Clinical trial NCT00481858: Kinetic Biomarker for Chronic Lymphocytic Leukemia Prognosis
Official title: A CLL Research Consortium (CRC) Phase II Study of Kinetic Biomarker for Chronic Lymphocytic Leukemia (CLL) Prognosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Lymphocytic Leukemia
Keywords: chronic lymphocytic leukemia
biomarker
prognosis
apoptosis
neoplasm/cancer diagnosis
stable isotope
diagnosis evaluation
outcomes
CD19
CD5
Lead sponsor: KineMed
Sponsor class: INDUSTRY
Collaborators: name: Chronic Lymphocytic Leukemia Research Consortium
First posted: 2007-06-04
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CLL patients

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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UCSD Medical Center
state: California
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New Hyde Park
country: United States
facility: North Shore-Long Island Jewish Medical Center
state: New York
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Houston
country: United States
facility: M.D. Anderson Cancer Center
state: Texas
Study officials:
affiliation: KineMed Inc.
name: Gregory Hayes, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Messmer BT, Messmer D, Allen SL, Kolitz JE, Kudalkar P, Cesar D, Murphy EJ, Koduru P, Ferrarini M, Zupo S, Cutrona G, Damle RN, Wasil T, Rai KR, Hellerstein MK, Chiorazzi N. In vivo measurements document the dynamic cellular kinetics of chronic lymphocytic leukemia B cells. J Clin Invest. 2005 Mar;115(3):755-64. doi: 10.1172/JCI23409.
citation: Hayes GM, Busch R, Voogt J, Siah IM, Gee TA, Hellerstein MK, Chiorazzi N, Rai KR, Murphy EJ. Isolation of malignant B cells from patients with chronic lymphocytic leukemia (CLL) for analysis of cell proliferation: validation of a simplified method suitable for multi-center clinical studies. Leuk Res. 2010 Jun;34(6):809-15. doi: 10.1016/j.leukres.2009.09.032. Epub 2009 Oct 24.