Study of the Detection of Lymphoblasts by a Novel Magnetic Needle and Nanoparticles in Patients With Leukemia
The purpose of this study is to determine if the magnetic needle, in combination with magnetic nanoparticles can accurately identify minimal residual disease in leukemia patients.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
- Lymphoblast percent [ Time Frame: 1 day ] [ Designated as safety issue: No ]Lymphoblast percent calculated before exposure to needle and of the needle enhanced sample
- SQUID magnetometry [ Time Frame: 1 day ] [ Designated as safety issue: No ]Magnetic Signal from the nanoparticles bound to the leukemia cells
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||January 2013|
|Estimated Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
Experimental: Magnetic Needle
Patients whose bone marrow aspirates are exposed to the magnetic needle and CD34 nanoparticles.
Device: MagProbe (TM)
CD34 nanoparticles incubated in bone marrow and then extracted with the magnetic needle done at time of bone marrow biopsy
Other Name: Magnetic Needle
The ability to reliably detect Minimal Residual Disease (MRD) in leukemia patients allows oncologists to predict patient outcome and to monitor the efficacy of therapy which is critical to improving care. MRD can be used to identify high risk patients who cannot be identified by conventional high risk features, a presence of < 0.1% MRD has been shown to be one of the best predictors of 5-year remission, with 70% of patients with ≥ 0.1% relapsing. In addition to providing predictions of relapse, MRD has been shown to provide a sensitive measure of early treatment response, an independent predictor of good outcome. While the presence of MRD is indicative of patient outcome, the detection of the presence of MRD provides an opportunity to modify treatment and potentially increase survival. Studies are currently underway to use MRD detection in modifying chemotherapeutic treatment and timing of stem cell transplant in leukemia patients. Development of a low cost and easily accessible MRD detector has the potential to expand the number of patients for which MRD testing is available. Expansion of the patient population is a necessary step to large scale testing of MRD detection as both a predictive factor of patient outcome and as a potential modifier of patient treatment. It is expected that increased MRD testing would lead to improved prediction of patient outcomes and increased sensitivity of testing of treatment response. MRD testing in the general patient population could be used to test treatment response and allow oncologists to modify treatment regiments leading to reduced patient mortality and improved medical outcomes.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01411904
|United States, New Mexico|
|University of New Mexico Health Sciences Center|
|Albuquerque, New Mexico, United States, 87131|