This is a Phase III, open-label, multicenter, randomized, comparative study of Campath versus chlorambucil as front line therapy in patients with progressive B-Cell Lymphocytic Leukemia (B-CLL). Eligible patients must have previously untreated, Rai stage I-IV disease, and be experiencing progression of their B-CLL requiring treatment. Patients who meet all eligibility criteria may be randomized on a 1:1 basis to receive either Campath or chlorambucil. An estimated 284 patients (142 per treatment arm) from approximately 40 or more investigational sites will be randomized to one of the two treatment arms.

Condition	Treatment or Intervention	Phase
B-cell Chronic Lymphocytic Leukemia	Drug: alemtuzumab	Phase III

Further Study Details: 

Expected Total Enrollment:  284

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

Patients must meet the following:

• Histopathologically confirmed diagnosis of B-CLL with CD5, CD19, or CD23 positive clone.
• Rai Stage I through IV disease with evidence of progression (specific factors detailed in Inclusion Criteria of the protocol).
• Received no previous chemotherapy for B-CLL.
• Life expectancy of at least 12 weeks.
• WHO performance status of 0, 1, or 2.
• Serum creatinine less or equal to 2.0 times the institutional upper limit of normal (ULN) value.
• Adequate liver function as indicated by a total bilirubin, AST, and ALT less or equal to 2 times the institutional ULN value, unless directly attributable to the disease.
• Female patients must have a negative serum pregnancy test within 2 weeks prior to randomization, and both men and women must agree to use an effective contraceptive method while on study and for a minimum of 6 months after study therapy.
• Signed, written informed consent.
• 18 years of age or older.

Exclusion Criteria:

Patients with or who meet the following will be excluded from study admission:

• ANC less than 500 million per liter or platelet count less than 10 billion per liter.
• Medical condition requiring chronic use of oral corticosteriods.
• Autoimmune thrombocytopenia.
• Previous bone marrow transplant.
• Use of investigational agents within previous 30 days.
• Positive for HIV.
• Past history of anaphylaxis following exposure to rat or mouse-derived complementary determining region (CDR) grafted humanized monoclonal antibodies.
• Active infection.
• Serious cardiac or pulmonary disease that could interfere with their ability to participate in the study.
• Recent documented (with in 2 years) of active tuberculosis (TB), current active TB, or currently receiving anti-tuberculosis medication.
• Active secondary malignancy.
• Central nervous system involvement with CLL.
• Positive quantitative CMV by PCR assay (using the laboratory normal ranges).
• A diagnosis of mantle cell lymphoma.
• Other severe, concurrent diseases or mental disorders.
• Pregnant or lactating women.

Arizona
      Tucson,  Arizona,  United States
Arkansas
      Little Rock,  Arkansas,  United States
Florida
      Tampa,  Florida,  United States
      Ft. Myers,  Florida,  United States
Illinois
      Hines,  Illinois,  United States
Kentucky
      Louisville,  Kentucky,  United States
      Paducah,  Kentucky,  United States
Louisiana
      Lafayette,  Louisiana,  United States
Mississippi
      Tupelo,  Mississippi,  United States
      Jackson,  Mississippi,  United States
Missouri
      Jefferson City,  Missouri,  United States
      Kansas City,  Missouri,  United States
Montana
      Billings,  Montana,  United States
Nebraska
      Omaha,  Nebraska,  United States
New York
      New Hyde Park,  New York,  United States
      Rochester,  New York,  United States
North Carolina
      Durham,  North Carolina,  United States
South Dakota
      Sioux Falls,  South Dakota,  United States
Texas
      San Antonio,  Texas,  United States
Virginia
      Norfolk,  Virginia,  United States

Study ID Numbers:  CAM307
Record last reviewed:  April 2005
Last Updated:  April 5, 2005
Record first received:  October 1, 2002
ClinicalTrials.gov Identifier:  NCT00046683
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08