Table 1. Patient Characteristics and Outcomes.
| Pt | Dose Level |
Time Dx to Tx |
ALC at Start |
Rai | β2M | FISH | IGVH | ZAP-70 | Course on Study | Response? | |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 1 | 48M | 12 m | 6.3 | 1 Bulky | 3.8 | Del 11q | UM | Pos | 3rd cycle delay and dose reduction for grade 3 ANC; Off study after 3 cycles, poor response |
SD |
| 2 | 1 | 37M | 31 m | 319 | 4 Bulky | 7.7 | Del 13q | UM | Pos | Cycle 1 Grade 4 ANC – DLT; Off study cycle 1 day 50, persistent neutropenia |
Not Evaluable |
| 3 | 1 | 59M | 66 m | 87.6 | 1 | 2.5 | Normal | Mut | Pos | Fever / rash / myalgia with grade 4 CK – DLT; Recurred at day 2 cycle 2 – off study |
Not Evaluable |
| 4 | 1 | 66M | 18 m | 15.0 | 3 | 4.1 | +12 | N/A | N/A | Completed 3 cycles; Off study with newly diagnosed 2nd malignancy, SCCa |
Not Evaluable |
| 5 | −1 | 63M | 44 m | 41.4 | 2 | 4.2 | Del 13q | N/A | N/A | Completed 6 cycles but no consolidation due to grade 3 AST / ALT during cycle 6 lenalidomide |
CR |
| 6 | −1 | 53M | 77 m | 9.51 | 4 Bulky | 4.2 | +12 | UM | Pos | Completed 3 cycles, off study due to 4 week treatment delay for persistent grade 2 thrombocytopenia; Consolidation 2 cycles |
PR |
| 7 | −1 | 57M | 67 m | 103.8 | 3 | 3.3 | Del 13q | N/A | N/A | 6 cycles plus 2 consolidation cycles | PR |
| 8 | −1 | 65F | 83 m | 199.4 | 4 | 2.8 | Del 13q | UM | Pos | Grade 4 ANC cycle 1 – DLT; Grade 4 ANC / platelets cycle 2 – dose reduced to DL–2; Grade 3 platelets cycle 3, and treatment delay cycle 4 for grade 2 platelets – off study |
PR |
| 9 | −1 | 59F | 78 m | 13.6 | 3 | 3.1 | Normal | V3-21 | Neg | 3 cycles, with recurrent tumor flare, grade 3 rash and hand-foot syndrome, and neutropenia; Off study |
nPR |