None listed
Conditions
Brief summary
Apomab is a monoclonal antibody, which is a type of protein that is normally made by the immune system to help defend the body from infection and cancer. In preclinical studies Apomab selectively induced programmed cell death, or apoptosis, in cancer cells while sparing normal cells. Apomab is being studied in this clinical trial in combination with Rituximab to evaluate whether it is safe for patients with follicular NHL and whether it can delay the further spread of follicular NHL.
Interventions
All patients will receive Rituximab once per week for up to 8 weeks in Cycles 1-3. The first dose of Rituximab will be administered between 24 and 120 hours prior to the first dose of Apomab in Cycle 1. In Cycles 2 & 3 on Day 1, Rituximab will be administered directly prior to Apomab, without a rest period between the two treatments. All patients will receive Apomab for a total of six cycles. Each cycle lasts 21 days with a resting period built into each cycle. The length of the resting peri
All patients will receive Rituximab once per week for up to 8 weeks in Cycles 1-3. The first dose of Rituximab will be administered between 24 and 120 hours prior to the first dose of Apomab in Cycle 1. In Cycles 2 & 3 on Day 1, Rituximab will be administered directly prior to Apomab, without a rest period between the two treatments. All patients will receive Apomab for a total of six cycles. Each cycle lasts 21 days with a resting period built into each cycle. The length of the resting period depends on the cycle. The Apomab dose will be based on the patient's body weight at screening. The rituximab dose will be based on the patient's body surface area at screening. Both Rituximab and Apomab are administered intravenously (IV).
Sponsors
Genentech, Inc
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Diagnosis of follicular, CD20-positive B-cell Non-Hodgkin's Lymphoma (NHL). Progression of disease after an objective response or stable disease lasting > 6 months following completion of the most recent rituximab-containing regimen. Measurable disease. Life expectancy of > 3 months. Signed Informed Consent Form.
Exclusion criteria
Grade 3b follicular lymphoma (according to the World Health Organization (WHO) classification) or histologic transformation from follicular lymphoma to aggressive lymphoma. Prior radiotherapy to a lesion(s) that will be used to assess response unless that lesion(s) shows clear evidence of lymphoma progression at baseline. Radiotherapy to a peripheral lesion within 14 days prior to Cycle 1, Day 1 or radiotherapy to a thoracic, abdominal, or pelvic field within 28 days prior to Cycle 1, Day 1. Concurrent systemic corticosteroid therapy. Other invasive malignancies within 3 years prior to first study drug administration except for adequately treated basal or squamous cell skin cancer, in situ carcinoma of the cervix, in situ breast cancer, in situ prostate cancer, limited-stage bladder cancer, or other cancers from which the patient has been disease-free for at least 3 years. History or evidence on physical examination of central nervous system (CNS) disease Prior treatment with agonistic DR4 or DR5 antibodies or APO2L.
Outcome results
None listed