A Phase II Study of Ofatumumab-Based Induction Chemoimmunotheraphy Followed by Consolidation Ofatumumab Immunotherapy in Previously Untreated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Inclusion Criteria

- INCLUSION CRITERIA:

Histologically confirmed CLL or SLL as defined by the following:

- B-lymphocytosis greater than 5000 cells/micro L (may be less than 5000 cells/micro L
if lymphadenopathy is present with histologic confirmation of lymph node involvement
by SLL).

- Immunophenotypic profile consistent with CLL as demonstrated by flow cytometry

- Appropriate immunophonotype (CD5/19/23+)

- Clonality of lymphocytosis confirmed by flow cytometry

- large lymphocytes less than 55 % of blood lymphocytes

Active disease as defined by at least one of the following:

- Weight loss greater than or equal to10 percent within the previous 6 months

- Extreme fatigue

- Fevers of greater than 100.5 degree F for greater than or equal to 2 weeks without
evidence of infection

- Night sweats for more than one month without evidence of infection

- Evidence of progressive marrow failure as manifested by the development of, or
worsening of, anemia and/or thrombocytopenia

- Massive or progressive splenomegaly

- Massive nodes or clusters or progressive lymphadenopathy

- Progressive lymphocytosis with an increase of greater than 50% over a 2 month period,
or an anticipated doubling time of less than 6 months 0

Measurable disease (defined as two dimensional disease on imaging or quantifiable leukemic
disease).

Ages 18 and over.

EXCLUSION CRITERIA:

Prior monoclonal antibody therapy with agents having anti-CLL activity

Prior cytotoxic chemotherapy with agents having anti-CLL activity

Transformed CLL

Active autoimmune hemolytic anemia or thrombocytopenia

Any medical condition that requires the chronic use of corticosteroids

Active or latent Hepatitis B infection

HIV infection

Severe chronic obstructive pulmonary disease, severe cardiac disease, or other
uncontrolled medical condition that would, in the opinion of the principal investigator,
place the subject at an unreasonable risk of life-threatening adverse events due to
chemoimmunotherapy

ECOG performance status 3 or worse

Creatinine greater than or equal to 2 mg/dL or creatinine clearance less than or equal to
30 mL/min

Bilirubin greater than or equal to 2 mg/dL or active hepatic or biliary disease (with
exception of patients with Gilbert's syndrome, asymptomatic gallstones, or stable chronic
liver disease per investigator assessment)

Female patients: Current pregnancy or unwilling to take oral contraceptives or refrain
from pregnancy if of childbearing potential or currently breastfeeding. Male patients who
are unwilling to follow the contraception requirements described in this protocol.

Psychiatric illness/social situations that would limit the patient's ability to tolerate
and/or comply with study requirements.

Unable to understand the investigational nature of the study or give informed consent.