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Regulatory T cells (Tregs) are considered to be key immunomodulatory cells of the immune system and are increased in chronic lymphocytic leukemia (CLL). Rai stage 0 identifies patients with early stage CLL for which there is no effective intervention at the present time and a "wait and see" policy is usually adopted. Some biological and clinical studies have reported that green tea constituents, such as epigallocatechin-gallate (EGCG), have antitumor effects on hematologic malignancies including CLL. We report data on a clinical trial in which green tea extracts were given orally to 12 patients with stage 0 CLL and 12 healthy subjects. Ten patients and 10 controls completed the 6-month scheduled therapy. Two patients and 2 controls stopped therapy within 1 month because of tachycardia and epigastralgia. Eight out 10 evaluable patients (80 percent) showed a reduction of lymphocytosis and absolute number of circulating Tregs, as well. One patient (10 percent) had a stabilization of lymphocytosis and a reduction of Tregs, and 1 patient (10 percent) showed an increase of both lymphocytosis and Tregs. Only the non-responding patient progressed after 5 months from the end of green tea administration and chemotherapy was given. Interestingly, both IL-10 and TGF-beta serum levels declined throughout the green tea intake period, in both patients and controls. These data seem to indicate that green tea is able to modulate circulating Tregs in CLL patients with early stage of the disease. This can result in the control of lymphocytosis as well as in the prevention of disease progression.

HPLC analyses of dry extracts obtained from Passiflora incarnata revealed the presence of ten known flavonoids whose structures were characterised by ionspray ionization tandem mass spectrometry; in addition, three unidentified peaks, F 1, F2, and F3 appeared in the flavonoid region of the chromatogram. Two components were detected in F3 by on-line HPLC-ISI-MS analysis, named F3a and F3b. F2 was demonstrated to be a structural isomer of schaftoside (I), and F3a of isoschaftoside (2), with apigenin as the common aglycone and molecular weight 564. Mass spectra and 2D-NMR experiments allowed us to assign the structure of 6-~-D-glucopyranosyl-8-~-D-ribopyranosyl apigenin to the new di-C-glycosylflavonoid F2.

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