Friday, June 5, 2009
FRIDAY, June 5 (HealthDay News) -- An oral preparation of epigallocatechin-3-gallate (EGCG) with Polyphenon E appeared to be well tolerated and provided clinical activity in patients with chronic lymphocytic leukemia (CLL), according to research published online May 26 in the Journal of Clinical Oncology.
Tait D. Shanafelt, M.D., of the Mayo Clinic in Rochester, Minn., and colleagues analyzed data from a Phase I trial involving 33 patients with Rai stage 0 to II CLL given varying doses of Polyphenon E capsules, containing EGCG.
The researchers found that the treatment appeared to be well tolerated, with common side effects including transaminitis (in 11 patients, all grade 1), abdominal pain (grade 1 in 10 patients and grade 3 in one patient) and nausea (grade 1 in 13 patients and grade 2 in three patients). One patient showed a partial remission, 11 patients had at least a 20 percent sustained reduction in absolute lymphocyte count, and overall, 18 patients fulfilled the criteria for a biologic response.
"Despite extensive data demonstrating that 50 to 70 percent of patients with asymptomatic, earlier stage CLL will progress and require treatment, such patients are presently managed with observation. The phase I data presented here suggest that Polyphenon E may have clinical activity in these patients and the fact that this treatment is very well tolerated suggests Polyphenon E merits additional evaluation as a disease stabilizing agent," the authors conclude.
Polyphenon E International provided support for the study.
Diabetes & Endocrinology
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