Table 2 Eligibility criteria of the FBTA05 trial
Inclusion criteria | - confirmed CLL, low-grade NHL or high-grade NHL |
| Â | - CD20 positivity |
| Â | - relapsed or refractory disease > 60 days after allogeneic transplantation |
| Â | - adequate hematological, liver and kidney functions |
|  | - platelet count ≥ 25 G/l |
|  | - ECOG performance status ≤ 2 |
| Â | - negative pregnancy test (adequate contraception during study in women of child bearing potential) |
Exclusion criteria | - anti-CD20 or anti-T cell antibody treatment < 3 months before FBTA05 treatment |
- positivity for human anti-mouse antibodies | |
- history of GVHD °III or °IV, or GVHD requiring steroid therapy with ≥ 10 mg / day | |
- known hypersensitivity to recombinant murine or rat proteins | |
- acute or uncontrolled chronic infections, viral infections at risk of reactivation (e.g. HCV, HBV, HIV) | |
- patients unable or unwilling to comply fully with the protocol |