Status:
ACTIVE_NOT_RECRUITING
Phase II Trial of First-line Doxycycline for Ocular Adnexal Marginal Zone Lymphoma Treatment
Lead Sponsor:
International Extranodal Lymphoma Study Group (IELSG)
Conditions:
Marginal Zone Lymphoma of Ocular Adnexal
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT01820910
Start Date
March 1 2013
End Date
December 1 2025
Last Update
May 4 2025
Active Locations (7)
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1
AO Ospedali Riuniti Papardo Piemonte
Messina, Italy
2
Ospedale San Raffaele
Milan, Italy
3
Ematologia
Parma, Italy
4
Ospedale Civile
Piacenza, Italy