Ignite Creation Date:
2024-05-05 @ 9:30 PM
Last Modification Date:
2024-10-26 @ 10:05 AM
Study NCT ID:
NCT00901225
Status:
COMPLETED
Last Update Posted:
2014-05-07
First Post:
2009-05-04
Brief Title:
Study of Plerixafor for Rescue of Poor Mobilizers in Autologous Stem Cell Transplant
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Plerixafor Rescue Mobilization For Autologous Stem Cell Transplant Patients With Inadequate Response to G-CSF
Status:
COMPLETED
Status Verified Date:
2014-04
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 administered at a dose of 240 ugkg potentiates the effect of granulocyte colony-stimulating factor G-CSF to increase peripheral blood progenitor cells in both healthy volunteers and cancer patients Furthermore in cancer patients cells collected via apheresis using Plerixafor and G-CSF have been successfully transplanted In December 2008 Plerixafor received approval from the Food and Drug administration for use in combination with G-CSF to aid in mobilization of progenitor cells for apheresis The proposed study is not designed to support approval of a new indication or change in the advertising for Plerixafor The route of administration and dosage level are identical to that which is listed on the package insert Although Plerixafor is not approved for patients with Hodgkins Lymphoma there is no known or theoretic increased risk of the use of this drug in this patient population
The study hypothesis for this study is that patients with a circulating CD34 count 20 cellsul after 5 days of mobilization with G-CSF alone will achieve or equal to 2 X 106CD34 cellskg within 3 days of apheresis after receiving Plerixafor with G-CSF
The study hypothesis for this study is that patients with a circulating CD34 count 20 cellsul after 5 days of mobilization with G-CSF alone will achieve or equal to 2 X 106CD34 cellskg within 3 days of apheresis after receiving Plerixafor with G-CSF
Detailed Description:
This is a single-center Phase 2 open-label study All patients diagnosed with non-hodgkins lymphoma hodgkins disease or multiple myeloma and candidates for autologous transplantation are eligible to enter into the study The only change to the standard of care is the addition of 240 ugkg Plerixafor following 5 days of G-CSF mobilization
The results of the study will provide both numeric and categorical estimates of measurements of the safety and efficacy of Plerixafor The primary efficacy endpoint Treatment Success is a binary response variable categorizing whether the patient was able to mobilize at least 2 X 106 CD34 cellskg within 3 days of apheresis
The percentage of patients achieving Treatment Success will be summarized All AEs will be followed for 30 days after the last apheresis or until the first dose of ablative chemotherapy whichever occurs first All SAEs will be followed for 6 months post-transplant or until relapse All patients who receive at least one dose of Plerixafor will be included in all summaries of AEs
The results of the study will provide both numeric and categorical estimates of measurements of the safety and efficacy of Plerixafor The primary efficacy endpoint Treatment Success is a binary response variable categorizing whether the patient was able to mobilize at least 2 X 106 CD34 cellskg within 3 days of apheresis
The percentage of patients achieving Treatment Success will be summarized All AEs will be followed for 30 days after the last apheresis or until the first dose of ablative chemotherapy whichever occurs first All SAEs will be followed for 6 months post-transplant or until relapse All patients who receive at least one dose of Plerixafor will be included in all summaries of AEs
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