Table 1.
Patient ID | Age, Gender | Diagnosis | Cumulative idelalisib dose | Cumulative lenalidomide dose | Cumulative rituximab dose | DLT | Off study for AE | Comments |
---|---|---|---|---|---|---|---|---|
1-001 | 53 yo M | MCL | 6300mg | 300mg | 2910mg | YES | YES | Developed fevers and grade 4 AST and ALT elevation on Day 20 |
1-002 | 59 yo M | MCL | 4300mg | 630mg | – | NO | YES | Grade 3 maculopapular rash on Day 15 |
1-003 | 66 yo F | MCL, blastoid | 3650mg | 690mg | – | YES | YES | Grade 3 AST elevation and grade 3 maculopapular rash |
2-001 | 59 yo M | FL | 45,800mg | 1260mg | 3600mg | NO | YES | Grade 3 lung infection |
2-002 | 62 yo F | FL | 4950mg | 160mg | 1088mg | YES | YES | Grade 4 septic shock on Day 17 |
2-003 | 47 yo M | FL | 5000mg | 560mg | 2852mg | NO | NO | Had grade 3 maculopapular rash during cycle 1 but resumed treatment with reduction of both idelalisib and lenalidomide |
2-004 | 77 yo F | FL | 4650mg | 360mg | 2864mg | NO | YES | Grade 3 allergic reaction and maculopapular rash during Cycle 1. Rash recurred despite omission and reductions of lenalidomide and idelalisib. |
2-005 | 53 yo F | FL | 3000mg | 100mg | 667mg | YES | YES | Patient developed fevers, facial edema, total body coalescent rash, hypotension 24 hours after rituximab administration. Admitted to ICU and on pressors. |
2-006 | 59 yo M | FL | 33,600mg | 1260mg | 3116mg | NO | NO | |
2-007 | 61 yo M | FL | 4500mg | 150mg | 770mg | YES | YES | Grade 3 maculopapular rash and grade 3 lung infection on Day 15 |
2-008 | 65 yo M | FL | 50,400mg | 1050mg | – | NO | NO |