Baseline demographics and prior treatment
| Characteristic . | All DLBCL (n = 97)* . |
|---|---|
| Age (y), median | 62 (25-91) |
| Age >65 y | 35 (36) |
| Male | 55 (57) |
| ECOG PS | |
| 0 | 28 (29) |
| 1 | 63 (65) |
| 2 | 6 (6) |
| Ann Arbor stage | |
| I/II | 22 (23) |
| III/IV | 75 (77) |
| No. of prior systemic cancer therapies | |
| 1-2 | 34 (35) |
| ≥3 | 63 (65) |
| Median (range) | 3 (1-13) |
| Prior radiation | 33 (34) |
| Median (range) | 1 (1-4) |
| Response to last prior therapy | |
| PR/CR | 26 (27) |
| SD/PD | 60 (62) |
| Response to R-CHOP <CR† | 50 (49)† |
| Relapse ≤1 y after ASCT | 14 (14) |
| Chemorefractory DLBCL‡ | 62 (64) |
| DLBCL subtype | |
| DLBCL, de novo | 85 (88) |
| Transformed lymphoma§ | 12 (12) |
| Median (range) tumor burden, SPD, cm2 | 29 (2-286) |
| Elevated LDH (>ULN) | 69 (71) |
| Characteristic . | All DLBCL (n = 97)* . |
|---|---|
| Age (y), median | 62 (25-91) |
| Age >65 y | 35 (36) |
| Male | 55 (57) |
| ECOG PS | |
| 0 | 28 (29) |
| 1 | 63 (65) |
| 2 | 6 (6) |
| Ann Arbor stage | |
| I/II | 22 (23) |
| III/IV | 75 (77) |
| No. of prior systemic cancer therapies | |
| 1-2 | 34 (35) |
| ≥3 | 63 (65) |
| Median (range) | 3 (1-13) |
| Prior radiation | 33 (34) |
| Median (range) | 1 (1-4) |
| Response to last prior therapy | |
| PR/CR | 26 (27) |
| SD/PD | 60 (62) |
| Response to R-CHOP <CR† | 50 (49)† |
| Relapse ≤1 y after ASCT | 14 (14) |
| Chemorefractory DLBCL‡ | 62 (64) |
| DLBCL subtype | |
| DLBCL, de novo | 85 (88) |
| Transformed lymphoma§ | 12 (12) |
| Median (range) tumor burden, SPD, cm2 | 29 (2-286) |
| Elevated LDH (>ULN) | 69 (71) |
Data are presented as n (%) unless otherwise noted.
LDH, lactic acid dehydrogenase; PD, progressive disease; PR, partial response; R-CHOP, rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone; R/R, relapsed/refractory; SD, stable disease; SPD, sum of products of diameters; ULN, upper limit of normal.
One subject with DLBCL from the avadomide HCl 3-mg daily cohort discontinued and re-entered the study with a new ID and treatment regimen (avadomide 3 mg 5/7 days). These 2 IDs are counted as separate subjects in the safety analysis, and only the first enrollment of this subject was considered in the efficacy analysis.
Eighty-nine patients (92%) received R-CHOP or a comparable prior therapy (eg, obinutuzumab-CHOP or etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, rituximab [EPOCH-R]); 6 out of 89 had no recorded steroid in their prior anticancer therapy record. The remaining 8 patients had less intense rituximab-containing chemotherapy (eg, rituximab, cyclophosphamide, vincristine, prednisone [R-CVP]) or no anti-CD-20 containing regimen (2/89).
Chemorefractory DLBCL defined as stable disease/progressive disease as best response to chemotherapy or relapse <12 months after ASCT.12
Transformed lymphoma included follicular lymphoma, marginal zone lymphoma, Hodgkin lymphoma, small B cell, chronic lymphocytic leukemia, and other indolent lymphomas.