The number of infusion sites and time for infusion was tracked for each patient, as were adverse events. defined by the following criteria [27]: Open in a separate window Fig 1 Study schematic. Diphtheria: 2-fold increase, and must be into protective range (0.1 IU/ml) Tetanus: 2-fold increase, and must be in protective range (0.1 IU/ml) Streptococcus pneumoniae If 1.3 g/ml, 2-fold increase to 1.3 g/ml OR 4-fold increase If 1.3 g/ml, Sagopilone 2-fold increase Responses must be demonstrated by 70% of serotypes Impaired vaccine response is defined at abnormal response to any of the above antigens. Patients with humoral immunodeficiency (as evidenced by an abnormal vaccine response) despite serum IgG 400 mg/dL were offered therapy with 20% liquid SCIG (Hizentra, CSL Behring, King of Prussia, PA) for 24 weeks regardless of infection history. SCIG was given at a fixed dose of 0.13 g/kg/week, and administered every 72 days. Patients did not receive a loading dose of immunoglobulin. Patients were not pre-medicated prior to SCIG therapy unless they experienced infusion-related side effects. Patients received instruction on SCIG administration for 3C4 sessions from a research coordinator, and then transitioned to independent administration at home. The number of infusion sites and time for infusion was tracked for each patient, as were adverse events. SCIG was provided by the sponsor, CSL Behring. The following data was collected for each patient: demographic data (age, race, and gender), time since initial diagnosis of CLL, chemotherapeutic regimen and other therapies used for management of CLL, and number of non-neutropenic infections (NNI) requiring therapy with antibiotics in the previous 6 months (per patient recall in combination with a review of the electronic medical record). All patients underwent a laboratory evaluation for humoral immunodeficiency as defined above. For patients who were treated with SCIG the number of infusion sites and duration of infusion was tracked throughout the study period, as were adverse events. Patients on SCIG completed a quality of life survey (Short Form 36) every 287 days. Ig levels and IgG titers for diphtheria, tetanus, and streptococcus pneumoniae were checked 4, 12, and 24 weeks after starting IgR. A repeat evaluation for humoral immunodeficiency, including pre and post-vaccination IgG titers was completed 3 months after the last dose of SCIG. Statistical analysis Statistical analysis was performed using STATA software (StataCorp LLC, College Station, Texas). Baseline characteristics along with both the primary and secondary endpoints are reported in Sagopilone medians and interquartile (IQR) ranges. A non-parametric, Wilcoxon sign ranked test was used to compare study outcomes at baseline and the completion of the study. Due to the exploratory nature of this proof of concept study, a formal power calculation was not completed prior to study initiation, and the study was not adequately powered to test a specific hypothesis. Microsoft Excel software (Office 365, Sagopilone Microsoft Corporation, Flt1 Redmond, WA 98052) was used to create the figures. Results A total of 18 patients underwent evaluation, with 15 enrolled in the study (Table 1). Three patients were excluded due to IgG 400 mg/dL. There were 13 (86.7%) males and 2 (13.3%) females. The median age of the cohort was 69 years [IQR: 67 to 75]. The median time since diagnosis of CLL was 4.4 years [IQR: 2.6 to 15.2]. The median number of NNI treated with antibiotics was 1 [IQR: 0 to 2]. Previous to enrollment, four patients had undergone treatment regimens for CLL. At the time of the study, one patient was being treated with ibrutinib, while 14 of 15 patients were managed with close observation. Table 1 Demographics. = 7 [IQR:.