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Completed

NCT Number: NCT01820910

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

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.

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Key information

Conditions

Marginal Zone Lymphoma of Ocular Adnexal

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Spedali Civili Di Brescia, Brescia, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. progression-free survival (PFS)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

International Extranodal Lymphoma Study Group (IELSG)

Other

Registry information

Official study 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)

Important dates

Study start
2013
Primary completion
2016
Study completion
2026
First posted
Mar 29, 2013
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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