MALT lymphoma of the ocular adnexae MedDRA version: 6.1 Level: PT Classification code 10061850
Conditions
Interventions
Trade Name: DOXICICLINA CLORIDR 8CPS 100MG
Product Name: DOXICICLINA
Pharmaceutical Form: Modified-release capsule, soft
INN or Proposed INN: Doxycycline
Concentration unit: mg milligram(s)
Concentra
Sponsors
INTERNATIONAL EXTRANODAL LYMPHOMA STUDY GROUP (IELSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 16 years or over 2. Histologically confirmed marginal zone B-cell lymphoma of MALT-type 3. Lymphoma localised to the ocular adnexae (conjunctiva, lacrymal gland, orbit soft tissue, clinical stage IEA) 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 Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 |
|---|---|
| Main Objective: 1. To explore the role of antibiotic therapy in the treatment of MLOA and correlate the treatment response to molecular genetic findings. 2. To comprehensively screen infectious agents associated with chronic eye infection including Chlamydia, herpes simplex virus and adenovirus in MLOA and various controls (other types of ocular adnexal lymphomas, inflammatory conditions) using molecular, immunohistological and serological tests with a view to identifying the agents associated with these lymphomas.;Secondary Objective: 1. Identification of the infectious agents associated with MLOA 2. Geographical variation in distribution of potential infective agents associated with MLOA in particular Chlamydia species 3. Molecular factors associated with response/non-response to tetracycline in MLOA;Primary end point(s): Response rates and duration of response to tetracycline in patients with MALT lymphoma of the ocular adnexae (MLOA) | — |
Countries
Italy
Outcome results
None listed