At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 73 enrolled
Drug / intervention
Polyphenon Ebiological
Likely dose
Polyphenon E 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I/II Study of Daily Oral Polyphenon E in Asymptomatic, Rai Stage 0-II Patients With Chronic Lymphocytic Leukemia
In Brief
A Phase 2 clinical trial evaluating Polyphenon E for Leukemia. Completed, enrolled 73 participants across 2 sites.
Detailed Summary
RATIONALE: Green tea extract contains ingredients that may slow the growth of certain cancers. PURPOSE: This phase I/II trial is studying the side effects and best dose of green tea extract and to see how well it works in treating patients with stage 0, stage I, or stage II chronic lymphocytic leukemia (CLL).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)
Timeline
Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2005
First PostedDec 2005
Primary CompletionMay 2010
Study CompletionAug 2012
TodayJul 2026
First PostedDec 7, 2005
Enrollment StartAug 1, 2005
Primary CompletionMay 1, 2010
Study CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 20.6 years ago
Interventions
Polyphenon Ebiological
Phase I Dose Escalation:. 400 mg orally twice a day to 2000 mg orally twice a day Phase II: 2000 mg orally twice a day