Kinetic Biomarker for Chronic Lymphocytic Leukemia Prognosis

Chronic Lymphocytic Leukemia Clinical Trial

— CRC011  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00481858
• Other study ID #: CRC011
• Secondary ID: NCI 5R44CA097686
• Status: Completed
• Phase: N/A
• First received: May 31, 2007
• Last updated: February 25, 2011
• Start date: July 2005
• Est. completion date: January 2011

Study information

• Verified date: February 2011
• Source: KineMed
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 2011
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Locations

Country	Name	City	State
United States	Ohio State University	Columbus	Ohio
United States	M.D. Anderson Cancer Center	Houston	Texas
United States	North Shore-Long Island Jewish Medical Center	New Hyde Park	New York
United States	Mayo Clinic	Rochester	Minnesota
United States	UCSD Medical Center	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
KineMed	Chronic Lymphocytic Leukemia Research Consortium

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 lymphocyti — View Citation

External Links

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