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

NCT ID: NCT01820910

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2026-06-30

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.

Conditions

Marginal Zone Lymphoma of Ocular Adnexal

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Doxycycline

Group Type: EXPERIMENTAL

Doxycycline

Intervention Type: DRUG

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.

Interventions

Doxycycline

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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

International Extranodal Lymphoma Study Group (IELSG)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrés Ferreri, MD

Role: STUDY_CHAIR

Ospedale San Raffaele, Milan, Italy

Locations

AO Ospedali Riuniti Papardo Piemonte

Messina, , Italy

Ospedale San Raffaele

Milan, , Italy

Ematologia

Parma, , Italy

Ospedale Civile

Piacenza, , Italy

Università La Sapienza

Rome, , Italy

Molinette 1

Torino, , Italy

Ospedale dell'Angelo

Venezia, , Italy

Countries

Italy

Other Identifiers

IELSG39

Identifier Type: -

Identifier Source: org_study_id