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Flavopiridol for Previously Treated Chronic Lymphocytic Leukemia
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Name of the Trial
Phase II Study of Flavopiridol in Patients with Previously Treated B-Cell Chronic
Lymphocytic Leukemia (CLL) or Prolymphocytic Leukemia Arising from CLL (CLLRC-OSU-0491).
See the protocol summary.
This trial previously appeared in the October 25, 2005, issue of the NCI Cancer Bulletin.
Principal Investigator
Dr. John Byrd, Ohio State University and the CLL Research Consortium.
Why This Trial Is Important
Chronic lymphocytic leukemia (CLL) is a blood cancer in which the bone marrow
produces malignant lymphocytes, a type of white blood cell. CLL responds to
standard treatments, such as chemotherapy and monoclonal antibody therapy, but
the disease will recur and eventually become resistant to therapy.
In this trial, researchers are testing a drug called flavopiridol (also known as alvocidib)
in patients with relapsed CLL. Flavopiridol was originally tested in the 1980s,
after laboratory studies showed it had activity against CLL and other types
of cancer cells. In these trials, however, the drug was not effective when given
intravenously over one to three days. Subsequently, interest in it waned.
Recently, Ohio State University (OSU) researchers showed that the effectiveness
of flavopiridol may depend on its route of administration, and a phase I trial
testing a large dose of the drug given over 30 minutes followed by an additional
dose given over four hours has shown promising results in patients with previously
treated CLL. The current phase II trial seeks to confirm these results with
a larger group of patients.
"Approximately 50 percent of patients who had relapsed after multiple
treatments responded to flavopiridol in our study. More importantly, this drug
is highly active in patients with high-risk genetic features, who respond to
few if any standard treatments," said Dr. Thomas Lin of OSU, principal
investigator of the phase I trial.
Who Can Join This Trial
Researchers will enroll 17 to 32 patients aged 18 or over with relapsed B-cell
CLL or a related cancer called prolymphocytic leukemia. See the list
of eligibility criteria.
Study Site and Contact Information
Study sites in the United States are recruiting patients for this trial. See
the list
of study sites or call NCI's Cancer Information Service at 1-800-4-CANCER
(1-800-422-6237). The toll-free call is confidential.
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