Phase II Trial of First-line Doxycycline for Ocular Adnexal Marginal Zone Lymphoma Treatment

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Marginal Zone Lymphoma of Ocular Adnexal

Intervention / Treatment
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* Drug: Doxycycline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

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> | Drug: Doxycycline<br>* All enrolled patients will be treated with doxycycline 100 mg bid daily, orally, for four weeks followed by four weeks rest, repeated for three cycles. Response will be assessed by MRI (magnetic resonance imaging) and ophthalmologic examination at the end of the planned treatment. Patients who will achieve complete response, partial response or have a stable disease at 3 months from upfront doxycycline will be monitored for infection re-occurrence and assessed for response with MRI and ophthalmologist evaluation every six months for the first five years.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival (PFS) | from the date of the start of treatment to relapse, progression or death, or to the last date of follow-up | 2-year from start of treatment |