7016 Background: In the TRANSCEND-MCL (NCT02631044) primary analysis, the CD19-directed, CAR T cell product liso-cel demonstrated a high, durable CR rate (CRR) with manageable safety in pts with heavily pretreated R/R MCL. Here, we report outcomes by number of prior LOTs and by response to prior BTKi. Methods: Pts had PET-positive R/R MCL after ≥ 2 prior systemic LOTs, including BTKi, alkylating, and CD20-targeted agents. Pts received liso-cel after lymphodepleting chemotherapy. Bridging therapy was allowed. Primary endpoints were treatment-emergent AEs (TEAE) and ORR by independent review committee (IRC) per Lugano 2014 criteria; secondary endpoints included CRR, duration of response (DOR), PFS, and OS. Results: 88 pts received liso-cel. Median follow-up was 16.1 mo (range, 0.4–60.5). For all pts, CRR was 72%; median DOR, PFS, and OS were 15.7, 15.3, and 18.2 mo, respectively (Table). ORR, CRR, and median DOR, PFS, and OS were similar to all pts for most subgroups, but numerically lower in pts with ≥ 5 prior LOTs and pts refractory to prior BTKi. Grade (gr) ≥ 3 TEAEs ranged from 67–96% across subgroups, similar to all pts (86%); most common gr ≥ 3 TEAE was neutropenia (33–58%). Most cytokine release syndrome (CRS) and neurological events (NE) were gr 1–2 (Table) with no gr 5 CRS/NE. Gr ≥ 3 infection (11–19%) and prolonged cytopenia (32–50%) in subgroups were similar to all pts (15% and 40%). Cellular kinetics will be presented. Conclusions: In TRANSCEND-MCL, all subgroups benefited from liso-cel and responses were generally comparable to the overall population, with numerically shorter duration in pts with ≥ 5 prior LOTs and disease refractory to prior BTKi, supporting study of liso-cel in earlier LOTs. Clinical trial information: NCT02631044 . [Table: see text]
Catheter closure of atrial septal defects (ASDs) is an accepted procedure among pediatric cardiologists. We report our early experience with the newest of these devices in clinical trials in the United States. Between April and October 2001, 14 patients were enrolled in an FDA phase II multicenter trial comparing the results of ASD closure using the HELEX Septal Occluder to a surgical control group. Of the 14 patients, devices were placed and left in 13, one being removed for an excessive residual leak despite placing the largest device available. Of the remaining 13 patients, all patients had successful closure of their defects. An average of 1.8 devices/patient were deployed, reflecting the learning curve for this new device and new delivery style. Six devices were replaced because of excessive residual leaks, three for premature lock release, and two for improper seating of the device. There were no procedural complications, however, one patient required device removal 4 months postimplant for possible allergic reaction to nickel. The same patient had removal of stainless steel sternal wires for the same reason. At the 6-month follow-up, 11 of 13 patients had complete closure of the ASD, the other two having small, hemodynamically insignificant left to right shunts. In one of these patients, there was complete closure at the 12-month follow-up, whereas the other patient awaits the 1-year evaluation. Early experience at our institution has demonstrated the ease of use of this device, its complete retrievability, and excellent closure of small to moderate ASDs in children.
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