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|
- Proportion of patients achieving the target number of either 5 x 106 (lymphoma) or 10 x 106 (myeloma) 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: No ]
- Total numbers of CD34+ cells/kg collected, mean numbers of days of apheresis needed to collect the target numbers of CD34+ cells/kg , neutrophil and platelet engraftment and graft durability at 12 months post transplant [ Time Frame: Within the first 4 days following the first dose of Plerixafor ] [ Designated as safety issue: No ]
|Study Start Date:||March 2010|
|Estimated Study Completion Date:||November 2013|
|Estimated Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
Patients who receive a combination of Plerixafor, chemotherapy and G-CSF vs. a historical group of control patients who received chemotherapy and G-CSF alone.
240 µg/kg subcutaneous injection on the day that the 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.
Study is ongoing; no interim analysis.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01095757
|Contact: Edmund Waller, MD, PhDfirstname.lastname@example.org|
|United States, Georgia|
|Emory University Winship Cancer Institute||Recruiting|
|Atlanta, Georgia, United States, 30322|
|Contact: Edmund Waller, MD, PhD 888-946-7447 email@example.com|
|Principal Investigator:||Edmund Waller, MD, PhD||Emory University Winship Cancer Institute|