A Phase II Trial of Extended Induction Epratuzumab (Anti-CD22 Monoclonal Antibody) (CALGB IND #XXXXX) Plus Rituximab in Previously Untreated Follicular Non-Hodgkin's Lymphoma (NHL)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 43
- 主要终点
- Number of Participants With Overall Response
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as epratuzumab and rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving epratuzumab and rituximab together may be more effective in treating follicular non-Hodgkin lymphoma.
PURPOSE: This phase II trial is studying how well giving epratuzumab together with rituximab works in treating patients with previously untreated follicular non-Hodgkin lymphoma.
详细描述
OBJECTIVES:
Primary
- To determine the response rate (overall and complete) after extended induction therapy comprising epratuzumab and rituximab in patients with previously untreated CD20+ follicular non-Hodgkin lymphoma (NHL).
- To determine the time to progression after extended induction therapy comprising epratuzumab and rituximab in patients with previously untreated CD20+ follicular NHL.
Secondary
- To determine the toxicity profile of epratuzumab and rituximab in patients with previously untreated CD20+ follicular NHL.
- To establish whether the therapeutic effects of the combination of epratuzumab and rituximab are sufficiently promising to warrant evaluation in a subsequent randomized trial (in comparison to rituximab alone).
- To determine the relationship between the change in fludeoxyglucose F 18 uptake early after epratuzumab and rituximab treatment with response rate and time to progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •DISEASE CHARACTERISTICS:
- •Histologically* confirmed follicular non-Hodgkin lymphoma (NHL)
- •Previously untreated disease
- •WHO classification grade 1, 2, or 3a (> 15 centroblasts per high power field with centrocytes present) that is stage III, IV, or bulky (i.e., single mass ≥ 7 cm in any unidimensional measurement) stage II disease NOTE: *Bone marrow biopsies as the sole means of diagnosis are not acceptable, but they may be submitted in conjunction with nodal biopsies; fine-needle aspirates are not acceptable for diagnosis
- •Confirmed CD20 antigen expression by flow cytometry or immunohistochemistry
- •Measurable disease by physical examination or imaging studies
- •Any tumor mass > 1 cm is acceptable
- •No nonmeasurable disease only, including any of the following:
- •Bone lesions
- •Pleural/pericardial effusion
- •Lymphangitis cutis/pulmonis
- •Bone marrow (involvement by NHL should be noted)
- •No known CNS involvement by lymphoma
- •Required to participate in companion FDG-PET imaging study CALGB 580701
- •PATIENT CHARACTERISTICS:
- •ECOG performance status ≤ 2
- •Absolute neutrophil count ≥ 1,000/μL
- •Platelet count ≥ 50,000/μL
- •Patients with HIV infection are eligible provided they meet the following criteria:
- •No evidence of coinfection with hepatitis B or C
- •CD4+ cell count ≥ 400/mm^3
- •No evidence of resistant strains of HIV
- •If not on anti-HIV therapy, HIV viral load < 10,000 copies HIV RNA/mL
- •If on anti-HIV therapy, HIV viral load < 50 copies HIV RNA/mL
- •No history of AIDS-defining conditions
- •Not pregnant or nursing
- •Fertile patients must use effective contraception during and for 3 months after completion of study therapy
- •No known Human Anti-Chimeric Antibody (HACA)-positivity
- •PRIOR CONCURRENT THERAPY:
- •No prior therapy for NHL including chemotherapy, radiotherapy, or immunotherapy (e.g., monoclonal antibody-based therapy)
- •More than 2 weeks since prior corticosteroids except for maintenance therapy for non-malignant disease
- •No concurrent dexamethasone or other steroids as antiemetics except for the following circumstances:
- •Treatment of acute infusion reactions according to institutional procedures
- •No concurrent hormonal therapy except steroids for adrenal failure OR hormones for non-disease-related conditions (e.g., insulin for diabetes)
- •No other concurrent chemotherapeutic agents
排除标准
- 未提供
研究组 & 干预措施
Epratuzumab Plus Rituximab
Induction Therapy (Month 1): Epratuzumab 360 mg/m^2 by IV days 1, 8, 15 & 22; Rituximab 375 mg/m^2 by IV day 3, 8, 15 & 22
Extended Induction (Weeks 12, 20, 28 & 36) Epratuzumab 360 mg/m^2 by IV weeks 12, 20, 28 & 36; Rituximab 375 mg/m^2 by IV weeks 12, 20, 28 & 36
干预措施: rituximab (Biological)
Epratuzumab Plus Rituximab
Induction Therapy (Month 1): Epratuzumab 360 mg/m^2 by IV days 1, 8, 15 & 22; Rituximab 375 mg/m^2 by IV day 3, 8, 15 & 22
Extended Induction (Weeks 12, 20, 28 & 36) Epratuzumab 360 mg/m^2 by IV weeks 12, 20, 28 & 36; Rituximab 375 mg/m^2 by IV weeks 12, 20, 28 & 36
干预措施: epratuzumab (Biological)
结局指标
主要结局
Number of Participants With Overall Response
时间窗: 12 months
Overall response is defined as achievement of a complete response (CR) or partial response (PR) as defined by the Revised Response Criteria for Malignant Lymphoma. CR: complete disappearance of all detectable disease PR: \>=50% decrease in the sum of the product of diameters of indicator lesions
次要结局
- Progression Free Survival(Duration of study (up to 10 years))