Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
KineMed Chronic Lymphocytic Leukemia Research Consortium |
---|---|
Information provided by: | KineMed |
ClinicalTrials.gov Identifier: | NCT00481858 |
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 |
CLL cells
Estimated Enrollment: | 150 |
Study Start Date: | July 2005 |
Estimated Study Completion Date: | March 2009 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
CLL patients
Inclusion Criteria:
Exclusion Criteria:
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. |
Principal Investigator: | Gregory Hayes, Ph.D. | KineMed Inc. |
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 |
Health Authority: | United States: Institutional Review Board |
chronic lymphocytic leukemia biomarker prognosis apoptosis neoplasm/cancer diagnosis |
stable isotope diagnosis evaluation outcomes CD19 CD5 |
Chronic lymphocytic leukemia Lymphatic Diseases Leukemia Leukemia, Lymphoid Immunoproliferative Disorders |
Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, B-cell, chronic Lymphoproliferative Disorders Leukemia, B-Cell |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |