title: Early treatment of high risk chronic lymphocytic leukemia with alemtuzumab, rituximab and poly-(1-6)-beta-glucotriosyl-(1-3)- beta-glucopyranose beta-glucan is well tolerated and achieves high complete remission rates.
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.
authors: a Division of Hematology.
authors: Clive S
authors: CS
authors: Zent
authors: a Division of Hematology.
authors: Timothy G
authors: TG
authors: Call
authors: a Division of Hematology.
authors: Deborah A
authors: DA
authors: Bowen
authors: a Division of Hematology.
authors: Michael J
authors: MJ
authors: Conte
authors: b Department of Health Sciences Research , Mayo Clinic , Rochester , MN , USA.
authors: Betsy R
authors: BR
authors: LaPlant
authors: a Division of Hematology.
authors: Thomas E
authors: TE
authors: Witzig
authors: a Division of Hematology.
authors: Stephen M
authors: SM
authors: Ansell
authors: c Holden Comprehensive Cancer Center and Department of Internal Medicine , University of Iowa , Iowa City , IA , USA.
authors: George J
authors: GJ
authors: Weiner
mesh_terms: D000368:Aged; D000074323:Alemtuzumab; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D014408:Biomarkers, Tumor; D002869:Chromosome Aberrations; D018450:Disease Progression; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D015451:Leukemia, Lymphocytic, Chronic, B-Cell / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D012074:Remission Induction; D000069283:Rituximab / Q000008:administration & dosage; D016896:Treatment Outcome; D047071:beta-Glucans / Q000008:administration & dosage
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D014408:Biomarkers, Tumor; D047071:beta-Glucans; D000074323:Alemtuzumab; D000069283:Rituximab
keywords: CLL; Chronic lymphocytic leukemia/small lymphocytic lymphoma; PGG beta glucan; alemtuzumab; high risk; rituximab