rituximab plus campath in patients with relapsed/refractory low-grade or follicular, cd20-positive, b-cell nhl

Conditions: Non-Hodgkin's Lymphoma

Summary: the purpose of this study is to determine the optimal dose of subcutaneous campath when used in combination with rituximab for patients with relapsing or refractory, low-grade or follicular, cd-20-positive, b-cell non-hodgkin's lymphoma. safety will be the primary objective of phase i, while the primary objective of phase ii will be to determine overall response.

this study is being conducted in 2 parts. phase i will involve dose escalation of subcutaneous campath (sq) given 3 times per week in combination with weekly doses of rituximab (375mg/m2) for a maximum of 8 weeks in order to determine the maximum tolerated dose (mtd). in phase ii patients will be treated with sq campath at the mtd plus weekly rituximab (375mg/m2)for a maximum of 8 weeks with primary objective of defining overall response (or) to this combination.

Eligibility criteria:
inclusion criteria: * for the phase i portion of the study, patients must have pathologically confirmed diagnosis of low-grade or follicular, cd20-positive, b-cell, non-hodgkin's lymphoma that has relapsed or is refractory. for the phase ii portion of the study, patients must have a pathologically confirmed diagnosis of low-grade or follicular, cd20-positive, b-cell, non-hodgkin's lymphoma (follicular, predominantly small cleaved or follicular, mixed small cleaved and large cell, international working formulation classification b or c or real classification follicular center grade 1,2) that has relapsed or is refractory. * previously treated with at least one anti-cancer regimen for nhl * measurable disease (lesions that can be accurately measured in 2 dimensions by ct scan with a greatest transverse diameter of \>/= to 2cm or palpable lesions with both diameters of 2cm or more) * life expectancy of at least 12 weeks * who performance status or 0 or 1 * adequate marrow and organ function (as defined in the protocol) * completed major surgery, radiotherapy, chemotherapy, immunotherapy or biotherapy/targeted therapies at least 4 weeks prior to study entry (6 weeks if treated with a nitrosourea or mitomycin). patients must have recovered from all prior treatment toxicity to grade 1 or less, exclusive of alopecia. exclusion criteria: * prior combination therapy with rituximab and campath; prior therapy with either agent alone is permitted * a history of a t-cell lymphoma * known aids-related hiv-positive lymphoma * for the phase ii portion of the study (once mtd has been determined), bulky disease, ie, any single mass \>10cm or circulating malignant cells of 25,000/ul or more * prior autologous bone marrow or stem cell transplant within 6 months of study entry * prior allogeneic bone marrow transplant or organ transplant * prior radiotherapy to the only site of measurable disease * medical condition requiring chronic use of oral, high-dose corticosteroids * use of investigational agents within 30 days of study enrollment * past history of anaphylaxis following exposure to humanized monoclonal antibodies * known, active, infection, including hiv positive * diagnosis of another malignancy within the previous five (5) years, unless the probability of recurrence of the prior malignancy is \< 5%. patients with curatively treated early stage squamous cell carcinoma of the skin, basal cell carcinoma of the skin, cervical intraepithelial neoplasia (cin), and patients with a history of malignant tumor in the past that have been disease-free for at least 5 years * active central nervous system (cns) involvement with lymphoma * pregnant or nursing women * 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 * active hepatitis or a history of prior viral hepatitis b or c, or positive hepatitis b serologies without prior immunization

Keywords: non-hodgkin's lymphoma nhl campath alemtuzumab