Clinical 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).

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Association International Extranodal Lymphoma Study Group (IELSG)

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Hemic and Lymphatic Diseases [C15]

Trial duration

19 Mar 2013 → 1 Apr 2026

Decision date (initial)

2025-01-13

Transition trial

Yes

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

External identifiers

EU CT number

2024-513426-29-00

EudraCT number

2012-005702-22

ClinicalTrials.gov

NCT01820910

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy

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 objectives 1

1. Not applicable

Conditions and MedDRA coding

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

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 14

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

Exclusion criteria 7

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
7. Obstructive disorders of the esophagus, such as stenosis or achalasia

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint is the 2-year progression-free survival (PFS) of patients with newly diagnosed stage-IE OAMZL treated with the experimental strategy

Secondary endpoints 10

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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Association International Extranodal Lymphoma Study Group (IELSG)

Sponsor organisation

Association International Extranodal Lymphoma Study Group (IELSG)

Address

Via Vincenzo Vela 6

City

Bellinzona

Postcode

6500

Country

Switzerland

Scientific contact point

Organisation

Association International Extranodal Lymphoma Study Group (IELSG)

Contact name

IELSG Operations Office

Public contact point

Organisation

Association International Extranodal Lymphoma Study Group (IELSG)

Contact name

IELSG Operations Office

Locations

1 EU/EEA country · 8 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications