Phase I trial of daily oral Polyphenon E in patients with asymptomatic Rai stage 0 to II chronic lymphocytic leukemia.

ABSTRACT:

Purpose

To define the optimal dose of Polyphenon E for chronic daily administration and tolerability in patients with chronic lymphocytic leukemia (CLL).

Patients and methods

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.

Results

Thirty-three eligible patients were accrued to dose levels 1 to 8. The maximum-tolerated dose was not rea

SUBMITTER: Shanafelt TD 

PROVIDER: S-EPMC2727287 | biostudies-literature | 2009 Aug

REPOSITORIES: biostudies-literature