UNASSIGNED: 8030 Background: @entity6985 has been shown to have single-agent activity in relapsed @entity1893 , and rituximab (R) is effective alone and in combination with chemotherapy in untreated @entity1 . The aim of this phase II, single arm study is to evaluate the efficacy and safety of @entity6985 and rituximab in pts with untreated, advanced stage, indolent @entity1893 . METHODS: Pts with measurable (>1.5 cm) untreated indolent @entity1893 received 20 mg/day of @entity6985 on days 1-21 and rituximab 375 mg/m(2) on day 1 of each 28 day cycle. Prophylactic growth factors were not used. Response was assessed every 3 cycles using the 1999 International Working Group Response Criteria. RESULTS: 75 pts have completed 6 cycles of treatment or are off-study, and 70 pts are evaluable for response. Histologies included: @entity1072 /SLL n=15, FL n=41, and @entity1074 n=19. The median age was 57 (35-84) years, and 55% were male. The overall response (OR) rate for all pts was 90% with 66% attaining a complete response (CR). Seventeen pts (25%) had a partial response, and stable disease was noted in 6 (9%). OR and CR rates were impressive in FL, with nearly all evaluable @entity1 34/39 (87%) attaining a CR. At study entry, 80% of FL pts had a FLIPI score of >=  2, and 54% met GELF criteria for high @entity5 burden. Responses were high regardless of FLIPI score or GELF (CR/CRu 90% with and 83% without GELF) criteria. Following cycle 6, nearly all FL @entity1 demonstrated molecular response with the absence of detectable @entity588 by PCR. At a median follow up of 14.4 (7-32.5) months, 4 @entity1 experienced @entity74 . The most common grade >=  3 non-hematologic @entity137 included @entity1910 (7 pts), @entity925 (7pts), @entity715 (3pts) and infection (3pts). Grade >= 3 @entity1398 and @entity882 occurred in 20 (27%) and 4 (5%) pts respectively. Five pts stopped treatment due to adverse events, all of which occurred during the first two cycles. CONCLUSIONS: The biologic agents @entity6985 and rituximab used as front line therapy produce excellent overall and complete response rates with manageable @entity137 in pts with indolent B cell @entity1893 . Randomized studies are planned utilizing this regimen in untreated @entity706 .

High response rates with XXXX plus rituximab for untreated indolent B-cell non-Hodgkin lymphoma, including those meeting GELF criteria.

@entity1 :: ('9606', 'Species') :: ['patients'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity', 'toxicities'] @entity588 :: ('596', 'Gene') :: ['BCL-2'] @entity1910 :: ('MESH:D005076', 'Disease') :: ['rash'] @entity882 :: ('MESH:D013921', 'Disease') :: ['thrombocytopenia'] @entity5 :: ('MESH:D009369', 'Disease') :: ['tumor'] @entity1074 :: ('MESH:D018442', 'Disease') :: ['marginal zone lymphoma'] @entity706 :: ('MESH:D008223', 'Disease') :: ['follicular lymphoma'] @entity1072 :: ('MESH:D015451', 'Disease') :: ['CLL'] @entity1398 :: ('MESH:D009503', 'Disease') :: ['neutropenia'] @entity74 :: ('MESH:D030342', 'Disease') :: ['progression of disease'] @entity6985 :: ('MESH:C467567', 'Chemical') :: ['Lenalidomide', 'lenalidomide'] @entity1893 :: ('MESH:D008228', 'Disease') :: ['NHL'] @entity715 :: ('MESH:D013927', 'Disease') :: ['thrombosis'] @entity925 :: ('MESH:D063806', 'Disease') :: ['muscle pain']
@entity6985 :: (MESH:C467567,Chemical) :: ['lenalidomide']
