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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01820910

Enrollment

Registered

2013-03-29

Start date

2013-03-19

Completion date

2026-04-01

Last updated

2026-04-24

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

Conditions

Marginal Zone Lymphoma of Ocular Adnexal

Brief 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.

Interventions

DRUGDoxycycline

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.

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. 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

Design outcomes

Primary

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

Countries

Italy

Contacts

STUDY_CHAIRAndrés Ferreri, MD

Ospedale San Raffaele, Milan, Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 25, 2026