Non-Hodgkin's Lymphoma
Conditions
Keywords
Non-Hodgkin's Lymphoma, NHL, CAMPATH, alemtuzumab
Brief 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.
Detailed description
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.
Interventions
Sponsors
Genzyme, a Sanofi Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Countries
United States
Outcome results
None listed