NCT01820910已完成2 期
International Prospective Phase 2 Trial Addressing the Efficacy of First-line Chlamydophila Psittaci-eradicating Therapy With Protracted Administration of Doxycycline Followed by Eradication Monitoring and Antibiotic Re-treatment at Infection Re-occurrence in Patients With Newly Diagnosed Ocular Adnexal Marginal Zone Lymphoma (OAMZL)
International Extranodal Lymphoma Study Group (IELSG)8 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2013年3月19日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 8
- 主要终点
- progression-free survival (PFS)
研究概览
简要总结
Objective of this trial is to establish the efficacy of an upfront targeted therapy consisting of Chlamydophila psittaci (Cp)-eradicating therapy with prolonged administration of doxycycline followed by eradication monitoring and antibiotic re-treatment at infection re-occurrence in patients with newly diagnosed ocular adnexae marginal zone lymphoma The primary endpoint is the 2-year progression-free survival (PFS) of patients with newly diagnosed stage-IE lymphoma treated with the experimental strategy.
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 marginal zone lymphoma of the ocular adnexae (OAMZL)
- •Single or bilateral lesion (stage IE) localised to the ocular adnexae (conjunctiva, lachrymal gland or sac, orbit soft tissue, eyelid)
- •Absence of B symptoms
- •Previously untreated patients
- •No systemic antibiotic therapy in the last three months before enrolment
- •Age >18 years
- •ECOG PS 0-2
- •Negative HIV, HBV and HCV serology
- •Adequate bone marrow, renal, and hepatic function
- •No previous or concurrent malignancies with the exception of surgically cured carcinoma in situ of the cervix, carcinoma of the skin or other cancers without evidence of disease at least from 5 years
- •Absence of any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- •Sexually active patients of childbearing potential must implement adequate contraceptive measures during study participation
- •No concurrent treatment with other experimental drugs
- •Patient-signed informed consent obtained before registration
排除标准
- •Pregnant or lactating women
- •Known allergy to tetracycline
- •Patients unwilling to comply with the requirements of follow-up
- •Myasthenia gravis (tetracycline can exacerbate muscle weakness)
- •Systemic lupus erythematous (tetracycline can exacerbate this condition)
- •Patients with large or rapidly enlarging tumors requiring immediate radiotherapy
研究组 & 干预措施
Doxycycline
Experimental
干预措施: Doxycycline (Drug)
结局指标
主要结局
progression-free survival (PFS)
时间窗: 2-year from start of treatment
from the date of the start of treatment to relapse, progression or death, or to the last date of follow-up
次要结局
未报告次要终点
研究者
研究点 (8)
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