A phase Ib, open label, dose escalation trial of the anti-CD37 monoclonal antibody, BI 836826, in combination with ibrutinib in patients with relapsed/refractory chronic lymphocytic leukemia.

BI 836826 is a chimeric immunoglobulin G1 antibody targeting CD37, a transmembrane protein expressed on normal and malignant B cells. This open-label, phase Ib, dose-escalation study was conducted to determine the recommended phase II dose (RP2D) of BI 836826 + ibrutinib in patients with relapsed/refractory chronic lymphocytic leukemia (CLL). Eligible patients received 420 mg/day of ibrutinib with escalating doses of BI 836826. BI 836826 was administered in 4-week cycles. After Cycle 12, patients achieving complete response (CR), CR with incomplete marrow recovery, or minimal residual disease-negative partial response could continue to receive BI 836826 + ibrutinib every 4 weeks for ≤ 12 additional cycles. Patients received either 100 mg (n = 3) or 200 mg (n = 3) BI 836826 + ibrutinib. In the 100 mg BI 836826 cohort, one patient received two cycles and two patients received 22 cycles of BI 836826. In the 200 mg BI 836826 cohort, patients received 12, 16 and 20 cycles of BI 836826, respectively. All patients discontinued BI 836826 and continued ibrutinib outside the trial. No dose-limiting toxicities were reported in the maximum tolerated dose (MTD) evaluation period. As the trial was discontinued before the MTD was reached, the RP2D was not determined. Grade 3/4 adverse events (AEs) were predominantly hematological. Pseudomonal bacteremia was the only drug-related AE of special interest. BI 836826 + ibrutinib did not exceed the MTD at doses up to 200 mg in patients with CLL. However, RP2D and MTD were not formally established, as the sponsor discontinued the trial.

Views of young, rural African Americans of the role of community social institutions in HIV prevention.

BACKGROUND: We explored rural African American youths' perceptions about the role of community social institutions in addressing HIV. METHODS: We conducted four focus groups with African Americans aged 16 to 24 years in two rural counties in North Carolina. Groups were stratified by gender and risk status. We used a grounded theory approach to content analysis. RESULTS: Participants identified four social institutions as primary providers of HIV-related health promotion efforts: faith organizations, schools, politicians, and health agencies. They reported perceiving a lack of involvement in HIV prevention by faith-based organizations, constraints of abstinence-based sex education policies, politicians' lack of interest in addressing broader HIV determinants, and inadequacies in health agency services, and viewed all of these as being counter-productive to HIV prevention efforts. CONCLUSIONS: Youth have important insights about local social institutions that should be considered when designing HIV prevention interventions that partner with local organizations.

Attractiveness in African American and Caucasian women: is beauty in the eyes of the observer?

Traditional body image studies have been constrained by focusing on body thinness as the sole component of attractiveness. Evidence suggests that African American women may hold a multifactorial view of attractiveness that extends beyond size to include factors such as dress attire and race. The current study employed a culturally sensitive silhouette Model Rating Task (MRT) to examine the effects of attire, body size, and race on attractiveness. Unexpectedly, minimal differences on attractiveness ratings emerged by attire, body size, or model race between African American and Caucasian women. Overall, participants preferred the dressed, underweight, and African American models. Factors such as exposure to diverse groups and changes in African American culture may explain the present findings. Future studies to delineate the components of attractiveness for African American and Caucasian women using the MRT are needed to broaden our understanding and conceptualization of attractiveness across racial groups.