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. 2019 Nov 20;134(21):1796–1801. doi: 10.1182/blood.2019001321

Table 2.

Relevant phase 3 clinical trials in CLL

Trial Regimens compared ORR, % PFS OS Results
CLL831 FC 80 Median, 32.9 mo Median, 86 mo FCR is superior to FC in terms of PFS
FCR 90 Median, 56.8 mo Median, not reached FCR is superior to FC in terms of PFS
CLL1021 FCR 95 Median, 55.2 mo 3-y, 91% BR is inferior to FCR in terms of PFS
BR 96 Median, 41.7 mo 3-y, 92%
CLL1120 Ch 65.7 Median, 11.1 mo NR ChO is superior to Ch and ChR in terms of PFS and OS
ChR 31.4 Median, 15.4 mo NR
ChO 77.3 Median, 29.2 mo NR
RESONATE 226 Ch 35 24-mo, 34% 24-mo, 84% Ibrutinib is superior to Ch in terms of PFS and OS
Ibrutinib 92 24-mo, 89% 24-mo, 95%
E191234 IR 96 3-y, 89% 3-y, 99% IR is superior to FCR in terms of PFS and OS
FCR 81 3-y, 73% 3-y, 92%
A04120228 BR 81 2-y, 74% 2-y, 95% Ibrutinib and IR are superior to BR in terms of PFS, IR is no more effective than ibrutinib in terms of PFS
Ibrutinib 93 2-y, 87% 2-y, 90%
IR 94 2-y, 88% 2-y, 94%
iLLUMINATE30 ChO 73 30-mo, 31% 30-mo, 85% IO is superior to ChO in terms of PFS
IO 88 30-mo, 79% 30-mo, 86%
CLL1435 ChO 71.3% 2-y, 64.1% 2-y, 93.3% VO is superior to ChO in terms of PFS
VO 84.7% 2-y, 88.2% 2-y, 91.8%

BR, bendamustine/rituximab; Ch, chlorambucil; ChO, chlorambucil/obinutuzumab; ChR, chlorambucil/rituximab; FC, fludarabine/cyclophosphamide; FCR, fludarabine/cyclophosphamide/rituximab; IO, ibrutinib/obinutuzumab; IR, ibrutinib/rituximab; iwCLL, International Working Group on CLL; NR, not reported; ORR, overall response rate; OS, overall survival; PFS, progression-free survival.