UNASSIGNED: ADMIRE was a multi-center, randomized-controlled, open, phase IIB superiority trial in previously untreated @entity1072 ( @entity1072 ). Conventional frontline therapy in fit @entity1 is @entity3118 , @entity786 and rituximab (FCR). Initial evidence from non-randomized Phase II trials suggested that the addition of @entity2664 to FCR (FCM-R) improved remission rates. 215 @entity1 were recruited to assess the primary endpoint of complete remission (CR) rates according to IWCLL criteria. Secondary endpoints were progression-free survival (PFS), @entity1349 ( @entity1349 ), overall response rate, @entity41 ( @entity41 ) negativity and safety. At final analysis, CR rates were 69.8% FCR vs 69.3% FCM-R [adjusted odds ratio (OR): 0.97; 95%CI: (0.53-1.79), P=0.932]. @entity41 -negativity rates were 59.3% FCR vs 50.5% FCM-R [adjusted OR: 0.70; 95% CI: (0.39-1.26), P=0.231]. During treatment, 60.0% (n=129) of @entity1 received @entity1261 as secondary prophylaxis for @entity1398 , a lower proportion on FCR compared with FCM-R (56.1 vs 63.9%). The @entity137 of both regimens was acceptable. There are no significant differences between the treatment groups for PFS and @entity1349 . The trial demonstrated that the addition of @entity2664 to FCR did not increase the depth of response. Oral FCR was well tolerated and resulted in impressive responses in terms of CR rates and @entity41 negativity compared to historical series with intravenous chemotherapy. @entity1778 accepted article preview online, 20 February 2017. doi:10.1038/leu.2017.65.

Results of the randomized phase IIB ADMIRE trial of FCR with or without @entity2664 in previously untreated XXXX .

@entity1 :: ('9606', 'Species') :: ['participants', 'patients'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity'] @entity1261 :: ('1440', 'Gene') :: ['G-CSF'] @entity41 :: ('MESH:D018365', 'Disease') :: ['MRD', 'minimal residual disease'] @entity2664 :: ('MESH:D008942', 'Chemical') :: ['mitoxantrone'] @entity786 :: ('MESH:D003520', 'Chemical') :: ['cyclophosphamide'] @entity1072 :: ('MESH:D015451', 'Disease') :: ['CLL', 'Chronic Lymphocytic Leukemia'] @entity3118 :: ('MESH:C024352', 'Chemical') :: ['fludarabine'] @entity1398 :: ('MESH:D009503', 'Disease') :: ['neutropenia'] @entity1778 :: ('MESH:D007938', 'Disease') :: ['Leukemia'] @entity1349 :: ('MESH:D011475', 'Disease') :: ['OS', 'overall survival']
@entity1072 :: (MESH:D015451,Disease) :: ['CLL']
