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Phase II Trial of First-line Doxycycline for Ocular Adnexal Marginal Zone Lymphoma Treatment | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

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

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)

NCT01820910•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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+4 more criteria

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

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

Key Dates

Start Date

March 1, 2013

Primary Completion Date

May 1, 2016

Completion Date

June 1, 2026

Last Updated

January 15, 2026

Enrollment

ACTUAL participants

Conditions

Marginal Zone Lymphoma of Ocular Adnexal

Interventions

Doxycycline

DRUG