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

NCT01820910 | Completed Phase 2

• 1 other identifier: IELSG39
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 8

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

Outcome Measures

Primary Outcomes (1)

• progression-free survival (PFS)

  from the date of the start of treatment to relapse, progression or death, or to the last date of follow-up

  2-year from start of treatment

Study Arms (1)

Doxycycline

EXPERIMENTAL

Drug: Doxycycline

Interventions

Doxycycline 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.

Doxycycline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological diagnosis of marginal zone lymphoma of the ocular adnexae (OAMZL)
• Single or bilateral lesion (stage IE) localised to the ocular adnexae (conjunctiva, lachrymal gland or sac, orbit soft tissue, eyelid)
• Absence of B symptoms
• Previously untreated patients
• No systemic antibiotic therapy in the last three months before enrolment
• Age \>18 years
• ECOG PS 0-2
• Negative HIV, HBV and HCV serology
• Adequate bone marrow, renal, and hepatic function
• 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
• Absence of any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
• Sexually active patients of childbearing potential must implement adequate contraceptive measures during study participation
• No concurrent treatment with other experimental drugs
• Patient-signed informed consent obtained before registration

You may not qualify if:

• Pregnant or lactating women
• Known allergy to tetracycline
• Patients unwilling to comply with the requirements of follow-up
• Myasthenia gravis (tetracycline can exacerbate muscle weakness)
• Systemic lupus erythematous (tetracycline can exacerbate this condition)
• Patients with large or rapidly enlarging tumors requiring immediate radiotherapy

Sponsors & Collaborators

• International Extranodal Lymphoma Study Group (IELSG): lead

Study Sites (8)

Spedali Civili Di Brescia

Brescia, Italy

Location

AO Ospedali Riuniti Papardo Piemonte

Messina, Italy

Location

Ospedale San Raffaele

Milan, Italy

Location

Ematologia

Parma, Italy

Location

Ospedale Civile

Piacenza, Italy

Location

Università La Sapienza

Rome, Italy

Location

Molinette 1

Torino, Italy

Location

Ospedale dell'Angelo

Venezia, Italy

Location

MeSH Terms

Interventions

Doxycycline

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Andrés Ferreri, MD

  Ospedale San Raffaele, Milan, Italy

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2013
• First Posted: March 29, 2013
• Study Start: March 19, 2013
• Primary Completion: May 1, 2016
• Study Completion: April 1, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

IT (8)