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

Phase 2

Active, not recruiting

• Conditions: Marginal Zone Lymphoma of Ocular Adnexal
• Interventions: Drug: Doxycycline

• Registration Number: NCT01820910
• Lead Sponsor: International Extranodal Lymphoma Study Group (IELSG)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-26
• Study First Submitted QC: 2013-03-26
• Study First Posted: 2013-03-29
• Primary Completion: 2016-05
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-02
• Last Update Posted: 2025-05-04
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Doxycycline	Doxycycline	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (7)

Ospedale San Raffaele; 🇮🇹 Milan, Italy

AO Ospedali Riuniti Papardo Piemonte; 🇮🇹 Messina, Italy

Ematologia; 🇮🇹 Parma, Italy

Ospedale Civile; 🇮🇹 Piacenza, Italy

Università La Sapienza; 🇮🇹 Rome, Italy

Molinette 1; 🇮🇹 Torino, Italy

Ospedale dell'Angelo; 🇮🇹 Venezia, Italy