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 |
| 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.