CRC011: Kinetic Biomarker for Chronic Lymphocytic Leukemia Prognosis

Sponsor

KineMed (Industry)

Overall Status

Completed

CT.gov ID

NCT00481858

Collaborator

Chronic Lymphocytic Leukemia Research Consortium (Other)

150

Enrollment

Locations

Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Chronic Lymphocytic Leukemia

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 Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Cohort

Official Title:

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

Study Start Date :

Jul 1, 2005

Actual Primary Completion Date :

Jul 1, 2010

Actual Study Completion Date :

Jan 1, 2011

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCSD Medical Center	San Diego	California	United States	92093
2	Mayo Clinic	Rochester	Minnesota	United States	55905
3	North Shore-Long Island Jewish Medical Center	New Hyde Park	New York	United States	11040
4	Ohio State University	Columbus	Ohio	United States	43210
5	M.D. Anderson Cancer Center	Houston	Texas	United States	77030