Baseline characteristics and treatment outcomes
| Dose level . | Age/sex . | Prognostic features . | No. of prior regimens . | Prior regimens . | ANC, ×109/L . | Platelets, ×109/L . | Hgb, g/dL . | Best response . | Duration of therapy, mo . | Indication for study withdrawal . |
|---|---|---|---|---|---|---|---|---|---|---|
| DL1 | 75/M | del 13q, trisomy 12, unmutated | 1 | B+R | 9.9 | 157 | 8.3 | SD | 3 | Grade 4 neutropenia |
| DL1 | 50/M | Mutated, normal FISH | 3 | Fl+R + oblimersen; second-generation CD20 antibody; B+R | 3.8 | 113 | 12.6 | SD | 4 | Grade 4 neutropenia |
| DL1 | 63/M | IGVH unavailable, normal FISH | 1 | B+R | 7.6 | 209 | 14.4 | PD | 2 | Progressive disease |
| DL2 | 65/M | IGVH unavailable, trisomy 12 | 1 | Fl+R | 3.4 | 118 | 14 | PR | 8 | Grade 4 neutropenia |
| DL2 | 75/M | IGVH unavailable, del 13q, trisomy 12, complex karyotype | 3 | Fl+R; B+L; second-generation PI3K inhibitor | 11.3 | 101 | 9.7 | PR | 25+ | NA |
| DL2 | 53/F | Unmutated | 2 | Fl+R followed by L; R + idelalisib | 2.3 | 203 | 12.3 | CR | 23+ | NA |
| DL2 | 70/M | Unmutated, trisomy 12 | 1 | R-CVP | 8.7 | 141 | 10.4 | PR | 15+ | NA |
| DL2 | 59/M | Unmutated, del 17p, complex karyotype | 1 | B+R | 3.0 | 90 | 14.3 | PR | 19+ | NA |
| DL2 | 69/M | Unmutated, del 13q, del 11p, complex karyotype | 3 | Fl+R followed by L; R + idelalisib; venetoclax | 3.5 | 140 | 13.9 | PR | 7 | PD |
| DL3 | 69/F | Unmutated, del 11q, del 13p | 7 | Fl; Fl+R; PCR; B+R; alemtuzumab; B+R; R + idelalisib | 1.0 | 85 | 9.8 | PR | 4 | Grade 4 neutropenia |
| DL3 | 54/M | Unmutated, del 13q | 1 | B+R | 3.7 | 102 | 16.6 | PR | 20+ | NA |
| DL3 | 61/M | Unmutated, normal FISH | 1 | Fl+C+R | 2.1 | 46 | 8.9 | Not evaluable | 1 | Grade 4 neutropenia with grade 3 hemolytic anemia |
| Dose level . | Age/sex . | Prognostic features . | No. of prior regimens . | Prior regimens . | ANC, ×109/L . | Platelets, ×109/L . | Hgb, g/dL . | Best response . | Duration of therapy, mo . | Indication for study withdrawal . |
|---|---|---|---|---|---|---|---|---|---|---|
| DL1 | 75/M | del 13q, trisomy 12, unmutated | 1 | B+R | 9.9 | 157 | 8.3 | SD | 3 | Grade 4 neutropenia |
| DL1 | 50/M | Mutated, normal FISH | 3 | Fl+R + oblimersen; second-generation CD20 antibody; B+R | 3.8 | 113 | 12.6 | SD | 4 | Grade 4 neutropenia |
| DL1 | 63/M | IGVH unavailable, normal FISH | 1 | B+R | 7.6 | 209 | 14.4 | PD | 2 | Progressive disease |
| DL2 | 65/M | IGVH unavailable, trisomy 12 | 1 | Fl+R | 3.4 | 118 | 14 | PR | 8 | Grade 4 neutropenia |
| DL2 | 75/M | IGVH unavailable, del 13q, trisomy 12, complex karyotype | 3 | Fl+R; B+L; second-generation PI3K inhibitor | 11.3 | 101 | 9.7 | PR | 25+ | NA |
| DL2 | 53/F | Unmutated | 2 | Fl+R followed by L; R + idelalisib | 2.3 | 203 | 12.3 | CR | 23+ | NA |
| DL2 | 70/M | Unmutated, trisomy 12 | 1 | R-CVP | 8.7 | 141 | 10.4 | PR | 15+ | NA |
| DL2 | 59/M | Unmutated, del 17p, complex karyotype | 1 | B+R | 3.0 | 90 | 14.3 | PR | 19+ | NA |
| DL2 | 69/M | Unmutated, del 13q, del 11p, complex karyotype | 3 | Fl+R followed by L; R + idelalisib; venetoclax | 3.5 | 140 | 13.9 | PR | 7 | PD |
| DL3 | 69/F | Unmutated, del 11q, del 13p | 7 | Fl; Fl+R; PCR; B+R; alemtuzumab; B+R; R + idelalisib | 1.0 | 85 | 9.8 | PR | 4 | Grade 4 neutropenia |
| DL3 | 54/M | Unmutated, del 13q | 1 | B+R | 3.7 | 102 | 16.6 | PR | 20+ | NA |
| DL3 | 61/M | Unmutated, normal FISH | 1 | Fl+C+R | 2.1 | 46 | 8.9 | Not evaluable | 1 | Grade 4 neutropenia with grade 3 hemolytic anemia |
ANC, absolute neutrophil count; B, bendamustine; C, cyclophosphamide; F, female; Fl, fludarabine; Hgb, hemoglobin; L, lenalidomide; M, male; NA, not applicable; PCR, pentostatin, cyclophosphamide, rituximab; PD, progressive disease; PI3K, phosphatidylinositol 3-kinase; PR, partial response; R, rituximab; R-CVP, rituximab, cyclophosphamide, vincristine, prednisone.