International prospective Phase 2 trial addressing the efficacy of first-lineChlamydophila psittaci-eradicating therapy with protracted administration ofdoxycycline followed by eradication monitoring and antibiotic re-treatment atinfection re-occurrence in patients with newly diagnosed Ocular Adnexal Margina Zone Lymphoma (OAMZL).
- Conditions
- Patients with newly diagnosed Ocular Adnexal Marginal Zone Lymphoma (OAMZL)Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2012-005702-22-IT
- Lead Sponsor
- INTERNATIONAL EXTRANODAL LYMPHOMA STUDY GROUP
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 34
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Secondary end point(s): The secondary endpoints are:<br>1. Feasibility<br>2. Tolerability of prolonged administration of doxycycline<br>3. Activity (overall response rate)<br>4. Overall survival<br>5. Cp eradication rate<br>6. Infection re-occurrence rate<br>7. Assessment of prevalence of IRTA1 marker in OAMZL<br>8. Assessment of genetic lesions and gene expression changes in OAMZL and their possible relationship with Cp infection and response to treatment<br>9. Identification of possible SNPs associated with Cp infection in OAMZL patients<br>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.<br>Overall Survival at 5 years.