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Kinetic Biomarker for Chronic Lymphocytic Leukemia Prognosis

A CLL Research Consortium (CRC) Phase II Study of Kinetic Biomarker for Chronic Lymphocytic Leukemia (CLL) Prognosis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00481858
Acronym
CRC011
Enrollment
150
Registered
2007-06-04
Start date
2005-07-31
Completion date
2011-01-31
Last updated
2011-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Lymphocytic Leukemia

Keywords

chronic lymphocytic leukemia, biomarker, prognosis, apoptosis, neoplasm/cancer diagnosis, stable isotope, diagnosis evaluation, outcomes, CD19, CD5

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).

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.

Interventions

None listed

Sponsors

Chronic Lymphocytic Leukemia Research Consortium
CollaboratorNETWORK
KineMed
Lead SponsorINDUSTRY

Study design

Observational model
COHORT

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026