A Phase I, Sequential Cohort, Dose Escalation Trial to Determine the Safety, Tolerability, and Maximum Tolerated Dose of GRN163L in Patients With Chronic Lymphoproliferative Disease

Inclusion Criteria:

- 18 years of age or older

- Male or female

- Chronic lymphoproliferative disease with related biology or similar clinical pattern
to B-Cell Leukemia (CLL)including: small lymphocytic lymphoma (SLL), T cell
prolymophocytic leukemia (T-PLL), B cell prolymphocytic leukemia (B-PLL), mantle cell
lymphoma or other non-Hodgkins lymphoma in leukemic phase (peripheral blood
circulating malignant cells present), Waldenstrom's macroglobulinemia

- Must have relapsed from or be refractory to prior therapeutic regimens

- Patients with CLL or SLL must have received at least one prior purine analogue-based
chemotherapy regimen (eg, fludarabine, pentostatin or cladribine)

- If previously treated with an anthracycline, anthracenedione, or trastuzumab, must
have left ventricular ejection fraction > 50%

- ECOG performance status 0-2

- Life expectancy 3 months or greater

Exclusion Criteria:

- Pregnant or lactating women

- Active 2nd malignancy or history of another malignancy within 2 years,
except:treated, non-melanoma skin cancer,treated breast or cervical carcinoma in
situ,or resected T1a or b prostate cancer

- Chemotherapeutic agents within 4 weeks prior to study

- High dose CTX with stem cell support within 6 months prior to study

- Signal transduction inhibitors,or monoclonal antibodies within 4 weeks prior to study

- Immunotherapy or biological response modifiers within 4 weeks prior to study

- Systemic hormonal therapy within 4 weeks prior to study

- Anticoagulant therapy, antiplatelet therapy within 2 weeks prior to study

- Radiotherapy within 4 weeks prior to study

- Active autoimmune disorder

- Central nervous system or leptomeningeal involvement

- Clinically significant cardiovascular disease

- Known HIV infection

- Serious/active infection

- Surgical procedure within 2 weeks