Kinetic Biomarker for Chronic Lymphocytic Leukemia Prognosis
CRC011
A CLL Research Consortium (CRC) Phase II Study of Kinetic Biomarker for Chronic Lymphocytic Leukemia (CLL) Prognosis
2 other identifiers
observational
150
1 country
5
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2005
Longer than P75 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
May 31, 2007
CompletedFirst Posted
Study publicly available on registry
June 4, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedFebruary 28, 2011
February 1, 2011
5 years
May 31, 2007
February 25, 2011
Conditions
Keywords
Eligibility Criteria
CLL patients
You may qualify if:
- \>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
You may not qualify if:
- current or prior cll treatment
- serious co-morbid medical condition
- patient likely to need treatment in the next 16 weeks
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- KineMedlead
- Chronic Lymphocytic Leukemia Research Consortiumcollaborator
Study Sites (5)
UCSD Medical Center
San Diego, California, 92093, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
North Shore-Long Island Jewish Medical Center
New Hyde Park, New York, 11040, United States
Ohio State University
Columbus, Ohio, 43210, United States
M.D. Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (2)
Messmer BT, Messmer D, Allen SL, Kolitz JE, Kudalkar P, Cesar D, Murphy EJ, Koduru P, Ferrarini M, Zupo S, Cutrona G, Damle RN, Wasil T, Rai KR, Hellerstein MK, Chiorazzi N. In vivo measurements document the dynamic cellular kinetics of chronic lymphocytic leukemia B cells. J Clin Invest. 2005 Mar;115(3):755-64. doi: 10.1172/JCI23409.
PMID: 15711642RESULTHayes GM, Busch R, Voogt J, Siah IM, Gee TA, Hellerstein MK, Chiorazzi N, Rai KR, Murphy EJ. Isolation of malignant B cells from patients with chronic lymphocytic leukemia (CLL) for analysis of cell proliferation: validation of a simplified method suitable for multi-center clinical studies. Leuk Res. 2010 Jun;34(6):809-15. doi: 10.1016/j.leukres.2009.09.032. Epub 2009 Oct 24.
PMID: 19854509DERIVED
Related Links
Biospecimen
CLL cells
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gregory Hayes, Ph.D.
KineMed Inc.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 31, 2007
First Posted
June 4, 2007
Study Start
July 1, 2005
Primary Completion
July 1, 2010
Study Completion
January 1, 2011
Last Updated
February 28, 2011
Record last verified: 2011-02