Clinical trial NCT01820910: Phase II Trial of First-line Doxycycline for Ocular Adnexal Marginal Zone Lymphoma Treatment
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Marginal Zone Lymphoma of Ocular Adnexal
Lead sponsor: International Extranodal Lymphoma Study Group (IELSG)
Sponsor class: OTHER
First posted: 2013-03-29
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: progression-free survival (PFS)
timeFrame: 2-year from start of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Messina
country: Italy
facility: AO Ospedali Riuniti Papardo Piemonte
city: Milan
country: Italy
facility: Ospedale San Raffaele
city: Parma
country: Italy
facility: Ematologia
city: Piacenza
country: Italy
facility: Ospedale Civile
city: Rome
country: Italy
facility: Università La Sapienza
city: Torino
country: Italy
facility: Molinette 1
city: Venezia
country: Italy
facility: Ospedale dell'Angelo
Study officials:
affiliation: Ospedale San Raffaele, Milan, Italy
name: Andrés Ferreri, MD
role: STUDY_CHAIR
References: