NCT01010295已完成2 期
A Clinico-pathological Phase II Study With Translational Elements to Investigate the Possible Infective Causes of Non-Hodgkin Lymphoma of the Ocular Adnexae With Particular Reference to Chlamydia Species and the Effects of MALT Lymphoma Treatment With Tetracycline
International Extranodal Lymphoma Study Group (IELSG)6 个研究点 分布在 4 个国家目标入组 54 人开始时间: 2006年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 6
- 主要终点
- response rates
研究概览
简要总结
Patients with mucosa-associated lymphoid tissue (MALT) lymphoma of the ocular adnexae (MLOA) will be eligible for treatment with doxycycline (part A: clinico-pathological study); patients with other types of ocular lymphoma, inflammatory lesions or those ineligible/unwilling for treatment with doxycycline can participate in the only pathologic study (part B).
详细描述
Patients with suspected lymphoma of the ocular adnexae will undergo a diagnostic biopsy in the usual way. If lymphoma is confirmed the patient will undergo a full staging evaluation and entry into either part A or B of the study will then be considered as follows:
- clinico-pathological (part A) for patients with MALT lymphoma of the ocular adnexae (MLOA) and eligible for treatment with Doxycycline 100 mg twice daily for 3 weeks ; or
- pathology only (part B) for patients with other types of ocular lymphoma, inflammatory lesions or those ineligible/unwilling for treatment with doxycycline.
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
- •Age 18 years or over
- •Histologically confirmed marginal zone B-cell lymphoma of MALT-type
- •Lymphoma localised to the ocular adnexae (conjunctiva, lacrimal gland, orbit soft tissue, clinical stage IEA) following a CT scan of neck, thorax, abdomen and pelvis, bone marrow aspirate/trephine, full blood count and biochemical profile
- •No previous treatment, excepting RT for localised lymphoma of the contralateral eye
- •At least one measurable lesion
- •No systemic antibiotic therapy in the last three months
- •No other malignancy in the previous 5 years apart from appropriately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix
- •In women with reproductive potential a willingness to use contraception from entry into the study for a period of 3 months
- •Written informed consent
排除标准
- •Pregnant or lactating women
- •Known allergy to tetracycline
- •Patients unwilling to comply with the requirements of follow-up as defined by this protocol
- •Myasthenia gravis (tetracycline can exacerbate muscle weakness)
- •Systemic lupus erythematous (tetracycline can exacerbate the condition)
- •Patients with large or rapidly enlarging tumours requiring immediate radiotherapy
研究组 & 干预措施
doxycycline
Experimental
doxycycline 100 mg twice daily for 3 weeks
干预措施: doxycycline (tetracycline) (Drug)
结局指标
主要结局
response rates
时间窗: at 6 weeks, 12 weeks, 12 months and 24 months from start of doxycycline
次要结局
未报告次要终点
研究者
研究点 (6)
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