NCT01820910
Completed
Phase 2
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)
International Extranodal Lymphoma Study Group (IELSG)8 sites in 1 country44 target enrollmentMarch 19, 2013
ConditionsMarginal Zone Lymphoma of Ocular Adnexal
InterventionsDoxycycline
Overview
- Phase
- Phase 2
- Intervention
- Doxycycline
- Conditions
- Marginal Zone Lymphoma of Ocular Adnexal
- Sponsor
- International Extranodal Lymphoma Study Group (IELSG)
- Enrollment
- 44
- Locations
- 8
- Primary Endpoint
- progression-free survival (PFS)
- Status
- Completed
- Last Updated
- 8 days ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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
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
Arms & Interventions
Doxycycline
Intervention: Doxycycline
Outcomes
Primary Outcomes
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
Study Sites (8)
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