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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)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Marginal Zone Lymphoma of Ocular Adnexal

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Trial Information

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)


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

progression-free survival (PFS)

Outcome Description:

from the date of the start of treatment to relapse, progression or death, or to the last date of follow-up

Outcome Time Frame:

2-year from start of treatment

Safety Issue:

No

Principal Investigator

Andrés Ferreri, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Ospedale San Raffaele, Milan, Italy

Authority:

Italy: The Italian Medicines Agency

Study ID:

IELSG39

NCT ID:

NCT01820910

Start Date:

March 2013

Completion Date:

September 2023

Related Keywords:

  • Marginal Zone Lymphoma of Ocular Adnexal
  • Lymphoma
  • Lymphoma, B-Cell, Marginal Zone

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