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Kinetic Biomarker for Chronic Lymphocytic Leukemia Prognosis (CRC011)

K

KineMed

Status

Completed

Conditions

Chronic Lymphocytic Leukemia

Study type

Observational

Funder types

NETWORK
Industry

Identifiers

NCT00481858
NCI 5R44CA097686-05
CRC011

Details and patient eligibility

About

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).

Full 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.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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