Kinetic Biomarker for Chronic Lymphocytic Leukemia Prognosis (CRC011)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00481858
Recruitment Status : Completed
First Posted : June 4, 2007
Last Update Posted : February 28, 2011
Chronic Lymphocytic Leukemia Research Consortium
Information provided by:

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
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 Type : Observational
Estimated 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 : July 2005
Actual Primary Completion Date : July 2010
Actual Study Completion Date : January 2011

Biospecimen Retention:   Samples With DNA
CLL cells

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
CLL patients

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00481858

United States, California
UCSD Medical Center
San Diego, California, United States, 92093
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
North Shore-Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
United States, Texas
M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Chronic Lymphocytic Leukemia Research Consortium
Principal Investigator: Gregory Hayes, Ph.D. KineMed Inc.

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Gregory Hayes, Director - Oncology, KineMed Identifier: NCT00481858     History of Changes
Other Study ID Numbers: CRC011
NCI 5R44CA097686-05
First Posted: June 4, 2007    Key Record Dates
Last Update Posted: February 28, 2011
Last Verified: February 2011

Keywords provided by KineMed:
chronic lymphocytic leukemia
neoplasm/cancer diagnosis
stable isotope
diagnosis evaluation

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell