{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,26]],"date-time":"2026-09-26T06:18:41Z","timestamp":1790403521105,"version":"4.1.0"},"reference-count":53,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"23","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCO"],"published-print":{"date-parts":[[2009,8,10]]},"abstract":"<jats:sec><jats:title>Purpose<\/jats:title><jats:p> To define the optimal dose of Polyphenon E for chronic daily administration and tolerability in patients with chronic lymphocytic leukemia (CLL). <\/jats:p><\/jats:sec><jats:sec><jats:title>Patients and Methods<\/jats:title><jats:p> Previously untreated patients with asymptomatic Rai stage 0 to II CLL were eligible for participation. Polyphenon E with a standardized dose of epigallocatechin-3-gallate (EGCG) was administered using the standard phase I design with three to six patients per dose level (range, 400 to 2,000 mg by mouth twice a day). Trough plasma EGCG levels were measured 1 month after initiation of therapy. Response was classified using the National Cancer Institute (NCI) Working Group (WG) Criteria. <\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p> Thirty-three eligible patients were accrued to dose levels 1 to 8. The maximum-tolerated dose was not reached. The most common adverse effects included transaminitis (33%, all grade 1), abdominal pain (30% grade 1, 0% grade 2, and 3% grade 3), and nausea (39% grade 1 and 9% grade 2). One patient experienced an NCI WG partial remission. Other signs of clinical activity were also observed, with 11 patients (33%) having a sustained \u2265 20% reduction in absolute lymphocyte count (ALC) and 11 (92%) of 12 patients with palpable adenopathy experiencing at least a 50% reduction in the sum of the products of all nodal areas during treatment. Trough plasma EGCG levels after 1 month of treatment ranged from 2.9 to 3,974 ng\/mL (median, 40.4 ng\/mL). <\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p> Daily oral EGCG in the Polyphenon E preparation was well tolerated by CLL patients in this phase I trial. Declines in ALC and\/or lymphadenopathy were observed in the majority of patients. A phase II trial to evaluate efficacy using 2,000 mg twice a day began in November 2007. <\/jats:p><\/jats:sec>","DOI":"10.1200\/jco.2008.21.1284","type":"journal-article","created":{"date-parts":[[2009,5,27]],"date-time":"2009-05-27T02:30:33Z","timestamp":1243391433000},"page":"3808-3814","source":"Crossref","is-referenced-by-count":143,"title":["Phase I Trial of Daily Oral Polyphenon E in Patients With Asymptomatic Rai Stage 0 to II Chronic Lymphocytic Leukemia"],"prefix":"10.1200","volume":"27","author":[{"given":"Tait D.","family":"Shanafelt","sequence":"first","affiliation":[{"name":"From the Department of Internal Medicine, Division of Hematology; Division of Biostatistics, and Departments of Immunology and Oncology, Mayo Clinical, Rochester, MN; and the Department of Chemical Biology, and the Ernest Mario School of Pharmacy Rutgers, the State University of New Jersey, Piscataway, NJ."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tim 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