Table 1.
Patient characteristics
| Subject number (initials) | 1 (MP) | 2 (RL) | 3 (RG) | 4 (RT) | 5 (RM) | 6 (JC) | 7 (BF) | 8 (JW) | 9 (LH) |
| ISF35 dose level | 1×108 | 1×108 | 1×108 | 3×108 | 3×108 | 3×108 | 1×109 | 1×109 | 1×109 |
| Age (years) | 75 | 70 | 30 | 78 | 70 | 70 | 71 | 71 | 59 |
| Sex | F | M | M | M | M | M | F | F | F |
| Year of diagnosis | 1998 | 1999 | 2002 | 1998 | 1994 | 2001 | 2003 | 1995 | 2003 |
| No. of previous treatments | 0 | 0 | 1 | 1 | 2 | 2 | 1 | 3 | 2 |
| Previous treatments | — | — | FCR | R+GM-CSF | FCR; R+GM-CSF |
R; R+GM-CSF |
R+GM-CSF | CVP; T cells; R+GM-CSF |
R+GM-CSF X2 |
| Rai stage | II | I | IV | I | IV | IV | I | IV | I |
| ALC (K/μl) | 43 | 58 | 14 | 105 | 66 | 72 | 37 | 75 | 54 |
| LDT (mo) | 6.8 | 18 | 2.7 | 5.2 | 5.2 | 6 | 5.3 | 8.8 | 6.5 |
| β-2M (mg/l) | 2.8 | 4.8 | 2.4 | 4.4 | 2.9 | 6.7 | 4.8 | NA | 2.1 |
| IGHV % Mutated | 7.8 | 12 | 0 | 0 | 7.6 | 0 | 1.8 | 7.1 | 2.4 |
| ZAP70-IHC | Negative | Positive | Positive | Positive | Negative | Positive | Positive | Negative | Positive |
| FISH | None | +12 | del 17p | del 17p | del 17p | None | del 11q | del 13q | del 17p |
| Cytogenetics | Diploid | Complex | Diploid | Diploid | Diploid | Diploid | del 11q | del 13q | Diploid |
| %CD38 Positive | 0.7 | 56 | 91 | 35 | 1 | 5 | 3 | 26 | 1.9 |
Abbreviations: ALC, absolute lymphocyte count; CVP, cyclophosphamide, vincristine, prednisone; F, female; FCR, fludarabine, cyclophosphamide, rituximab; FISH, fluorescence in situ hybridization (hierarchical categorization); GM-CSF, granulocyte macrophage colony stimulating factor; IGHV, immunoglobulin heavy chain variable gene; IHC, immunohistochemistry; LDT, lymphocyte doubling time; M, male; β-2M; β-2 microglobulin; mo, months; NA, not available; R, rituximab.