NCT00481858

Kinetic Biomarker for Chronic Lymphocytic Leukemia Prognosis

A CLL Research Consortium (CRC) Phase II Study of Kinetic Biomarker for Chronic Lymphocytic Leukemia (CLL) Prognosis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: KineMed · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Chronic Lymphocytic Leukemia

Timeline

• Start date: 2005-07-01
• Primary completion: 2010-07-01
• Completion: 2011-01-01
• First posted: 2007-06-04
• Last updated: 2011-02-28

Locations

5 sites across 1 country: United States