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. 2014 Jul 21;32(27):3039–3047. doi: 10.1200/JCO.2014.55.8262

Table 2.

Ongoing Phase III Studies With Potential to Change Standard of Care in CLL

Study Treatment Comparison Treatment Status Age Group (years)
CLL12 Ibrutinib v placebo High risk, aymptomatic ≥ 18
RESONATE II CLB v ibrutinib (crossover) Symptomatic, untreated ≥ 65
A041202 BR v ibrutinib plus rituximab v ibrutinib (crossover) Symptomatic, untreated ≥ 65
E1912 FCR v IR Symptomatic, untreated < 70
NCT01980888 BR plus placebo v BR plus idelalisib Symptomatic, untreated ≥ 18
NCT01980875 Idelalisib plus rituximab v placebo plus rituximab or idelalisib plus CLB v placebo plus CLB Symptomatic, untreated ≥ 65
CLLM1 Lenaldiomide v placebo for consolidation after initial therapy Consolidation after first treatment ≥ 18
RESONATE Ofatumumab v ibrutinib Relapsed ≥ 18
NCT01611090 BR plus placebo v BR plus ibrutinib Relapsed ≥ 18
NCT01569295 BR plus placebo v BR plus idelalisib Relapsed ≥ 18
NCT02005471 ABT199 plus rituximab v BR Relapsed ≥ 18

Abbreviations: BR, bendamustine plus rituximab; CLB, chlorambucil; CLL, chronic lymphocytic leukemia; FCR, fludarabine, cyclophosphosphamide, and rituximab; IR, ibrutinib plus rituximab; RESONATE, A Phase III Study of Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia; RESONATE II, A Multicenter, Open-Label, Phase III Study of the Bruton's Tyrosine Kinase Inhibitor PCI-32765 Versus Chlorambucil in Patients 65 Years or Older With Treatment-Naive Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma.