Phase I Trial With Cohort Expansion of Pentostatin, Bendamustine and Ofatumumab (PBO) for the Treatment of Chronic Lymphocytic Leukemia and Non-Hodgkin's Lymphoma

Inclusion Criteria:

1. Previously treated CLL or other B-cell neoplasm including small lymphocytic lymphoma,
hairy cell leukemia, follicular, lymphoma, Waldenstrom's macroglobulinemia, marginal
zone lymphomas, mantle cell lymphomas, lymphoplasmacytic lymphoma and diffuse large
B-cell lymphoma. Patients with composite lymphoma and transformed disease will be
included. Immunophenotypic (or immunohistochemical) analysis of the malignant
lymphocytes should demonstrate that the cells are B-cells.

2. Patients must have had prior cytotoxic therapy for their disease. Patients with
diffuse large B-cell lymphoma must have been treated with at least 2 prior cytotoxic
therapies.

3. Age ≥ 18 years of age.

4. ECOG performance statue 0 to 2.

5. Reasonable life-expectancy greater than 12 weeks.

6. Patients with autoimmune hemolytic anemia or autoimmune thrombocytopenia will be
eligible for treatment.

7. Signed informed consent, which indicates the investigational nature of this study, is
required.

8. No patient may be entered onto the study without consultation with the principal
investigator or his designee.

Exclusion Criteria:

1. Subjects who have current active hepatic or biliary disease (with exception of
patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable
chronic liver disease per investigator assessment)

2. No prior cytotoxic therapy for at least 4 weeks before enrollment.

3. Currently participating in any other interventional clinical study.

4. Other currently active malignancy.

5. Active uncontrolled infection.

6. History of significant cerebrovascular disease in the past 6 months or ongoing event
with active symptoms or sequelae.

7. Known HIV positive.

8. Clinically significant cardiac disease including unstable angina, acute myocardial
infarction within six months prior to randomization, congestive heart failure (NYHA
III-IV), and uncontrolled symptomatic arrhythmia.

9. Significant concurrent, uncontrolled medical condition including, but not limited to,
renal, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric
disease which in the opinion of the investigator may represent a risk for the
patient.

10. Positive serology for hepatitis B (HB) defined as a positive test for HBsAg. In
addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HB
DNA test will be performed and if positive the subject will be excluded.

11. Active hepatitis C infection. If positive serology for hepatitis C (HC) defined as a
positive test for HCAb, HC quantitative PCR will be performed. If PCR is positive the
subject will be excluded

12. Screening laboratory values:

1. creatinine > 2.0 times upper normal limit and creatinine clearance < 30
ml/min/m2. Patients with creatinine > 2 times upper limit of normal will have
creatinine clearance estimated. At the discretion of treating physician,
creatinine clearance can be measured and that value can be used instead of
calculated creatinine clearance.

2. total bilirubin > 2 times upper normal limit (unless due to tumor involvement of
liver or a known history of Gilbert's disease)

3. ALT (alanine transaminase) > 2.5 times upper normal limit (unless due to disease
involvement of liver.

13. Pregnant or lactating women. Women of childbearing potential must have a negative
pregnancy test at screening.

14. Women of childbearing potential, including women whose last menstrual period was less
than one year prior to screening, unable or unwilling to use adequate contraception
from study start to one year after the last dose of protocol therapy. Adequate
contraception is defined as hormonal birth control, intrauterine device, double
barrier method or total abstinence.

15. Male subjects unable or unwilling to use adequate contraception methods from study
start to one year after the last dose of protocol therapy