CompletedPhase 2

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

Italy44 participantsStarted 2013-03-19

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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

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

What they're measuring

progression-free survival (PFS)

Timeframe: 2-year from start of treatment

Trial details

NCT IDNCT01820910

SponsorInternational Extranodal Lymphoma Study Group (IELSG)

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-05

View on ClinicalTrials.gov More Marginal Zone Lymphoma of Ocular Adnexal trials