Phase II Study of Ibritumomab Tiuxetan (Zevalin®) in Patients With Previously Untreated Marginal Zone Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Overall Rate of Response (ORR) in Participants Receiving Protocol Therapy.
研究概览
简要总结
Zevalin may be an effective therapy for newly diagnosed marginal zone lymphoma (MZL).
详细描述
This phase II study will assess the clinical response rate to Ibritumomab Tiuxetan in patients with untreated nodal, splenic and non-gastric extranodal MZL as well as in antibiotic resistant patients with mucosa-associated lymphoid tissue (MALT) gastric lymphoma.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years old with previously untreated, histologically confirmed Marginal Zone Lymphoma (non-gastric extranodal MZL, splenic MZL and nodal MZL) or gastric MZL that did not respond to antibiotic therapy given up to 6 months prior to enrollment, but not less than 2 months)
- •Measurable and evaluable disease
- •All stages are eligible
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 (Appendix B)
- •Willing and able to provide written informed consent
- •Women of childbearing potential must have a negative pregnancy test at study entry and must agree to use effective contraception while on treatment and for 6 months after treatment
- •Life expectancy of at least 6 months
排除标准
- •Prior chemotherapy, radiation therapy, immunotherapy, systemic corticosteroids, or systemic biologic anticancer therapy before beginning study treatment.
- •≥ 25% lymphoma bone marrow involvement
- •Platelet count < 100,000 cells/mm³
- •Neutrophil count < 1,500 cells/mm³
- •Known history of HIV infection
- •Pregnant or lactating (pregnancy test is required for all female patients of childbearing potential)
- •Woman of childbearing potential or sexually active man unwilling to use adequate contraceptive protection.
- •Physical or mental condition that makes patient unable to complete specified follow-up assessments
研究组 & 干预措施
Zevalin + Rituximab
Ibritumomab Tiuxetan (Zevalin) + Rituximab
干预措施: Rituximab (Drug)
Zevalin + Rituximab
Ibritumomab Tiuxetan (Zevalin) + Rituximab
干预措施: Ibritumomab Tiuxetan (Drug)
结局指标
主要结局
Overall Rate of Response (ORR) in Participants Receiving Protocol Therapy.
时间窗: 12 weeks post-therapy
The overall response rate (ORR) including complete response (CR), complete response unconfirmed (CRu), and partial response (PR) in participants receiving protocol therapy.
次要结局
- Rate of Progression-Free Survival(End of study.)
- 5-Year Rate of Progression-Free Survival (5-Year PFS)(5 Years)
- Overall Survival (OS) Rate(End of Study)
- 5 Year Rate of Overall Survival (5-Year OS)(5 Years)
- Number of Participants With Unacceptable Toxicity.(Up to 12 weeks post-therapy)
研究者
Izidore Lossos
Professor
University of Miami