Continuous Infusion of Campath-1H Followed by Subcutaneous Injections in Previously Treated Patients With Chronic Lymphocytic Leukemia
Continuous Infusion of Campath-1H Followed by Subcutaneous Injections in Previously Treated Patients With Chronic Lymphocytic Leukemia
The goal of this clinical research study is to learn if giving CAMPATH-1H first as an
 injection into a vein, then as an injection under the skin can shrink or slow the growth of
 the disease in patients with chronic lymphocytic leukemia (CLL) who have already received
 standard therapy. Another goal is to learn if the side effects related to CAMPATH-1H
 treatment are less severe by giving the drug first as an injection into a vein then as an
 injection under the skin.
The purposes of this trial are:

 1. To evaluate the response rate (CR+PR) to CAMPATH-1H given as continuous infusion
 followed by subcutaneous injection in patients with previously treated CLL who have
 failed fludarabine therapy.

 2. To evaluate whether CAMPATH-1H, given as a continuous infusion followed by subcutaneous
 injections to patients with previously treated CLL will improve tolerability of the
 agent and permit higher doses to be delivered through that route.

 3. To evaluate the pharmacokinetics of CAMPATH-1H when given as a 24 hour continuous
 infusion followed by a subcutaneous injection.
Inclusion Criteria:

 -  Age >= 18 years (CLL does not occur in the pediatric population).

 -  Signed informed consent.

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

 -  Patients with B-CLL who have received fludarabine and are either refractory to
 frontline therapy or have relapsed within six months from receiving fludarabine-based
 therapy. Patients previously treated with Campath-1H are eligible.

 -  Serum creatinine <= 2mg/dL, total bilirubin <= 2mg/dL, and SGPT <= 3x upper limit of
 normal (ULN) unless due to direct infiltration of the liver or kidney with malignant
 cells.

 Exclusion Criteria:

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

 -  Prior chemotherapy, immunotherapy, or hormonal therapy within 2 weeks prior to study
 start. Hormonal replacement therapy is permitted. Prior therapy with monoclonal
 antibodies for at least 4 weeks prior to study start.

 -  Pregnant or nursing women or any patient of childbearing age unwilling to practice an
 acceptable form of contraception.

 -  Patients with history of HIV positivity.

 -  Active secondary malignancy.

 -  Active uncontrolled infection or any major systemic or other illness that would, in
 the opinion of the investigator, interfere with the patient's ability to comply with
 the protocol, compromise patient safety or interfere with the interpretation of study
 results.