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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01010295

Acronym

IELSG27

Enrollment

Registered

2009-11-10

Start date

2006-09-30

Completion date

2012-05-31

Last updated

2013-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Hodgkin Lymphoma

Keywords

NHL of the ocular adnexae

Brief summary

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

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.

Interventions

DRUGdoxycycline (tetracycline)

doxycycline 100 mg twice daily for 3 weeks

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Age 18 years or over 2. Histologically confirmed marginal zone B-cell lymphoma of MALT-type 3. 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 4. No previous treatment, excepting RT for localised lymphoma of the contralateral eye 5. At least one measurable lesion 6. No systemic antibiotic therapy in the last three months 7. 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 8. In women with reproductive potential a willingness to use contraception from entry into the study for a period of 3 months 9. Written informed consent

Exclusion criteria

1. Pregnant or lactating women 2. Known allergy to tetracycline 3. Patients unwilling to comply with the requirements of follow-up as defined by this protocol 4. Myasthenia gravis (tetracycline can exacerbate muscle weakness) 5. Systemic lupus erythematous (tetracycline can exacerbate the condition) 6. Patients with large or rapidly enlarging tumours requiring immediate radiotherapy

Design outcomes

Primary

Measure	Time frame
response rates	at 6 weeks, 12 weeks, 12 months and 24 months from start of doxycycline

Countries

Chile, Italy, Spain, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026