Ph I/II Study of Subcutaneously Administered Veltuzumab (hA20) in NHL and CLL

The first study of veltuzumab given IV weekly in NHL patients (IM-T-hA20-01) has shown
excellent tolerability and even efficacy at weekly intravenous doses as low as 80-120 mg/m2
over 4 consecutive weeks. These clinical results confirm experiments laboratory studies.
Laboratory studies using Veltuzumab administered subcutaneously showed potent activity based
on B-cell depletion. The current study's goal is to determine if a subcutaneous (SC) dosing
schedule of veltuzumab can be established in patients with NHL or CLL

Inclusion Criteria:

- Histologically confirmed diagnosis of CD20 positive chronic lymphocytic leukemia
(CLL)

- Either previously untreated or relapsed

- Measurable disease (at least one lesion > 1.5 cm for NHL, or ALC > 5,000 for CLL) see
full protocol for additional criteria

Exclusion Criteria:

- Previously untreated NHL patients with Stage I and II disease (Ann Arbor
classification)

- Previously untreated CLL patients with Stage 0-2 disease (Rai classification) unless
specific treatment indications by NCCN guidelines exist (symptomatic, recurrent
infections, end-organ function, cytopenias and steady disease progression).

see full protocol for additional criteria