Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00291811
Status:
APPROVED_FOR_MARKETING
Last Update Posted:
2014-02-11
First Post:
2006-02-13
Brief Title:
Access Program for Use of AMD3100 to Increase Peripheral Blood Stem Cells for Transplantation in Patients Who Have Failed Standard Therapy Stem Cell Mobilization
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
Compassionate Use Protocol for the Use of AMD3100 to Mobilize Peripheral Blood Stem Cells for Collection and Transplantation
Status:
APPROVED_FOR_MARKETING
Status Verified Date:
2014-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CUP
Brief Summary:
The purpose of this program is to provide access to AMD3100 for patients who would benefit from an autologous stem cell transplant but who have either previously failed to collect enough cells for transplant following standard therapy or are not considered by their physician to have a reasonable chance of collecting enough cells for transplant
Detailed Description:
The purpose of this program is to provide access to AMD3100 for patients who would benefit from an autologous stem cell transplant but who have either previously failed to collect enough cells for transplant following standard therapy or are not considered by their physician to have a reasonable chance of collecting enough cells for transplant
Compassionate use is a way to provide experimental treatment to a patient who is not eligible to receive that therapy in a clinical trial but who has a serious or life-threatening illness for which other treatments are not available
Peripheral blood stem cells are obtained by apheresis following a stem cell mobilization regimen The standard of care regimen for stem cell mobilization includes a growth factor G-CSF AMD3100 is given in addition to G-CSF prior to each apheresis session If enough peripheral blood stem cells for transplant are collected the patient is treated with high dose chemotherapy in preparation for transplant and is transplanted with cells obtained from the AMD3100 and G-CSF regimen Patients are followed for safety and transplant outcomes for up to 12 months after transplant
Compassionate use is a way to provide experimental treatment to a patient who is not eligible to receive that therapy in a clinical trial but who has a serious or life-threatening illness for which other treatments are not available
Peripheral blood stem cells are obtained by apheresis following a stem cell mobilization regimen The standard of care regimen for stem cell mobilization includes a growth factor G-CSF AMD3100 is given in addition to G-CSF prior to each apheresis session If enough peripheral blood stem cells for transplant are collected the patient is treated with high dose chemotherapy in preparation for transplant and is transplanted with cells obtained from the AMD3100 and G-CSF regimen Patients are followed for safety and transplant outcomes for up to 12 months after transplant
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