Clinical Trials

Kinetic Biomarker for Chronic Lymphocytic Leukemia Prognosis

Location:

Trial status:

Closed

Why is this study being done?

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.

Who is eligible to participate?

Inclusion Criteria:

- >18 years of age

- clinical diagnosis of chronic lymphocytic leukemia

- diagnosis within previous 3 years

- Stage 0, I, or II disease

- willingness and capacity to give informed consent

Exclusion Criteria:

- current or prior cll treatment

- serious co-morbid medical condition

- patient likely to need treatment in the next 16 weeks

- pregnancy

Last updated: 02/25/2011

NCT ID:

NCT00481858