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Chronic Lymphocytic LeukemiaCRC011NCT00481858

Kinetic Biomarker for Chronic Lymphocytic Leukemia Prognosis

An observational study of Chronic Lymphocytic Leukemia, run by KineMed at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Lymphocytic Leukemia
How many people
150 participants
Where
5 sitesUnited States
Study dates
Jul 2005to Jan 2011
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: CLL patients

Who may be able to join

  • >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

Who cannot join

  • current or prior cll treatment
  • serious co-morbid medical condition
  • patient likely to need treatment in the next 16 weeks
  • pregnancy

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Ohio State University

    Columbus, Ohio, 43210

  • M.D. Anderson Cancer Center

    Houston, Texas, 77030

  • North Shore-Long Island Jewish Medical Center

    New Hyde Park, New York, 11040

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • UCSD Medical Center

    San Diego, California, 92093

Other trials in United States

About this study

Official title: A CLL Research Consortium (CRC) Phase II Study of Kinetic Biomarker for Chronic Lymphocytic Leukemia (CLL) 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).

Read the 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.

Keywords
chronic lymphocytic leukemia, biomarker, prognosis, apoptosis, neoplasm/cancer diagnosis, stable isotope, diagnosis evaluation, outcomes, CD19, CD5
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell, Neoplasms

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2007 (estimated)
  2. Study startJul 2005
  3. Primary completionJul 2010
  4. Study completionJan 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00481858
Sponsor's protocol ID
CRC011
Other IDs
NCI 5R44CA097686-05
Acronym
CRC011
Status last verified
Feb 2011
First submitted
31 May 2007
Last updated
28 Feb 2011
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 15711642

  • Hayes 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.

    PubMed 19854509

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Lymphocytic Leukemia, run by KineMed at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00481858, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2011.

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