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Lenalidomide safe as single therapy for
Elderly CLL Patients
Newswise — The oral medication lenalidomide is safe and
well-tolerated for elderly patients with
chronic lymphocytic leukemia, a group
without a well-defined frontline therapy for
their disease, researchers from The
University of Texas M. D. Anderson Cancer
Center reported today at the 50th annual
meeting of the American Society of
Hematology.
“Lenalidomide has a favorable toxicity profile and shows
signs of activity against CLL in our phase
II clinical trial to date,” said study
presenter Alessandra Ferrajoli, M.D.,
associate professor in M. D. Anderson’s
Department of Leukemia.
Patients start on a 5 mg dose of the drug in pill form and
the dose escalates over time in 5 mg
increments to a maximum of 25 mg. The median
age of participants is 72.
Chemo-immunotherapy therapy combinations that are effective
in younger patients with CLL tend to be
associated with a high rate of complications
in patients older than 70, Ferrajoli said.
Of 43 patients enrolled in the study, 35 were evaluable
because they had been treated for at least
three months.
Nineteen of these (54 percent) achieved a partial response,
where the disease is diminished, 14 patients
(40 percent) had stable disease and continue
on therapy, and two had their CLL progress.
Lenalidomide also rapidly reduced the number of circulating
lymphocytes – the hallmark of the disease –
in the patients’ blood.
Ferrajoli said 47 percent achieved a blood complete
response and 38 percent had at least a
partial response.
Patients on the trial for at least two months were
evaluated for the drug’s potential side
effects. Of those 39 patients, 10 (26
percent) had decreased bone marrow activity
resulting in a decrease in the number of
either white blood cells called neutrophils
or of platelets.
Three patients had infections, two had fever and one had
pneumonia.
All patients registered in the study remain alive with 37
of the 43 continuing on treatment. Ferrajoli
said the trial will include up to 60
patients.
Lenalidomide, a drug developed by Celgene Corp. known
commercially as Revlimid®, attacks both
malignant cells and the cellular environment
that nurtures them.
The U.S. Food and Drug Administration has approved the drug
for treatment of multiple myeloma and some
forms of myelodysplastic syndrome.
The clinical trial is funded by Celgene.
Co-authors with Ferrajoli are Susan O’Brien, M.D., William
Wierda, M.D., Ph.D., Stefan Faderl, M.D.,
Zeev Estrov, M.D., Kimberly Yerrow, R.N.,
Hagop Kantarjian, M.D., and Michael Keating,
M.D., all of the Department of Leukemia; and
Steven Kornblau, M.D. of the Department of
Stem Cell Transplantation and Cellular
Therapy and the Department of Leukemia.
Ferrajoli has received honoraria and research funding from
Celgene. O’Brien and Keating have consulted
for Celgene.
About M. D. Anderson
The University of Texas M. D. Anderson
Cancer Center in Houston ranks as one of the
world’s most respected centers focused on
cancer patient care, research, education and
prevention.
M. D. Anderson is one of only 41 Comprehensive Cancer
Centers designated by the National Cancer
Institute. For six of the past nine years,
M. D. Anderson has ranked No. 1 in cancer
care in “America's Best Hospitals,” a survey
published annually in U.S. News and World
Report.
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