CTRI/2017/12/010935已完成3 期
A Randomized, Double-blind Study Evaluating the Efficacy, Safety andImmunogenicity of ABP 798 Compared with Rituximab in Subjects with CD20 Positive B-cell Non-Hodgkin Lymphoma (NHL)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen Inc
- 入组人数
- 257
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Histologically confirmed (by lymph node or extranodal region biopsy), Grade 1, 2, or 3a follicular B-cell NHL expressing CD20 within 12 months before randomization
- •2. Stage 2, 3, or 4 (per Cotswoldâ??s Modification of Ann Arbor Staging System
- •3. Low tumor burden based on the GELF Criteria
- •a.largest nodal or extranodal mass <= 7 cm
- •b. no more than 3 nodal sites with diameter > 3 cm
- •c.no splenomegaly > 16 cm by CT scan and no symptomatic splenomegaly
- •d. no significant pleural or peritoneal serous effusions by CT
- •e.lactate dehydrogenase <= upper limit of normal (ULN)m before any study specific procedures
- •f. no B symptoms (night sweats, fever [temperature > 38°C], weight loss > 10% in the previous 6 months)
- •4. Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1 with measurable disease (per International Working Group)
- •a. subjects must have a baseline scan (computed tomography [CT]) of the neck (if palpable lymph node > 1.0 cm), chest, abdomen, and pelvis to assess disease burden within 6 weeks before randomization
- •b. subjects must have had a baseline bone marrow biopsy within 12 months before randomization. Previously confirmed positive bone marrow involvement does not need to be repeated for purposes of screening.
- •5. Blood counts:
- •a.absolute neutrophil count (ANC) >= 1.5 x 109/L (1,500/μL)
- •b. lymphocytes < 1.5 x the ULN
- •c.platelets >= 100 x 109/L (100,000/μL)
- •d. hemoglobin >= 10.0 g/dL
- •6. Adequate hepatic function as defined by:
- •a.total bilirubin < 1.5 x the ULN
- •b. aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2 x ULN
- •c. Subjects with an elevated unconjugated bilirubin will be eligible if hepatic enzymes and function are otherwise within normal limits and there is no evidence of hemolysis.
- •7. Adequate renal function as defined by creatinine < 1.5 x ULN or estimated creatinine clearance >= 50 mL/min calculated by the Cockcroft-Gault method
- •8. Subjects must sign an IRB-approved informed consent form before any study specific procedures.
排除标准
- •1.Diffuse large cell component and/or Grade 3b follicular NHL
- •2. History or known presence of central nervous system metastases
- •3. Palliative radiotherapy within 3 months before randomization
- •4. Malignancy other than NHL within 5 years (except treated in-situ cervical cancer, or
- •squamous or basal cell carcinoma of the skin)
- •5. Major surgical procedure within 4 weeks before randomization or planned major surgical
- •procedure during the treatment phase
- •6. Any of the following in the 6 months before randomization:
- •clinically significant cardiovascular disease (including myocardial infarction, unstable
- •angina, symptomatic congestive heart failure [New York Heart Association
- •>= Class III], serious uncontrolled cardiac arrhythmia); peripheral vascular disease,
- •cerebrovascular accident, or transient ischemic attack
- •7. Medically uncontrolled hypertension or systolic blood pressure > 160 mmHg or diastolic
- •blood pressure > 100 mmHg
- •8. Known active or history of active tuberculosis (TB)
- •9. Positive for hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C virus
- •antibody at screening
- •10. Known to be human immunodeficiency virus positive
- •11. Recent infection requiring a course of systemic anti-infective agents that was completed
- •<= 7 days before randomization (with the exception of uncomplicated urinary tract
- •12. Other investigational procedures that can impact the study data, results, or patient
- •safety while participating in this study are excluded; participation in observational
- •studies is allowed.
- •13. Subject is currently enrolled in or has not yet completed at least 30 days or 5 half-lives
- •(whichever is longer) since ending other investigational device or drug study(s), including
- •vaccines, or subject is receiving other investigational agent(s)
- •14. Previous use of either commercially available or investigational chemotherapy, biological,
- •or immunological therapy for NHL (including rituximab or biosimilar rituximab, or other
- •anti-CD20 treatments)
- •15. Systemic corticosteroid use within 3 months before randomization (inhaled are
- •16. Live vaccines within 28 days prior to the first dose of IP
- •17. History of neurologic symptoms suggestive of central nervous system demyelinating
- •18. Woman of childbearing potential who is pregnant or is breastfeeding
- •19. Woman of childbearing potential who does not consent to use highly effective methods of
- •birth control (eg, true abstinence, sterilization, birth control pills, Depo Provera injections,
- •or contraceptive implants) during treatment and for an additional 12 months after the last
- •administration of the protocol specified-treatment
- •20. Man with a partner of childbearing potential who does not consent to use highly effective
- •methods of birth control (eg, true abstinence, vasectomy, or a condom in combination
- •with hormonal birth control or barrier methods used by the woman) during treatment and
- •for an additional 12 months after the last administration of the protocol specified
- •21. Subject has known sensitivity to any of the products to be administered during the study,
- •including mammalian cell derived drug products
- •22. Subject p
研究者
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