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Kinetic Biomarker for Chronic Lymphocytic Leukemia Prognosis (CRC011)
This study is currently recruiting participants.
Verified by KineMed, April 2008
First Received: May 31, 2007   Last Updated: April 21, 2008   History of Changes
Sponsors and Collaborators: KineMed
Chronic Lymphocytic Leukemia Research Consortium
Information provided by: KineMed
ClinicalTrials.gov Identifier: NCT00481858
  Purpose

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
Chronic Lymphocytic Leukemia

Study Type: Observational
Study Design: Cohort
Official Title: A CLL Research Consortium (CRC) Phase II Study of Kinetic Biomarker for Chronic Lymphocytic Leukemia (CLL) Prognosis

Resource links provided by NLM:


Further study details as provided by KineMed:

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

CLL cells


Estimated Enrollment: 150
Study Start Date: July 2005
Estimated Study Completion Date: March 2009
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

CLL patients

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00481858

Locations
United States, California
UCSD Medical Center Recruiting
San Diego, California, United States, 92093
Contact: Judith Jones     858-822-6937        
Principal Investigator: Thomas Kipps, M.D., Ph.D.            
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Office Mayo Clinic Cancer Center     507-538-7623        
Principal Investigator: Neil Kay, M.D.            
United States, New York
North Shore-Long Island Jewish Medical Center Recruiting
New Hyde Park, New York, United States, 11040
Contact: Peter Garofalo, R.N., BSN     718-470-4743        
Principal Investigator: Kanti Rai, M.D.            
United States, Ohio
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Pat Curtis, RN     614-293-8607        
Principal Investigator: John Byrd, M.D.            
United States, Texas
M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Chinh Mai     713-563-1383        
Sub-Investigator: Michael Keating, M.B.,B.S.            
Principal Investigator: William G. Wierda, M.D., Ph.D.            
Sub-Investigator: Susan O'Brien, M.D.            
Sponsors and Collaborators
KineMed
Chronic Lymphocytic Leukemia Research Consortium
Investigators
Principal Investigator: Gregory Hayes, Ph.D. KineMed Inc.
  More Information

Additional Information:
Publications:
Responsible Party: KineMed ( Gregory Hayes, Director - Oncology )
Study ID Numbers: CRC011, NCI 5R44CA097686-05
Study First Received: May 31, 2007
Last Updated: April 21, 2008
ClinicalTrials.gov Identifier: NCT00481858     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by KineMed:
chronic lymphocytic leukemia
biomarker
prognosis
apoptosis
neoplasm/cancer diagnosis
stable isotope
diagnosis evaluation
outcomes
CD19
CD5

Study placed in the following topic categories:
Lymphatic Diseases
Leukemia
Chronic Lymphocytic Leukemia
Leukemia, Lymphoid
Immunoproliferative Disorders
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, B-cell, Chronic
Lymphoproliferative Disorders
Leukemia, B-Cell

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

ClinicalTrials.gov processed this record on September 11, 2009