A Clinico-Pathological Study to Investigate the Possible Infective Causes of Non-Hodgkin Lymphoma of the Ocular Adnexae

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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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

Conditions
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Non-Hodgkin Lymphoma

Intervention / Treatment
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* Drug: doxycycline (tetracycline)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: doxycycline<br>doxycycline 100 mg twice daily for 3 weeks | Drug: doxycycline (tetracycline)<br>* doxycycline 100 mg twice daily for 3 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rates |  | at 6 weeks, 12 weeks, 12 months and 24 months from start of doxycycline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NHL of the ocular adnexae