Kinetic Biomarker for Chronic Lymphocytic Leukemia Prognosis (CRC011)

This study has been completed.
Sponsor:
Collaborator:
Chronic Lymphocytic Leukemia Research Consortium
Information provided by:
KineMed
ClinicalTrials.gov Identifier:
NCT00481858
First received: May 31, 2007
Last updated: February 25, 2011
Last verified: February 2011
  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: Observational Model: 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

CLL cells


Estimated Enrollment: 150
Study Start Date: July 2005
Study Completion Date: January 2011
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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
KineMed
Chronic Lymphocytic Leukemia Research Consortium
Investigators
Principal Investigator: Gregory Hayes, Ph.D. KineMed Inc.
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gregory Hayes, Director - Oncology, KineMed
ClinicalTrials.gov Identifier: NCT00481858     History of Changes
Other Study ID Numbers: CRC011, NCI 5R44CA097686-05
Study First Received: May 31, 2007
Last Updated: February 25, 2011
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

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

ClinicalTrials.gov processed this record on July 23, 2014