Table 1.

Selection of ongoing/planned trials for venetoclax-based therapy in previously untreated CLL

Active diseaseStudy IDExperimental agent(s) and comparatorNStatusTrial registration
 FLAIR Fludarabine-cyclophosphamide-rituximab vs ibrutinib vs ibrutinib-venetoclax 1516 Recruiting ISRCTN01844152 
CLL13 Fludarabine-cyclophosphamide-rituximab/bendamustine-rituximab vs venetoclax-rituximab vs venetoclax-obinutuzumab vs obinutuzumab-ibrutinib-venetoclax 920 Recruitment completed NCT02950051 
National Cancer Institute (ECOG 9161) Ibrutinib-obinutuzumab vs obinutuzumab-ibrutinib-venetoclax in untreated younger patients 720 Recruiting NCT03701282 
National Cancer Institute (Alliance 041702) Ibrutinib-obinutuzumab vs obinutuzumab-ibrutinib-venetoclax in untreated older patients 454 Recruiting NCT03737981 
 CLL17 Ibrutinib vs venetoclax-obinutuzumab vs ibrutinib-venetoclax 920 In preparation EudraCT 2019-003854-99 
Active diseaseStudy IDExperimental agent(s) and comparatorNStatusTrial registration
 FLAIR Fludarabine-cyclophosphamide-rituximab vs ibrutinib vs ibrutinib-venetoclax 1516 Recruiting ISRCTN01844152 
CLL13 Fludarabine-cyclophosphamide-rituximab/bendamustine-rituximab vs venetoclax-rituximab vs venetoclax-obinutuzumab vs obinutuzumab-ibrutinib-venetoclax 920 Recruitment completed NCT02950051 
National Cancer Institute (ECOG 9161) Ibrutinib-obinutuzumab vs obinutuzumab-ibrutinib-venetoclax in untreated younger patients 720 Recruiting NCT03701282 
National Cancer Institute (Alliance 041702) Ibrutinib-obinutuzumab vs obinutuzumab-ibrutinib-venetoclax in untreated older patients 454 Recruiting NCT03737981 
 CLL17 Ibrutinib vs venetoclax-obinutuzumab vs ibrutinib-venetoclax 920 In preparation EudraCT 2019-003854-99 

All are phase 3, multicenter, open-label trials. No results have been submitted.

Active disease, according to iwCLL criteria (ref. 19); ECOG, Eastern Cooperative Oncology Group.

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