This trial is active, not recruiting.

Condition marginal zone lymphoma of ocular adnexal
Treatment doxycycline
Phase phase 2
Sponsor International Extranodal Lymphoma Study Group (IELSG)
Start date March 2013
End date May 2016
Trial size 34 participants
Trial identifier NCT01820910, IELSG39


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
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

progression-free survival (PFS)
time frame: 2-year from start of treatment

Eligibility Criteria

Male or female participants at least 18 years old.

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 11. Absence of any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule 12. Sexually active patients of childbearing potential must implement adequate contraceptive measures during study participation 13. No concurrent treatment with other experimental drugs 14. Patient-signed informed consent obtained before registration 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

Additional Information

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)
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by International Extranodal Lymphoma Study Group (IELSG).