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Phase 1
Open (Enrolling by invite only)

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Trial Information

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.

Group: Leukemia Patients

Inclusion Criteria:

- Suspected diagnosis of Leukemia

- Requiring bone marrow biopsy for standard care

Exclusion Criteria:

- unable to consent for entrance into the study

Group: Non-leukemia Patients

Inclusion Criteria:

- Requiring bone marrow biopsy for standard care

Exclusion Criteria:

- unable to consent for entrance into the study

- Leukemia diagnosis

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Lymphoblast percent

Outcome Description:

Lymphoblast percent calculated before exposure to needle and of the needle enhanced sample

Outcome Time Frame:

1 day

Safety Issue:



United States: Federal Government

Study ID:




Start Date:

August 2010

Completion Date:

January 2013

Related Keywords:

  • Leukemia
  • Leukemia
  • magnetic needle
  • magnetic nanoparticles
  • CD34
  • Leukemia



University of New Mexico Health Sciences CenterAlbuquerque, New Mexico  87131