Clinical trial · Interventional
Phase II Trial of First-line Doxycycline for Ocular Adnexal Marginal Zone Lymphoma Treatment
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Marginal Zone Lymphoma of Ocular Adnexal | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Doxycycline | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Doxycycline
- interventionNames
- Drug: Doxycycline
Primary outcomes (1)
- measure
- progression-free survival (PFS)
- timeFrame
- 2-year from start of treatment
- description
- from the date of the start of treatment to relapse, progression or death, or to the last date of follow-up
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histological diagnosis of marginal zone lymphoma of the ocular adnexae (OAMZL) 2. Single or bilateral lesion (stage IE) localised to the ocular adnexae (conjunctiva, lachrymal gland or sac, orbit soft tissue, eyelid) 3. Absence of B symptoms 4. Previously untreated patients 5. No systemic antibiotic therapy in the last three months before enrolment 6. Age \>18 years 7. ECOG PS 0-2 8. Negative HIV, HBV and HCV serology 9. Adequate bone marrow, renal, and hepatic function 10. 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 11. Absence of any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule 12. Sexually active patients of childbearing potential must implement adequate contraceptive measures during study participation 13. No concurrent treatment with other experimental drugs 14. Patient-signed informed consent obtained before registration Exclusion Criteria: 1. Pregnant or lactating women 2. Known allergy to tetracycline 3. Patients unwilling to comply with the requirements of follow-up 4. Myasthenia gravis (tetracycline can exacerbate muscle weakness) 5. Systemic lupus erythematous (tetracycline can exacerbate this condition) 6. Patients with large or rapidly enlarging tumors requiring immediate radiotherapy
References
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