Kinetic Biomarker for Chronic Lymphocytic Leukemia Prognosis

Completed

• Conditions: Chronic Lymphocytic Leukemia

• Registration Number: NCT00481858
• Lead Sponsor: KineMed

Brief 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.

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2007-05-31
• Study First Submitted QC: 2007-05-31
• Study First Posted: 2007-06-04
• Primary Completion: 2010-07
• Study Completion: 2011-01
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-25
• Last Update Posted: 2011-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (5)

UCSD Medical Center; 🇺🇸 San Diego, California, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

North Shore-Long Island Jewish Medical Center; 🇺🇸 New Hyde Park, New York, United States

Ohio State University; 🇺🇸 Columbus, Ohio, United States

M.D. Anderson Cancer Center; 🇺🇸 Houston, Texas, United States