Table 1.
Patient and disease characteristics
| Characteristic | Part 1 (N = 12) | Part 2 | |
|---|---|---|---|
| CLL/SLL (n = 45) | R/R FL (n = 36) | ||
| Age, y | |||
| Median | 68 | 68 | 59 |
| Range | 51-86 | 38-82 | 34-86 |
| ECOG PS | |||
| 0 | 9 | 20 (44) | 28 (78) |
| 1 | 2 | 24 (53) | 6 (17) |
| 2 | 1 | 1 (2) | 2 (6) |
| Prior treatment status | |||
| TN | 0 | 20 (44) | 0 |
| R/R | 12 | 25 (56) | 36 (100) |
| Rituximab-refractory status for R/R FL* | |||
| Refractory | — | — | 14 (39) |
| Not refractory or unknown | — | — | 22 (61) |
| Refractory to most recent line of therapy* | |||
| Refractory | — | — | 12 (33) |
| Not refractory or unknown | — | — | 24 (67) |
| Prior therapies for patients with R/R disease† | n = 25 | n = 36 | |
| Median | 2 | 1 | 2 |
| Range | 1-9 | 1-4 | 1-9 |
| Bulky disease, cm | |||
| Node >5 | — | 15 (33) | 17 (47) |
| Node >10 | — | 0 | 4 (11) |
| Molecular risk factors (n = 39) | |||
| Unmutated IGHV | — | 19 (49) | — |
| Del(17p)/p53 mutation | — | 16 (41) | — |
| Del(11q) | — | 10 (26) | — |
| Complex karyotype | — | 9 (23) | — |
Values are n (%) except as noted.
ECOG PS, Eastern Cooperative Oncology Group performance status; PI3K, phosphoinositide 3-kinase.
Refractoriness was defined per protocol as less than partial response or PD within 6 mo after completion of prior rituximab-containing therapy (single agent or combination). Missing dates for some patients’ prior lines of therapy limited the number of definitely rituximab-refractory or refractory patients identified; where critical dates were missing, we classified patients conservatively as non–rituximab refractory or unknown.
Prior therapies included nucleoside analogs (fludarabine, gemcitabine, cytarabine, methotrexate), alkylating agents (cyclophosphamide, chlorambucil, bendamustine, ifosfamide, carmustine, melphalan, cisplatin, oxaliplatin, carboplatin), anthracyclines (doxorubicin, epirubicin, pirarubicin), topoisomerase inhibitors (etoposide, mitoxantrone), vinca alkyloids (vinorelbine, vincristine), anti-CD20 agents (rituximab, ofatumumab), BCL2 inhibitor (navitoclax), corticosteroids (dexamethasone, prednisone, prednisolone), histone deacetylase inhibitor (panobinostat), immunomodulators (lenalidomide), PI3K inhibitor (idelalisib), and dual-affinity retargeting antibody.