PHASE II CLINICAL PROTOCOL FOR THE TREATMENT OF PATIENTS WITH RELAPSED/REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA WITH A COMBINATION OF BENDAMUSTINE AND OFATUMUMAB

Inclusion Criteria:

- Must be >/= 18 years old and able to provide consent

- Must have diagnosis of CLL as defined by NCI criteria

- Must require chemotherapy

- Must be previously treated with a minimum of one course of prior chemo or other
treatment

- Serum creatinine <1.8 mg/dl

- Bilirubin must be
- Must have adequate liver function (as defined as <2x ULN, unless related to CLL)

- AST/ALT <2x ULN

- Performance status 0-2

- Women of child bearing age must be willing to use accepted/effective method of birth
control.

Exclusion Criteria:

- Not have received prior treatment with cytotoxic chemotherapy or immunotherapy.

- Not have autoimmune hemolytic anemia or autoimmune thrombocytopenia

- Not have history of corticosteroid treatment for CLL

- Not have CNS disease

- Not have clinically significant infections

- Patients with a second malignancy, other than basal cell carcinoma of the skin or in
situ carcinoma of the cervix are not eligible.

- Not have positive serology for Hepatitis B or Hepatitis C

- Not have be known to be HIV positive

- Not have New York Classification III or IV hear disease

Other protocol specific criteria may apply