Table 1.
Baseline demographic and disease characteristics
| Baseline characteristics | N = 91 |
|---|---|
| Male,n(%) | 52 (57.1) |
| Median age (range), years | 61.0 (35–87) |
| ECOG PS,n(%) | |
| 0/1 | 88 (96.7) |
| 2 | 3 (3.3) |
| CLL,n(%) | 82 (90.1) |
| SLL,n(%) | 9 (9.9) |
| Median time since initial diagnosis, months (range) | 39.4 (3.2–185.1) |
| Number of prior lines of therapy | |
| Median | 1.0 |
| Min, max | 1, 9 |
| ≥ 2 prior lines of therapy, n (%) | 45 (49.5) |
| Bulky disease,an(%) | 40 (44.0) |
| Binet stage at study entry for CLL patientsb,n(%) | |
| Stage A/B | 27 (32.9) |
| Stage C | 55 (67.1) |
| Ann Arbor stage at study entry for SLL patients,n(%) | |
| Stage I | 1 (11.1) |
| Stage III/IV | 8 (88.9) |
| β2 microglobulin > 3.5 mg/L,n(%) | 68 (74.7) |
| Unmutated IGHV,cn(%) | 51 (56.0) |
| Del(17p) orTP53mutation,n(%) | 22 (24.2) |
| Del(13q),n(%) | 41 (45.1) |
| Del(11q),n(%) | 20 (22.0) |
| Prior anticancer drug therapy,n(%)d | |
| Alkylating agents (including bendamustine) | 68 (74.7) |
| Nucleoside analogs | 52 (57.1) |
| Anti-CD20-based therapy | 54 (59.3) |
| Anti-CD20-based chemoimmunotherapy | 44 (48.4) |
| Lenalidomide/thalidomide | 7 (7.7) |
| Other therapies | 12 (13.2) |
| Refractory to last systemic therapy,n(%) | 72 (79.1) |
CLL chronic lymphocytic leukemia, ECOG PS Eastern Cooperative Oncology Group performance status, IGHV immunoglobulin heavy-chain variable region, LDi longest diameter, max maximum, min minimum, SLL small lymphocytic lymphoma
aBulky disease refers to ≥ 1 lesion with LDi ≥ 5 cm
bn = 82
cThe IGHV mutational status was unknown in 17 patients for the following reasons: IGHV gene rearrangement undetected (three patients); multiclonal IGHV gene rearrangement detected (13 patients); test failed (one patient)
dNucleoside analog is defined as any regimen that includes fludarabine; alkylating agent is defined as any regimen that includes an alkylator without fludarabine; anti-CD20-based therapy is defined as any regimen that includes rituximab either alone or with other regimen components; anti-CD20-based chemoimmunotherapy is defined as any regimen that includes both rituximab and cytotoxic agents. Other includes VDAE (vindesine, methylprednisolone, pirarubicin, and etoposide), DEMP (vindesine, methylprednisolone, mitoxantrone, and etoposide), ESHAP (etoposide, cisplatin, cytarabine, with or without mercaptopurine or prednisone), GP (gemcitabine and oxaliplatin), anti-CD52 monoclonal antibody, methylprednisolone only, cisplatin and dendritic cell-activated, cytokine-induced killer cells (DCCIK), and interferon only. The categories are not mutually exclusive