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Alert Number 140

EGCG: Early Clinical Results in CLL Patients

Date: December 9, 2005

I am happy to report that Project Alpha, the EGCG clinical trial at Mayo Clinic that we sponsored and partially funded, is going well. Recruitment for this novel and low-toxicity approach is progressing at a rapid pace, and this is good news. You can read our latest announcement of this exciting trial by clicking on: Project Alpha Kickoff.

We have also been active introducing patients who write to us with their admittedly anecdotal observations, after taking EGCG as supplements on their own to the Mayo researchers who are interested in studying this green tea component. The paper below has just been published in Leukemia Research. It describes the results seen by four CLL patients who decided to take EGCG supplements. As the paper points out, three of the four patients met the standard definition of partial response! Not bad: this surely beats a kick in the head. We can use a few more such patient friendly and low-toxicity approaches.

Once again, be sure you understand this is anecdotal evidence and therefore of limited value. This is precisely why it is important to do the well controlled clinical trial. I am proud that with the help of our many generous patients and patient families, we were able to sponsor/fund this clinical trial.

Be well,

Chaya
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Leuk Res. 2005 Nov 30;

Clinical effects of oral green tea extracts in four patients with low grade B-cell malignancies

Shanafelt TD, Lee YK, Call TG, Nowakowski GS, Dingli D, Zent CS, Kay NE

Mayo Clinic College of Medicine, Division of Hematology, Mayo Clinic, 200 First Street SW, Rochester, MN

Green tea or its constituents have long been touted as a health promoting substance including claims it may have cancer prevention properties. We previously reported the in vitro ability of one tea polyphenol, epigallocatechin gallate (EGCG), to induce apoptotic cell death in the leukemic B-cells from a majority of patients with chronic lymphocytic leukemia (CLL). After the publication of our findings many patients with CLL and other low grade lymphomas began using over-the-counter products containing tea polyphenols despite the absence of evidence to suggest clinical benefit, definition of possible toxicities, or information on optimal dose and schedule. We have become aware of four patients with low grade B-cell malignancies seen in our clinical practice at Mayo Clinic who began, on their own initiative, oral ingestion of EGCG containing products and subsequently appeared to have an objective clinical response. Three of these four patients met criteria for partial response (PR) by standard response criteria. Although spontaneous remission/regression is occasionally observed in individuals with low grade B-cell malignancies, such events are rare. Several patients presented here had documented steady clinical, laboratory, and/or radiographic evidence of progression immediately prior to initiation of over-the-counter green tea products and then developed objective responses shortly after self-initiating this therapy. Such anecdotes highlight the need for clinical trials of tea polyphenols to define the optimal dosing, schedule, toxicities, and clinical efficacy before widespread use can be recommended. An NCI sponsored phase I/II trial of de-caffeinated green tea extracts for patients with asymptomatic, early stage CLL opened at Mayo Clinic in August 2005.

PMID: 16325256
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