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

18 Years
Not Enrolling
Chronic Lymphocytic Leukemia

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Trial Information

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

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.

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

Type of Study:


Study Design:

Observational Model: Cohort

Principal Investigator

Gregory Hayes, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

KineMed Inc.


United States: Institutional Review Board

Study ID:




Start Date:

July 2005

Completion Date:

January 2011

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • chronic lymphocytic leukemia
  • biomarker
  • prognosis
  • apoptosis
  • neoplasm/cancer diagnosis
  • stable isotope
  • diagnosis evaluation
  • outcomes
  • CD19
  • CD5
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid



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Ohio State UniversityColumbus, Ohio  43210
M.D. Anderson Cancer CenterHouston, Texas  77030
UCSD Medical CenterLa Jolla, California  92093
North Shore-Long Island Jewish Medical CenterNew Hyde Park, New York  11040