A Study of Apomab in Combination With Rituximab in Patients With Non-Hodgkin's Lymphoma That Has Progressed Following Previous Rituximab Therapy
- Conditions
- on-Hodgkin's Lymphoma (NHL)Cancer - Lymphoma (non Hodgkin's lymphoma) - Low grade lymphomaNon-Hodgkin's Lymphoma (NHL)
- Registration Number
- ACTRN12608000554369
- Lead Sponsor
- Genentech, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 50
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective response based on the results of radiographic studies and pertinent clinical data as determined using modified International Working Group (IWG) Criteria. Tumors will be evaluated for response and disease progression based on the size and quantity of the lesions as compared to baseline exams.[8 months]
- Secondary Outcome Measures
Name Time Method Progression-free survival, as determined by independent review facility; Overall survival, defined as the time from first Apomab exposure until death from any cause.[Follow-up information will be collected via telephone calls and/or clinic visits every 3 months until death, loss to follow-up, or study termination by Genentech.]