A phase II study of XXXX and rituximab for treatment of newly diagnosed and relapsed/refractory indolent non-Hodgkin lymphoma.

@entity1 @entity137 @entity882 @entity2905 @entity1295 @entity1892 @entity1398 @entity1073 @entity715 @entity782
This study examines the activity and tolerability of a regimen combining @entity782 and rituximab in @entity1 with indolent @entity1892 . A total of 28 @entity1 with newly diagnosed or relapsed/refractory follicular, marginal zone, or @entity1073 , with 4 or less prior therapies were eligible for this open-label phase II study. Oral @entity782 200 mg was administered twice daily on days 1-14 along with 375 mg/m(2) of intravenous rituximab on day 1 of a 21-day cycle, continuing until disease progression or unacceptable @entity137 . Primary end point was objective response rate, with secondary end points of progression-free survival, time to progression, duration of response, safety, and tolerability. Median follow up was 25.6 months and median number of @entity782 cycles was 11.5. Overall response rate was 46% for all @entity1 , 67% for previously untreated, and 41% for relapsed/refractory @entity1 . Median progression-free survival was 29.2 months for all @entity1 , 18.8 months for previously treated @entity1 , and not reached for untreated @entity1 . The regimen was well tolerated over long treatment periods with the most common grade 3/4 adverse events being asymptomatic @entity715 , @entity1398 , @entity882 , @entity2905 , and @entity1295 . The @entity782 /rituximab combination exhibits activity in indolent @entity1892 with an acceptable safety profile and durable responses. Re-treatment was effective in 2 of 3 relapsing responders. This phase II clinical trial was registered at clinicaltrials.gov identifier: 00720876.
