Phase I/II Study of Ublituximab in Combination With Lenalidomide (Revlimid®) in Patients With B-Cell Lymphoid Malignancies Who Have Relapsed or Are Refractory After CD20 Directed Antibody Therapy

Inclusion Criteria:

- Relapsed or refractory B-cell non-Hodgkins Lymphoma (NHL), Chronic Lymphocytic
Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

- Patients must have received at least one prior line of therapy with an anti-CD20
antibody (i.e. rituximab, ofatumumab, etc.) or an anti-CD20 antibody containing
regimen

- Measurable or evaluable Disease

- Eastern Cooperative Oncology Group performance status 0, 1 or 2

- Patients ineligible for high dose or combination chemotherapy + stem cell transplant

- No active or chronic infection of Hepatitis B or C and no history of HIV based on
negative serology

- All study participants must be registered into the mandatory RevAssist® program, and
be willing and able to comply with the requirements of RevAssist®

Exclusion Criteria:

- Prior chemotherapy, investigational therapy or radiotherapy within 3 weeks of study
entry

- Prior autologous or allogeneic stem cell transplantation within 6 months of study
entry

- History of severe hypersensitivity or anaphylaxis to prior murine or mouse/human
chimeric antibodies, or to any component of ublituximab, or with prior lenalidomide
or thalidomide

- Uncontrolled inter-current illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness that would limit compliance with study
requirements

- History of deep vein thrombosis (DVT) or pulmonary embolus (PE) in the six months
prior to Day 1 of Cycle 1

- Pregnant women