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ACTIVE NOT RECRUITING
NCT01820910
PHASE2

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

Sponsor: International Extranodal Lymphoma Study Group (IELSG)

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

34

Start Date

2013-03

Completion Date

2026-06

Last Updated

2026-01-15

Healthy Volunteers

No

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.

Locations (7)

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