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

• Status: Active, not recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: International Extranodal Lymphoma Study Group (IELSG)
• Treatments: Doxycycline

Criteria

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