A Randomized, Double-Blind Study Evaluating the Efficacy, Safety and Immunogenicity 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
- 入组人数
- 256
- 试验地点
- 99
- 主要终点
- Percentage of Participants Who Responded (Overall Response Rate - ORR) by Week 28 Based on Independent Central Assessment of Disease
研究概览
简要总结
This was a randomized, double-blind, active-controlled, multiple-dose, clinical similarity study to evaluate the efficacy, pharmacokinetics, pharmacodynamics, safety, tolerability and immunogenicity of ABP 798 compared with rituximab in subjects with grade 1, 2, or 3a follicular B-cell NHL and low tumor burden.
Subjects were randomized in a 1:1 ratio to receive a 375 mg/m^2 intravenous infusion of either ABP 798 or rituximab once weekly for 4 weeks followed by dosing at weeks 12 and 20.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females 18 years of age and older
- •Histological confirmed (by lymph node or extranodal region biopsy), Grade 1, 2, or 3a follicular B-cell NHL expressing CD20 within 12 months before randomization
- •Stage 2, 3, or 4 (per Cotswold's Modification of Ann Arbor Staging System) with measurable disease (per International Working Group)
- •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
- •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.
- •Low tumor burden based on the Groupe d'Etudes des Lymphomes Folliculaires (GELF) criteria
- •largest nodal or extranodal mass ≤ 7 cm
- •no more than 3 nodal sites with diameter > 3 cm
- •no splenomegaly > 16cm by CT scan and no symptomatic splenomegaly
- •no significant pleural or peritoneal serous effusions by CT
- •lactate dehydrogenase ≤ upper limit of normal (ULN)
- •no B symptoms (night sweats, fever [temperature > 38°C], weight loss > 10% in the previous 6 months)
排除标准
- •Diffuse large cell component and/or Grade 3b follicular NHL
- •History or known presence of central nervous system metastases
- •Malignancy other than NHL within 5 years (except treated in-situ cervical cancer, or squamous or basal cell carcinoma of the skin)
- •Recent infection requiring a course of systemic anti-infective agents that was completed ≤ 7 days before randomization (with the exception of uncomplicated urinary tract infection)
- •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.
- •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)
- •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)
- •Systemic corticosteroid use within 3 months before randomization (inhaled are allowable)
结局指标
主要结局
Percentage of Participants Who Responded (Overall Response Rate - ORR) by Week 28 Based on Independent Central Assessment of Disease
时间窗: Post treatment up to Week 28
Overall response within the first treatment cycle was assessed according to International Working Group - Non-Hodgkin Lymphoma criteria (IWG-NHL criteria \[Cheson et al, 1999\]) by a central reader. Response was evaluated using computerized tomography (CT) scans and positron emission tomography (PET) (to assess nodal disease/organ enlargement), and bone marrow biopsy (to assess bone marrow infiltration). ORR was the percentage of participants with a best overall response of complete response (CR), unconfirmed complete response (CRu) or partial response (PR). Participants that do not meet the criteria for response were considered non-responders. CR was defined as no evidence of disease. CRu showed nodes in the original sum of the products (SPD) regressed by \>75% and/or indeterminate bone marrow results. PR was a ≥ 50% decrease in SPD of the six largest dominant nodes; \>=50% decrease in liver and spleen nodes, and no increase in size of other nodes nor any new sites of disease.
次要结局
- Total Immunoglobulin G (IgG) Results by Visit(Baseline (Day 1), Day 8 (Week 2), Weeks 3, 4, 28)
- Participants' Progression-Free Survival (PFS) Status Based on the Independent Central Assessment of Disease(Day 1 up to Week 28)
- Percentage of Participants Who Responded (Overall Response Rate - ORR) at Week 12 Based on Independent Central Assessment of Disease(Week 12)
- Pharmacokinetic Serum Concentrations by Visit(Weeks 2, 3, 4, 12 and 20)
- Percentage of Participants With Complete Depletion of Clusters of Differentiation 19-Positive (CD19+) Cell Count From Baseline to Day 8(Baseline (Day 1), Study Day 8)
- Total Immunoglobulin M (IgM) Results by Visit(Baseline (Day 1), Day 8 (Week 2), Weeks 3, 4, 28)
- Participants With Treatment-Emergent Adverse Events(Day 1 (post treatment) to Week 28)
- Percentage of Participants With Treatment-emergent Adverse Events of Interest (AEOIs)(Day 1 (post treatment) to Week 28)
- Number of Participants Who Developed Anti-drug Antibodies(Baseline (Day 1), Weeks 12, 20 and 28)
- Percentage of Participants Who Survived -- Overall Survival (OS)(Day 1 up to Week 28)