Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00444912
Status:
COMPLETED
Last Update Posted:
2014-03-13
First Post:
2007-03-07
Brief Title:
The Effect of Rituximab on Mobilization With AMD3100 Plerixafor Plus G-CSF in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma NHL or Hodgkin Disease HD
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
A Pilot Cohort Study of AMD3100 in Combination With G-CSF and Rituximab Compared With AMD3100 in Combination With G-CSF Alone for Mobilization of BPCs in Patients With Relapsed or Refractory NHL or HD Prior to Autologous HPC Transplant
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:
Participants with non-Hodgkin lymphoma NHL or Hodgkin disease HD will be assigned to one of 2 arms based on the immunophenotype of their lymphoma
AParticipants with CD20- lymphoma will undergo mobilization with granulocyte colony-stimulating factor G-CSF and plerixafor
B Participants with CD20 lymphomas will undergo mobilization with rituximab G-CSF and plerixafor They will receive a weekly dose of rituximab beginning 1 week prior to and continuing until 2 weeks after the first dose of G-CSF
Participants in both groups will receive G-CSF twice daily for 4 days In the evening on Day 4 a dose of plerixafor will be administered Apheresis will be initiated the next morning Participants will continue to receive G-CSF twice daily and to receive the evening dose of plerixafor followed by apheresis the next morning for up to a total of 4 aphereses or until 5106 CD34 cellskg are collected
Participants who are transplanted will be monitored for the time to polymorphonuclear leukocytes PMN platelets PLT and lymphocyte engraftment Follow-up assessments will be done at 100 days and 6 and 12 months post-transplantation
AParticipants with CD20- lymphoma will undergo mobilization with granulocyte colony-stimulating factor G-CSF and plerixafor
B Participants with CD20 lymphomas will undergo mobilization with rituximab G-CSF and plerixafor They will receive a weekly dose of rituximab beginning 1 week prior to and continuing until 2 weeks after the first dose of G-CSF
Participants in both groups will receive G-CSF twice daily for 4 days In the evening on Day 4 a dose of plerixafor will be administered Apheresis will be initiated the next morning Participants will continue to receive G-CSF twice daily and to receive the evening dose of plerixafor followed by apheresis the next morning for up to a total of 4 aphereses or until 5106 CD34 cellskg are collected
Participants who are transplanted will be monitored for the time to polymorphonuclear leukocytes PMN platelets PLT and lymphocyte engraftment Follow-up assessments will be done at 100 days and 6 and 12 months post-transplantation
Detailed Description:
This is a single-center 2-arm non-randomized open-label study to evaluate the safety of plerixafor when used in combination with rituximab Rituxan and granulocyte colony-stimulating factor G-CSF in patients with relapsed or refractory Hodgkin disease HD or non-Hodgkin lymphoma NHL
Participants will be assigned to one of 2 arms based on the immunophenotype of their lymphoma
AParticipants with CD20- lymphoma will undergo mobilization with G-CSF and plerixafor
B Participants with CD20 lymphomas will undergo mobilization with rituximab G-CSF and plerixafor They will receive a weekly dose of 375 mgm2 rituximab by intravenous iv infusion beginning 1 week prior to and continuing until 2 weeks after the first dose of G-CSF
Participants in both groups will receive 75 µgkg G-CSF twice daily morning and evening for 4 days In the evening approximately 1000 pm on Day 4 a dose of plerixafor 240 µgkg will be administered Apheresis will be initiated the next morning approximately 10 to 11 hours after plerixafor is given Participants will continue to receive G-CSF twice daily and to receive the evening dose of plerixafor followed by apheresis the next morning for up to a total of 4 aphereses or until 5106 CD34 cellskg are collected
Participants with an adequate number of autologous peripheral blood stem cells PBSCs collected by apheresis will be admitted to the study center for the administration of high-dose chemotherapy and autologous transplantation After transplantation the times to PMN PLT and lymphocyte engraftment will be measured Participants will remain hospitalized until they achieve an absolute granulocyte count of 500µl in the peripheral blood Graft durability will be assessed at 100 days and 6 and 12 months post-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
Participants will be assigned to one of 2 arms based on the immunophenotype of their lymphoma
AParticipants with CD20- lymphoma will undergo mobilization with G-CSF and plerixafor
B Participants with CD20 lymphomas will undergo mobilization with rituximab G-CSF and plerixafor They will receive a weekly dose of 375 mgm2 rituximab by intravenous iv infusion beginning 1 week prior to and continuing until 2 weeks after the first dose of G-CSF
Participants in both groups will receive 75 µgkg G-CSF twice daily morning and evening for 4 days In the evening approximately 1000 pm on Day 4 a dose of plerixafor 240 µgkg will be administered Apheresis will be initiated the next morning approximately 10 to 11 hours after plerixafor is given Participants will continue to receive G-CSF twice daily and to receive the evening dose of plerixafor followed by apheresis the next morning for up to a total of 4 aphereses or until 5106 CD34 cellskg are collected
Participants with an adequate number of autologous peripheral blood stem cells PBSCs collected by apheresis will be admitted to the study center for the administration of high-dose chemotherapy and autologous transplantation After transplantation the times to PMN PLT and lymphocyte engraftment will be measured Participants will remain hospitalized until they achieve an absolute granulocyte count of 500µl in the peripheral blood Graft durability will be assessed at 100 days and 6 and 12 months post-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