Chronic Lymphocytic Leukemia Clinical Trial
Official title:
A CLL Research Consortium (CRC) Phase II Study of Kinetic Biomarker for Chronic Lymphocytic Leukemia (CLL) Prognosis
This project will attempt to validate the utilization of a stable isotope kinetic biomarker (KineMarkerTM) as a predictive test for disease progression in early stage chronic lymphocytic leukemia (CLL).
Chronic Lymphocytic Leukemia (CLL), the most common leukemia in the western world, is
characterized by a pathological expansion of leukemic B cells. The clinical course of CLL is
remarkably heterogeneous; some patients have relatively aggressive disease requiring early
treatment, others have highly indolent disease that does not require current anti-leukemia
therapy until many years after diagnosis. Current staging systems have not been able to
predict which patients in early or intermediate risk stages will undergo disease progression
and which will undergo an indolent course. Universal treatment of all patients with early
stage disease has been shown to be more harmful than beneficial. As such, early
identification of patients who will have more aggressive disease soon after diagnosis has
been a major goal in CLL research.
In response to this need for a reliable prognostic marker, KineMed is investigating the use
of CLL kinetics as a biomarker for subsequent disease progression. This test assesses B-Cell
kinetics directly through an in vivo kinetic measurement of tumor DNA synthesis and
catabolism by combining 2H2O labeling and state of the art analytic instrumentation.
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Observational Model: Cohort
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