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

NCT01820910 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2026-04-24

No results posted yet for this study

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

Interventions

DRUG

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.

Sponsors & Collaborators

  • International Extranodal Lymphoma Study Group (IELSG)

    lead OTHER

Principal Investigators

  • Andrés Ferreri, MD · Ospedale San Raffaele, Milan, Italy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-19
Primary Completion
2016-05-31
Completion
2026-04-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01820910 on ClinicalTrials.gov