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Completed

NCT Number: NCT00481858

Kinetic Biomarker for Chronic Lymphocytic Leukemia Prognosis

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).

Completed

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

KineMed

Industry

Collaborators

  • Chronic Lymphocytic Leukemia Research Consortium

Registry information

Official study title

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

Acronym: CRC011

Important dates

Study start
2005
Primary completion
2010
Study completion
2011
First posted
Jun 4, 2007
Registry last updated
Feb 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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