Ofatumumab + Chlorambucil vs Chlorambucil Monotherapy in Previously Untreated Patients With Chronic Lymphocytic Leukemia

Chlorambucil, is currently approved for treatment of frontline chronic lymphocytic leukemia,
especially, but not limited to the ailing and elderly patient population. Several other more
aggressive treatment options are available (e.g. fludarabine), however they are not suitable
for all CLL patients, especially the ailing and elderly, due to greater toxicity. Ofatumumab
is effective with low toxicity. The addition of ofatumumab to chlorambucil offers potentially
a more effective therapy, with limited toxicity. The objective of this study is to evaluate
progression-free survival (PFS), overall response and overall survival in subjects with
previously untreated CLL with ofatumumab added to chlorambucil versus chlorambucil.

Inclusion Criteria:

- confirmed CLL diagnosis and active CLL requiring treatment

- considered inappropriate for fludarabine-based therapy

- not been treated for CLL before

- fully active at a minimum or fully capable of selfcare and up and about more than 50%
of waking hours

- age 18yrs or older

- signed written informed consent

Exclusion Criteria:

- prior CLL therapy

- abnormal/inadequate blood values, liver, and kidney function

- certain heart problems, active or chronic infections, serious significant diseases,
AIHA requiring treatment, other current cancer or within last 5 years

- CLL transformation

- CLL central nervous system involvement

- current participation in other clinical study

- inability to comply with the protocol activities

- lactating or pregnant women or female patients of child-bearing potential (or male
patients with such partners) not willing to use adequate contraception