A Phase II, Single-Arm, Open-Label Study of the Safety, Pharmacokinetics, and Efficacy of Multiple Doses of Apomab Administered Intravenously in Combination With Rituximab in Patients With Follicular, CD20-Positive B-Cell Non-Hodgkin's Lymphoma That Has Progressed Following Previous Rituximab Therapy

Genentech, Inc0 个研究点目标入组 50 人开始时间: 2008年11月5日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•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.

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