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Kinetic Biomarker for Chronic Lymphocytic Leukemia Prognosis

NCT ID: NCT00481858

Last Updated: 2011-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-07-31

Study Completion Date

2011-01-31

Brief Summary

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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

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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

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Chronic Lymphocytic Leukemia

Keywords

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chronic lymphocytic leukemia biomarker prognosis apoptosis neoplasm/cancer diagnosis stable isotope diagnosis evaluation outcomes CD19 CD5

Study Design

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Observational Model Type

COHORT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chronic Lymphocytic Leukemia Research Consortium

NETWORK

Sponsor Role collaborator

KineMed

INDUSTRY

Sponsor Role lead

Responsible Party

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KineMed

Principal Investigators

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Gregory Hayes, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

KineMed Inc.

Locations

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UCSD Medical Center

San Diego, California, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

North Shore-Long Island Jewish Medical Center

New Hyde Park, New York, United States

Site Status

Ohio State University

Columbus, Ohio, United States

Site Status

M.D. Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 15711642 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19854509 (View on PubMed)

Related Links

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http://www.kinemed.com

Related Info

Other Identifiers

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NCI 5R44CA097686-05

Identifier Type: -

Identifier Source: secondary_id

CRC011

Identifier Type: -

Identifier Source: org_study_id