be examined
After the last apheresis has been completed or after the patient has collected 2106 CD34 cellskg heshe will be treated with high-dose chemotherapy in preparation for transplantation Patients will be transplanted with cells obtained from the G-CSF with plerixafor mobilization regimen In the event that the minimum number of 2106 cells for transplantation are not obtained from the first mobilization with plerixafor cells may be retained and pooled for transplantation with those from a second mobilization with plerixafor or from prior mobilization with other agents at the investigators discretion If a second mobilization with plerixafor is attempted a minimum rest interval of one week should be allowed between the last apheresis of the first regimen and the first dose of G-CSF of the second The number of CD34 cells mobilized in the peripheral blood PB collected in the apheresis product and the number of apheresis sessions performed will be measured Success of the transplantation will be evaluated by the time to engraftment of polymorphonuclear leukocytes PMN and platelets PLT Participants will be assessed for durability of their transplant for 12 months after transplantation
This study was previously posted by AnorMED Inc In November 2006 AnorMED Inc was acquired by Genzyme Corporation Genzyme Corporation is the sponsor of the trial
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