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Abstract
Poly-[1–6]-β-glucopyranosyl-[1–3]-β-glucopyranose (PGG) beta glucan is a Saccharomyces cerevisiae derived 1,3/1,6 glucose polymer with innate immune system activation potential. This phase I/II clinical trial enrolled 20 eligible patients with chronic lymphocytic leukemia with high-risk biological markers for early initial treatment with alemtuzumab, rituximab and PGG beta glucan (1–2–4 mg/kg/dose) over 31 days. PGG beta glucan at 4 mg/kg was well tolerated and used for the phase II study. There were three grade 3–4 toxicities at least possibly attributed to treatment. Nineteen (95%) patients responded to treatment with 13 (65%) complete responses. All patients were alive at a median follow-up of 24.4 months (range: 9.5–37). Eleven patients had progressive disease (median 17.6 months, 95% confidence interval [CI]: 9.7, 32.1) and eight patients were retreated (median 35.3 months, 95% CI: 17.9, not reached). We conclude that PGG beta glucan, alemtuzumab and rituximab treatment is tolerable and results in a high complete response rate.
Acknowledgement
This study was funded by the University of Iowa/Mayo Clinic Lymphoma SPORE (CA097274), The Gateway for Cancer Research and Biothera.
Potential conflict of interest
Disclosure forms provided by the authors are available with the full text of this article at www.informahealthcare.com/lal.