Evaluation of the Drug Plerixafor in Combination With Chemotherapy and G-CSF for Stem Cell Collection
The purpose of this study is to test whether the addition of the drug plerixafor to treatment with chemotherapy and G-CSF can better activate your bone marrow stem cells to improve the chances of transplant. The study will look for the activation of a certain type of blood cell, called CD34+ cells in patients who receive plerixafor, chemotherapy and G-CSF. The investigators will follow the number of patients that achieve the target numbers of CD34+ cells. The number of patients achieving the target level of CD34+ cells, and the total number of CD34+ cells, will be compared to the numbers in previous studies testing just chemotherapy and G-CSF, without plerixafor.
The investigators will also test the safety of the combination of plerixafor with chemotherapy and G-CSF and look at the success of the transplantation after 12 months.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of Plerixafor (Mozobil ™, AMD3100) in Combination With Chemotherapy and G-CSF for CD34+ Cell Mobilization|
- Patients Achieving Greater Than or Equal to 5 x 10^6 of CD34+ Cells/kg in a Single Day of Apheresis [ Time Frame: Within the first 4 days following the first dose of Plerixafor ] [ Designated as safety issue: Yes ]
- Patients Achieving >= 3 X 10^6 CD34+ Cell/Kg [ Time Frame: Within the first 4 days following the first dose of Plerixafor ] [ Designated as safety issue: Yes ]
- Average Number of Days for Engraftment (Engraftment Defined as Absolute Neutrophil Count>500) [ Time Frame: Within the first 4 days following the first dose of Plerixafor ] [ Designated as safety issue: No ]
|Study Start Date:||March 2010|
|Study Completion Date:||February 2014|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Plerixafor + Chemo and G-CSF
Patients who receive a combination of Plerixafor, chemotherapy and G-CSF.
240 µg/kg subcutaneous injection on the day that the absolute neutrophil count (ANC) is > 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01095757
|United States, Georgia|
|Emory University Winship Cancer Institute|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Edmund Waller, MD, PhD||Emory University Winship Cancer Institute|