BACKGROUND: Standard treatments for indolent @entity1893 are often toxic, and most @entity1 ultimately relapse. @entity6985 , an immunomodulatory agent, is effective as monotherapy for relapsed indolent @entity1893 . We assessed the efficacy and safety of @entity6985 plus rituximab in @entity1 with untreated, advanced stage indolent @entity1893 . METHODS: In this phase 2 trial, undertaken at one instution, @entity1 with @entity706 and @entity1074 were given @entity6985 , orally, at 20 mg/day on days 1-21 of each 28-day cycle. For @entity1 with @entity1072 , dosing began at 10 mg/day to avoid @entity5 flare, with an escalation of 5 mg/month to 20 mg/day. Rituximab was given at 375 mg/m(2) as an intravenous infusion on day 1 of each cycle. @entity1 responding after six cycles could continue therapy for up to 12 cycles. The primary endpoint was overall response, defined as the proportion of @entity1 who achieved a partial or complete response; @entity1 were assessed for response if they had any post-baseline @entity5 assessment. This trial is registered with ClinicalTrials.gov, number NCT00695786. FINDINGS: 110 @entity1 with @entity706 (n=50), @entity1074 (n=30), and @entity1072 (n=30) were enrolled from June 30, 2008, until Aug 12, 2011. 93 of 103 evaluable @entity1 had an overall response (90%, 95% CI 83-95). Complete responses occurred in 65 (63%, 95% CI 53-72) and partial responses in 28 @entity1 (27%, 19-37). Of 46 evaluable @entity1 with @entity706 , 40 (87%) @entity1 had a complete response and five (11%) had a partial response. Of 27 evaluable @entity1 with @entity1074 , 18 (67%) had a complete response and six (22%) had a partial response. Of 30 evaluable @entity1 with @entity1072 , seven (23%) had a complete response and 17 (57%) had a partial response. The most common grade 3 or 4 adverse events were @entity1398 (38 [35%] of 110 @entity1 ), @entity925 (ten [9%]), @entity1910 (eight [7%]), cough, dyspnoea, or other @entity358 (five [5%]), @entity1295 (five [5%]), @entity715 (five [5%]), and @entity882 (four [4%]). INTERPRETATION: @entity6985 plus rituximab is well tolerated and highly active as initial treatment for indolent @entity1893 . An international phase 3 study (NCT01476787) to compare this regimen with chemotherapy in @entity1 with untreated @entity706 is in progress. FUNDING: Celgene Corporation and Richard Spencer Lewis Memorial Foundation and Cancer Center Support Grant.

Safety and activity of @entity6985 and rituximab in untreated XXXX : an open-label, phase 2 trial.

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients'] @entity706 :: ('MESH:D008223', 'Disease') :: ['follicular lymphoma'] @entity1910 :: ('MESH:D005076', 'Disease') :: ['rash'] @entity5 :: ('MESH:D009369', 'Disease') :: ['tumour'] @entity1074 :: ('MESH:D018442', 'Disease') :: ['marginal zone lymphoma'] @entity882 :: ('MESH:D013921', 'Disease') :: ['thrombocytopenia'] @entity1295 :: ('MESH:D005221', 'Disease') :: ['fatigue'] @entity1072 :: ('MESH:D015451', 'Disease') :: ['small lymphocytic lymphoma'] @entity1398 :: ('MESH:D009503', 'Disease') :: ['neutropenia'] @entity358 :: ('MESH:D008171', 'Disease') :: ['pulmonary symptoms'] @entity6985 :: ('MESH:C467567', 'Chemical') :: ['Lenalidomide', 'lenalidomide'] @entity1893 :: ('MESH:D008228', 'Disease') :: ['non-Hodgkin lymphoma', 'non-Hodgkin lymphomas'] @entity715 :: ('MESH:D013927', 'Disease') :: ['thrombosis'] @entity925 :: ('MESH:D063806', 'Disease') :: ['muscle pain']
@entity706 :: (MESH:D008223,Disease) :: ['indolent lymphoma']
