Table 2:
Cycle 3 (n=85) | Post-iFCR* (n=85) | Best Response (n=85) | |
---|---|---|---|
CR† | 9 (10·6%) | 20 (23·5%) | 51 (60·0%) |
CRi† | 6 (7·1%) | 10 (11·8%) | 5 (5·9%) |
PR | 59 (69·4%) | 52 (61·2%) | 28 (32·9%) |
CR or CRi or PR | 74 (87·1%) | 82 (96·5%) | 84 (98·8%) |
BM-MRD− | 40 (47·1%) | 66 (77·6%) | 71 (83·5%) |
BM-MRD+ | 38 (44·7%) | 14 (16·5%) | 14 (16·5%) |
BM-MRD UNK | 7 (8·2%) | 5 (5·9%) | 0 |
CR/MRD− | 5 (5·9%) | 19 (22·4%) | NA‡ |
CR/MRD+ | 4 (4·7%) | 1 (1·2%) | NA‡ |
CRi/MRD− | 4 (4·7%) | 9 (10·6%) | NA‡ |
CRi/MRD+ | 1 (1·2%) | 1 (1·2%) | NA‡ |
PR/MRD− | 31 (36·5%) | 38 (44·7%) | NA‡ |
PR/MRD+ | 28 (32·9%) | 12 (14·1%) | NA‡ |
BM-uMRD=minimal residual disease in the bone marrow. CR=complete response. CRi=complete response with incomplete count recovery. FCR=fludarabine, cyclophosphamide, plus rituximab. MRD=minimum residual disease. NA=not applicable. PR=partial response. UNK=unknown.
Post-iFCR evaluations occurred at 1 month instead of 2 months in seven patients due to scheduling issues.
CR and CRi were combined when evaluating the primary trial endpoint of BM-uMRD CR post-iFCR.
Because of optional sampling times and missed samples, the best response cannot be defined and are listed as NA.