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This phase I/II clinical trial enrolled 20 eligible CLL patients 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.
Patients in treatment groups were administered PGG glucan at a dose of 0.5 mg/kg or 1.0 mg/kg preoperatively and three times postoperatively. Results showed that there was no difference in severe infections and mortality between treatment and placebo groups.
16 lis 2012 · The starting dose level of PGG beta glucan was 1 mg/kg, 2 nd dose level was 2 mg/kg and the 3 rd dose level 4 mg/kg. Subcutaneous ALM therapy started on day 3 with daily dose escalation (3 – 10 – 30 mg) and then 30 mg Mon-Wed-Friday for 4 weeks.
1 sty 2009 · The ability of a single 2-mg/kg dose of PGG-Glucan to mobilize GM-CFC into the peripheral circulation of mice is illustrated in Figure 1. Peak mobilization occurred within 30 min of PGG-Glucan administration, at which time approximately a fourfold increase in GM-CFC numbers was observed.
25 paź 2005 · Three groups, each with six individuals, received either 100 mg/day (group 1), 200 mg/day (group 2) or 400 mg/day (group 3). Selection of dose range was based on previous experience with β-glucans in animal models [12] and humans [13, 29].
1 maj 2021 · A randomized, open-label, multicenter, phase II study evaluating the efficacy and safety of BTH1677 (1,3–1,6 beta glucan; Imprime PGG) in combination with cetuximab and chemotherapy in patients with advanced non-small cell lung cancer
The starting dose (dose level 0) in the phase I study was 1 mg/kg, dose level 1 was 2mg/kg/dose and dose level 2 was 4 mg/kg/dose. For the first dose of PGG beta glucan patients were premedicated with 1000 mg acetaminophen by mouth (po), 50 mg diphenhydramine po, and 100 mg hydrocortisone IV.