Subcutaneous Alemtuzumab (CAMPATH®, MabCampath®) in Relapsed/Refractory B-Cell Chronic Lymphocytic Leukemia
Subcutaneous Alemtuzumab (CAMPATH®, MabCampath®) in Relapsed/Refractory B-Cell Chronic Lymphocytic Leukemia
This is a Phase II, open-label, prospective, multicenter study to evaluate the efficacy and
 safety of subcutaneously administered alemtuzumab (CAMPATH, MabCampath) as therapy for
 patients with relapsed or refractory B-CLL who have been previously treated.
Inclusion Criteria:

 -  A diagnosis of B-cell chronic lymphocytic leukemia (B-CLL); according to the National
 Cancer Institute Working Group (NCI WG) Criteria.

 -  World Health Organization (WHO) performance status of 0, 1, or 2.

 -  Life expectancy ≥ 12 weeks.

 -  Previous therapy with at least one but no more than 5 regimens (single agent or
 combination regimen). One therapy regimen is defined as consecutive, contiguous cycles
 of the same drug(s) with no treatment interruptions lasting > 3 months.

 -  Patient requires treatment for CLL per the following criteria: -Rai stage III or IV;
 -Rai stage 0-II with at least one of the following - evidence of progressive marrow
 failure as manifested by the development of, or worsening of, anemia and/or
 thrombocytopenia; Massive (i.e. greater than 6 cm below the left costal margin) or
 progressive splenomegaly; Progressive lymphocytosis with an increase of greater than
 50% over a 2-month period or an anticipated doubling time of less than 6 months;
 Lymphocyte count > 100*10^9/L; B symptoms.

 -  More than 3 weeks since prior chemotherapy. Patient must have recovered from the acute
 side effects incurred as a result of previous therapy.

 -  More than 3 weeks since using investigational agents. Patient must have recovered from
 the acute side effects incurred as a result of previous therapy.

 -  Serum creatinine and conjugated (direct) bilirubin less than or equal to 2 times the
 institutional upper limit of normal (ULN) unless secondary to direct infiltration of
 the liver with CLL.

 -  Female patients with childbearing potential must have a negative pregnancy test (serum
 or urine) within 2 weeks of first dose of study drug(s). All patients must agree to
 use an effective contraceptive method while on study treatment, if appropriate, and
 for a minimum of 6 months following study therapy.

 -  Signed, written informed consent (in the US, includes The Health Insurance Portability
 and Accountability Act of 1996 (HIPAA) authorization)

 Exclusion Criteria:

 -  Positive Coombs test and evidence of active hemolysis.

 -  Platelet count less than 50*10^9/L without splenomegaly.

 -  History of anaphylaxis following exposure to rat or mouse derived CDR-grafted
 humanized monoclonal antibodies.

 -  Previously treated with CAMPATH.

 -  Previous bone marrow transplant.

 -  Known central nervous system (CNS) involvement with B-CLL

 -  Active infection, including human immunodeficiency virus (HIV) positive.

 -  Active second malignancy.

 -  Recent documented history (within 2 years) of active tuberculosis (TB), current active
 TB infection, currently receiving anti-tuberculous medication (e.g., INH, rifampin,
 streptomycin, pyrazinamide, or others).

 -  Active hepatitis or a history of prior viral hepatitis B or hepatitis C, or positive
 hepatitis B serologies. Patients with a positive hepatitis B surface antibody (HBsAb)
 test with a documented history of prior hepatitis B immunization are eligible as long
 as other criteria are met (i.e. negative tests for: hepatitis B surface antigen
 (HBsAg), hepatitis B core antibody (HBcAb) and hepatitis C virus antibody (HCVAb)).

 -  Other severe, concurrent diseases (e.g., cardiac or pulmonary disease), mental
 disorders, or major organ malfunction (liver, kidney) that could interfere with the
 patient ability to participate in the study.

 -  Pregnant or nursing women.

 -  Cytomegalovirus (CMV) positive by polymerase chain reaction (PCR) (above the level of
 detection). A patient that is PCR positive will require treatment to reduce the viral
 load to a non-detectable level; but such a patient may be considered for study entry
 once the infection has been treated.

 -  Medical condition requiring chronic use of oral corticosteroids at a dose higher than
 physiologic replacement.