Phase II Study on Activity and Tolerability of Intralesional Rituximab in Patients With Relapsed or Refractory CD20+ Indolent Lymphomas of Conjunctiva; Activity of Supplemental Autologous Serum in Patients Not Responsive to Rituximab Alone
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- assessment of safety
研究概览
简要总结
Phase II, monocentric, open label study to assess safety and activity of intralesional Rituximab for the treatment of indolent CD20+ lymphoma of conjunctiva.
详细描述
Preliminary data suggest intralesional rituximab is able to revert resistance to systemic rituximab in patients with CD20+ indolent lymphoma of the conjunctiva, and the addition of autologous serum seems to exhibit a synergistic effect on tumor regression. These two main aspects will be assessed in this trial.
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
- •histological diagnosis of CD20+ B cell lymphoma subtypes: marginal zone lymphoma, grade 1-2 follicular lymphoma, plasmocytic lymphoma, small lymphocyte lymphoma
- •conjunctival localization alone (1EA stage; mono- or bilateral)
- •at least one measurable lesion
- •age >/= 18 years
- •ECOG-PS </=3
- •HIV 1-2 negativity
- •at least one previous treatment (antibiotic or rituximab)
排除标准
- •concomitant conventional (chemo-, radiation, immuno-), experimental (antibiotic) or corticosteroid anticancer therapy
- •known allergy to rituximab
- •systemic symptoms
- •concurrent diagnosis of pemphigus
- •postsurgical conjunctival scars
研究组 & 干预措施
intralesional rituximab
干预措施: intralesional rituximab (Drug)
intralesional rituximab
干预措施: supplemental autologous serum (Biological)
结局指标
主要结局
assessment of safety
时间窗: During experimental treatment (within 7 months from trial registration)
assessment of safety of intralesional rituximab in terms of incidence of \>/= G4 adverse events during the experimental treatment
次要结局
- assessment of activity(at the end of experimental treatment (at 7th month from trial registration))
研究者
Andres J. M. Ferreri
MD
IRCCS San Raffaele