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 Margina Zone Lymphoma (OAMZL).

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 Margina Zone Lymphoma (OAMZL). - IELSG39

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-005702-22-IT

Enrollment

Registered

2013-02-06

Start date

2013-03-17

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with newly diagnosed Ocular Adnexal Marginal Zone Lymphoma (OAMZL)

Interventions

Trade Name: BASSADO (DOXYCYCLINE) Product Name: DOXYCYCLINE Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histological diagnosis of OAMZL 2. Single or bilateral lesion (stage IE) localized to the ocular adnexae (conjunctiva, lachrymal gland or sac, orbit soft tissue) 3. Absence of B symptoms 4. Previously untreated patients 5. No systemic antibiotic therapy in the last 3 months 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, prostatic cancer, 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 study & 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 14

Exclusion criteria

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 tumours requiring immediate radiotherapy

Design outcomes

Primary

Measure	Time frame
Main Objective: To establish in a prospective, multicentre phase 2 trial, 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 OAMZL.;Secondary Objective: Not applicable.;Primary end point(s): The primary endpoint is the 2-year progression-free survival (PFS) of patients with newly diagnosed stage-IE OAMZL treated with the experimental strategy.;Timepoint(s) of evaluation of this end point: 2 years	—

Measure

Time frame

Main Objective: To establish in a prospective, multicentre phase 2 trial, 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 OAMZL.;Secondary Objective: Not applicable.;Primary end point(s): The primary endpoint is the 2-year progression-free survival (PFS) of patients with newly diagnosed stage-IE OAMZL treated with the experimental strategy.;Timepoint(s) of evaluation of this end point: 2 years

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Secondary

Measure	Time frame
Secondary end point(s): The secondary endpoints are: 1. Feasibility 2. Tolerability of prolonged administration of doxycycline 3. Activity (overall response rate) 4. Overall survival 5. Cp eradication rate 6. Infection re-occurrence rate 7. Assessment of prevalence of IRTA1 marker in OAMZL 8. Assessment of genetic lesions and gene expression changes in OAMZL and their possible relationship with Cp infection and response to treatment 9. Identification of possible SNPs associated with Cp infection in OAMZL patients 10. Identification of possible bacterial polymorphisms responsible for antibiotic resistance, infection recurrence or persistence.;Timepoint(s) of evaluation of this end point: Infection re-occurrence rate at 3 years. Overall Survival at 5 years.	—

Measure

Time frame

Secondary end point(s): The secondary endpoints are: 1. Feasibility 2. Tolerability of prolonged administration of doxycycline 3. Activity (overall response rate) 4. Overall survival 5. Cp eradication rate 6. Infection re-occurrence rate 7. Assessment of prevalence of IRTA1 marker in OAMZL 8. Assessment of genetic lesions and gene expression changes in OAMZL and their possible relationship with Cp infection and response to treatment 9. Identification of possible SNPs associated with Cp infection in OAMZL patients 10. Identification of possible bacterial polymorphisms responsible for antibiotic resistance, infection recurrence or persistence.;Timepoint(s) of evaluation of this end point: Infection re-occurrence rate at 3 years. Overall Survival at 5 years.

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Countries

Italy, Switzerland

Contacts

Public ContactFIL SECRETARY

FONDAZIONE ITALIANA LINFOMI ONLUS

segreteria@filinf.it00390131206132

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026