Phase II study of bendamustine combined with rituximab in relapsed/refractory mantle cell lymphoma: efficacy, tolerability, and safety findings.

In most cases of relapsed/refractory mantle cell lymphoma (MCL), patients respond to salvage therapy, though typically responses are partial and/or transient followed by disease progression, even with newer agents (e.g., ibrutinib). In this multicenter, open-label, single-arm, phase II study, patients with relapsed/refractory non-blastoid MCL received bendamustine 90 mg/m(2) (days 1 and 2) and rituximab 375 mg/m(2) (day 1) for 6 planned 28-day cycles. Functional imaging with 18-fluoro-2-deoxy-D-glucose positron emission tomography/computed tomography (18F-FDG PET/CT) was conducted at baseline and after cycle 6. Forty-five patients were enrolled (median age, 70 years; 82 % stage IV disease; median number of prior chemotherapies, 2 [range, 1-4]), showing an overall response rate (ORR; primary efficacy measure) of 82 % (complete response [CR], 40 %; partial response, 42 %). In the 32 patients with complete 18F-FDG PET/CT data, 75 % achieved a complete metabolic response. Median duration of response was 1.6 years, 1-year progression-free survival was 67 %, and 3-year overall survival was 55 %. Main non-hematologic adverse events were nausea (69 %), fatigue (56 %), decreased appetite (42 %), constipation (38 %), diarrhea (36 %), vomiting (36 %), and decreased weight (31 %). Grade 3/4 neutropenia and lymphopenia occurred in 44 and 89 % of patients, respectively. ORR and CR rate compared favorably with single-agent ibrutinib (ORR, 67 %; CR, 23 %); bendamustine-rituximab is an effective therapy with manageable toxicity in relapsed/refractory MCL.

A device to record ultra-rapid cooling profiles.

This work deals with the construction and performance of a measuring system capable of estimating temperature at sufficiently high speed (up to 1000 samples per sec). Due to its simple design and the utilization of standard materials, it could serve to recording the cooling profile of ultra-rapid procedures. An immersion device was also developed with the purpose of normalize the penetration speed of the sample in the LN2. The device allows also the comparative analysis of different cooling profiles. The system consists of an immersion device of the sample in the cooling agent, a temperature measurement system developed by Kleihans F and a laptop computer. To test the system, we recorded the cooling profiles of 10 uL of distilled water and 6 M glycerol solution, obtaining a cooling rate of 8732 C/min and 4441 C/min respectively. Also we determine a cooling rate of 204.012 C/min during the immersion of the thermocouple assembly in LN2. Although, the same device, with small technical modifications related to the handling of the sample, could be used to evaluate the recovery from LN2 temperature to room temperature (re-warming).