ABSTRACT
This phase II clinical trial investigates a one-time oromucosal dose of tetrahydrocannabinol/cannabidiol (THC/CBD) in 23 patients with indolent leukemic B cell lymphomas. Primary endpoint
was a significant reduction in leukemic B cells. Grade 1 2 adverse events were seen in 91% of
the patients; most common were dry mouth (78%), vertigo (70%), and somnolence (43%). After
THC/CBD a significant reduction in leukemic B cells (median, 11%) occurred within two hours
(p ¼ .014), and remained for 6 h without induction of apoptosis or proliferation. Normal B cells
and T cells were also reduced. CXCR4 expression increased on leukemic cells and T cells. All
effects were gone by 24 h. Our results show that a single dose of THC/CBD affects a wide variety
of leukocytes and only transiently reduce malignant cells in blood. Based on this study, THC/
CBD shows no therapeutic potential for indolent B cell lymphomas (EudraCT trial no. 2014-
005553-39)
