We conducted an international phase 2 trial to evaluate 2 dose levels of ofatumumab, a human CD20 mAb, combined with fludarabine and cyclophosphamide (O-FC) as frontline therapy for chronic lymphocytic leukemia (CLL). Patients with active CLL were randomized to ofatumumab 500 mg (n ‫؍‬ 31) or 1000 mg (n ‫؍‬ 30) day 1, with fludarabine 25 mg/m 2 and cyclophosphamide 250 mg/m 2 days 2-4, course 1; days 1-3, courses 2-6; every 4 weeks for 6 courses. The first ofatumumab dose was 300 mg for both cohorts.The median age was 56 years; 13% of patients had a 17p deletion; 64% had ␤2-microglobulin > 3.5 mg/L. Based on the 1996 National Cancer Institute Working Group (NCI-WG) guidelines, the complete response (CR) rate as assessed by an independent review committee was 32% for the 500-mg and 50% for the 1000-mg cohort; the overall response (OR) rate was 77% and 73%, respectively.

No abstract

No abstract

Reference intervals for two well-recognized tests for the lupus anticoagulant were determined using 98 healthy subjects. The purpose of the study was to compare the reference intervals for the dilute tissue thromboplastin inhibition test on this group of healthy subjects calculated by parametric and nonparametric statistical methods, and to compare these results with results obtained on subsets of 20 and 40 randomly selected individuals from the group of 98. The same procedures were followed for the dilute Russell's viper venom test. Results were recorded in seconds of clotting times and in ratios (subject/mean of that set or subset). Statistical analysis revealed Gaussian distribution of the results in the large group as well as in each subset for both tests. The results showed more variation between sets of the dilute tissue thromboplastin inhibition test than of the dilute Russell's viper venom test. Nonparametrically calculated reference intervals were wider than those determined by the parametric method, especially if confidence intervals are provided for both reference limits in a group of 94 controls or in a subset of 40 subjects. The nonparametric technique uses all data for the calculation of reference interval of such sample sizes no matter how widely spread the results are. There was no significant difference between the reference intervals of subsets and the whole group (p > 0.05) calculated by both statistical techniques. Very few outliers were observed among these subjects in both tests.

Objective. The aim of our study was to evaluate the prognostic value of reticulocyte hemoglobin content for diagnosis of iron deficiency in 6-24-month-old children.Material and methods. Children aged 6 to 24 months were consulted for suspected iron deficiency in the outpatient department in 2006-2007. Criteria for inclusion into the study were normal birth time and weight, no infection during the last two weeks before blood sampling (Creactive protein <5 mg/L), no iron supplements 1 month before the study. Red blood cell, reticulocyte indices and biochemical tests were analyzed. A total of 180 children were enrolled in our study. Iron deficiency was diagnosed when at least two of four parameters (ferritin, transferrin, transferrin saturation, and soluble transferrin receptors) reflected iron deficiency.Results. According to our criteria of iron deficiency, patients were divided into two groups: 116 had iron deficiency and 64 had normal iron stores. The iron deficiency group had significantly lower hemoglobin, mean corpuscular hemoglobin, mean corpuscular volume, reticulocyte hemoglobin content, ferritin, soluble transferrin receptors, iron and higher red cell distribution width, transferrin, and transferrin saturation (P<0.05) compared with the normal iron store group. Reticulocyte hemoglobin content, ferritin, and transferrin saturation had the highest sensitivity and specificity (76.6% and 78.4%, 81.3% and 81.9%, 85.9% and 87.9%, respectively).Conclusion. Reticulocyte hemoglobin content is comparable test with ferritin and transferrin saturation and can be used to detect iron deficiency in 6-24-month-old children.