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Kinetic Biomarker for Chronic Lymphocytic Leukemia Prognosis (CRC011)

This study is currently recruiting participants.
Verified by KineMed, April 2008

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

MedlinePlus related topics:   Cancer    Leukemia, Adult Acute    Leukemia, Adult Chronic   

U.S. FDA Resources

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

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

Related Info  This link exits the ClinicalTrials.gov site
 
Related Info  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Responsible Party:   KineMed ( Gregory Hayes, Director - Oncology )
Study ID Numbers:   CRC011, NCI 5R44CA097686-05
First Received:   May 31, 2007
Last Updated:   April 21, 2008
ClinicalTrials.gov Identifier:   NCT00481858
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:
Chronic lymphocytic leukemia
Lymphatic Diseases
Leukemia
Leukemia, Lymphoid
Immunoproliferative Disorders
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoproliferative Disorders
Leukemia, B-Cell

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on September 04, 2008




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