Marginal Zone Lymphoma of Ocular Adnexal Clinical Trial
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)
| Verified date | April 2024 |
| Source | International Extranodal Lymphoma Study Group (IELSG) |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 34 |
| Est. completion date | September 2025 |
| Est. primary completion date | May 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Italy | AO Ospedali Riuniti Papardo Piemonte | Messina | |
| Italy | Ospedale San Raffaele | Milan | |
| Italy | Ematologia | Parma | |
| Italy | Ospedale Civile | Piacenza | |
| Italy | Università La Sapienza | Rome | |
| Italy | Molinette 1 | Torino | |
| Italy | Ospedale dell'Angelo | Venezia |
| Lead Sponsor | Collaborator |
|---|---|
| International Extranodal Lymphoma Study Group (IELSG) |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | progression-free survival (PFS) | from the date of the start of treatment to relapse, progression or death, or to the last date of follow-up | 2-year from start of treatment |