Phase I/II Study of CAMPATH in Patients With Relapsing or Refractory Non-Hodgkin’s Lymphoma

Inclusion Criteria: Patients must have:

Pathologically confirmed diagnosis of relapsing or refractory non-Hodgkin's lymphoma that has failed conventional therapy.
Measurable disease (lesions that can be accurately measured by CT scan and a greatest transverse diameter larger or equal to 1 cm or palpable lesions that both diameters larger or equal to 2 cm).
Life expectancy of at least 12 weeks. - World Health Organization (WHO) performance status (PS) of 0, 1, or 2.
Adequate marrow and organ function (details are listed in the protocol).
Female patients with childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment. Male and female 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.

Exclusion Criteria: Patients must not have:

Prior autologous bone marrow or stem cell transplant within 6 months of study entry.
A history of prior allogeneic bone marrow transplant or organ transplant.
Previously untreated non-Hodgkin's lymphoma.
Previously treated with CAMPATH.
Patients with bulky disease, ie any single mass > 7.5cm.
Prior radiotherapy to the only site of measurable disease.
Medical condition requiring chronic use of oral, high-dose corticosteroids.
Autoimmune thrombocytopenia.
Use of investigational agents within previous 30 days or any anti-cancer therapy within the previous 3 weeks. Patients must have recovered from all acute toxicities of any prior therapy.
Past history of anaphylaxis following exposure to humanized monoclonal antibodies.
Active, uncontrolled infection, including human immunodeficiency virus (HIV) positive.
Active secondary malignancy.
Active central nervous system (CNS) involvement with NHL.
Pregnant or lactating women. Male or female patients who do not agree to use effective contraceptive method(s) during the study.
Any significant concurrent disease or illness that would, in the opinion of the investigator, compromise patient safety or compliance, or interfere with the interpretation of study results.