Kinetic Biomarker for Chronic Lymphocytic Leukemia Prognosis (CRC011)
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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 |
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) |
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 |
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
Contacts and 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 | |
| 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 May 23, 2013