Phase II Trial of First-line Doxycycline for Ocular Adnexal Marginal Zone Lymphoma Treatment
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Doxycycline
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Drug: Doxycycline
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.
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Outcome Measures
Primary Outcome Measures
- progression-free survival (PFS) [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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Histological diagnosis of marginal zone lymphoma of the ocular adnexae (OAMZL)
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Single or bilateral lesion (stage IE) localised to the ocular adnexae (conjunctiva, lachrymal gland or sac, orbit soft tissue, eyelid)
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Absence of B symptoms
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Previously untreated patients
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No systemic antibiotic therapy in the last three months before enrolment
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Age >18 years
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ECOG PS 0-2
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Negative HIV, HBV and HCV serology
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Adequate bone marrow, renal, and hepatic function
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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
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Absence of any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
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Sexually active patients of childbearing potential must implement adequate contraceptive measures during study participation
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No concurrent treatment with other experimental drugs
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Patient-signed informed consent obtained before registration
Exclusion Criteria:
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Pregnant or lactating women
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Known allergy to tetracycline
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Patients unwilling to comply with the requirements of follow-up
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Myasthenia gravis (tetracycline can exacerbate muscle weakness)
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Systemic lupus erythematous (tetracycline can exacerbate this condition)
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Patients with large or rapidly enlarging tumors requiring immediate radiotherapy
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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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 | ||
5 | Università La Sapienza | Rome | Italy | ||
6 | Molinette 1 | Torino | Italy | ||
7 | Ospedale dell'Angelo | Venezia | Italy |
Sponsors and Collaborators
- International Extranodal Lymphoma Study Group (IELSG)
Investigators
- Study Chair: Andrés Ferreri, MD, Ospedale San Raffaele, Milan, Italy
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IELSG39