Marginal Zone Lymphoma of Ocular AdnexalPhase 2NCT01820910
Phase II Trial of First-line Doxycycline for Ocular Adnexal Marginal Zone Lymphoma Treatment
A Phase 2 study testing Doxycycline in people with Marginal Zone Lymphoma of Ocular Adnexal, run by International Extranodal Lymphoma Study Group (IELSG) at 8 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Marginal Zone Lymphoma of Ocular Adnexal
- What is being tested?
- Doxycycline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 8 sitesItaly
- Study dates
- 19 Mar 2013to 1 Apr 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological diagnosis of marginal zone lymphoma of the ocular adnexae (OAMZL)
- Single or bilateral lesion (stage IE) localised to the ocular adnexae (conjunctiva, lachrymal gland or sac, orbit soft tissue, eyelid)
- Absence of B symptoms
- Previously untreated patients
- No systemic antibiotic therapy in the last three months before enrolment
- Age >18 years
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- ECOG PS 0-2
- Negative HIV, HBV and HCV serology
- Adequate bone marrow, renal, and hepatic function
- 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
- Absence of any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- Sexually active patients of childbearing potential must implement adequate contraceptive measures during study participation
- No concurrent treatment with other experimental drugs
- Patient-signed informed consent obtained before registration
Who cannot join
- Pregnant or lactating women
- Known allergy to tetracycline
- Patients unwilling to comply with the requirements of follow-up
- Myasthenia gravis (tetracycline can exacerbate muscle weakness)
- Systemic lupus erythematous (tetracycline can exacerbate this condition)
- Patients with large or rapidly enlarging tumors requiring immediate radiotherapy
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Italy8 sites
Spedali Civili Di Brescia
Brescia
AO Ospedali Riuniti Papardo Piemonte
Messina
Ospedale San Raffaele
Milan
Ematologia
Parma
Ospedale Civile
Piacenza
Università La Sapienza
Rome
Molinette 1
Torino
Ospedale dell'Angelo
Venezia
About this study
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)
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.
- Conditions
- Marginal Zone Lymphoma of Ocular Adnexal
- Being tested
- Doxycycline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxycyclineDrug
All enrolled patients will be treated with doxycycline 100 mg bid daily, orally, for four weeks followed by four weeks rest, repeated for three cycles. Response will be assessed by MRI (magnetic resonance imaging) and ophthalmologic examination at the end of the planned treatment. Patients who will achieve complete response, partial response or have a stable disease at 3 months from upfront doxycycline will be monitored for infection re-occurrence and assessed for response with MRI and ophthalmologist evaluation every six months for the first five years.
| Study group | Role | What they receive |
|---|---|---|
| Doxycycline | Experimental | Not described Receives: Drug: Doxycycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival (PFS)
from the date of the start of treatment to relapse, progression or death, or to the last date of follow-up
Measured: 2-year from start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2013 (estimated)
- Study start19 Mar 2013
- Primary completionMay 2016
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Marginal Zone Lymphoma of Ocular AdnexalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Extranodal Lymphoma Study Group (IELSG)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrés Ferreri, MD, Study chair, Ospedale San Raffaele, Milan, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01820910
- Sponsor's protocol ID
- IELSG39
- Status last verified
- Apr 2026
- First submitted
- 26 Mar 2013
- Last updated
- 24 Apr 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01820910
- Acronym / sponsor ID
- IELSG39
- Conditions
- Marginal Zone Lymphoma of Ocular Adnexal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- International Extranodal Lymphoma Study Group (IELSG)University, hospital or other
- Study start
- 19 Mar 2013
- Primary completion
- May 2016 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 29 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Doxycycline | Experimental | Drug: Doxycycline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histological diagnosis of marginal zone lymphoma of the ocular adnexae (OAMZL)
- Single or bilateral lesion (stage IE) localised to the ocular adnexae (conjunctiva, lachrymal gland or sac, orbit soft tissue, eyelid)
- Absence of B symptoms
- Previously untreated patients
- No systemic antibiotic therapy in the last three months before enrolment
Key exclusion criteria (6 listed)
- Pregnant or lactating women
- Known allergy to tetracycline
- Patients unwilling to comply with the requirements of follow-up
- Myasthenia gravis (tetracycline can exacerbate muscle weakness)
- Systemic lupus erythematous (tetracycline can exacerbate this condition)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DoxycyclineAll enrolled patients will be treated with doxycycline 100 mg bid daily, orally, for four weeks followed by four weeks rest, repeated for three cycles. Response will be assessed by MRI (magnetic resonance imaging) and ophthalmologic examination at the end of the planned treatment. Patients who will achieve complete response, partial response or have a stable disease at 3 months from upfront doxycycline will be monitored for infection re-occurrence and assessed for response with MRI and ophthalmologist evaluation every six months for the first five years. | Drug | Doxycycline |
Primary outcome
progression-free survival (PFS)
Time frame: 2-year from start of treatment
from the date of the start of treatment to relapse, progression or death, or to the last date of follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrés Ferreri, MD study chair
Ospedale San Raffaele, Milan, Italy
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Doxycycline in people with Marginal Zone Lymphoma of Ocular Adnexal, run by International Extranodal Lymphoma Study Group (IELSG) at 8 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (PFS) (time frame: 2-year from start of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.