Table 3.

Summary of dose-escalation cohorts, lenalidomide dose levels, and DLTs

Cohort	Enrollment	Description	Lenalidomide dose level*	DLTs
1	n = 12	Starting dose	15 mg	• Grade 3 neutropenia lasting >7 d (n = 2) • Grade 3 rash (n = 2)
−1	n = 7	De-escalation dose	10 mg	• Grade 4 Salmonella sepsis (n = 1)
Protocol amendment to relax criteria for DLTs of neutropenia and rash, and to include management guidelines for toxicities
1+	n = 9	Re-escalation dose	15 mg	• Grade 4 neutropenia (n = 1)
2	n = 9	Phase 2 dose	20 mg	None
3	n = 8	Maximum dose level tested	25 mg	None

DLT, dose-limiting toxicity.

^*Lenalidomide dose in combination with 560 mg/day ibrutinib and 375 mg/m² intravenous rituximab.