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Study on the Effectiveness of Doxycycline for Treating Newly Diagnosed Ocular Adnexal Marginal Zone Lymphoma Patients

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer called Ocular Adnexal Marginal Zone Lymphoma (OAMZL), which affects the tissues around the eyes. The study is investigating the effectiveness of a treatment using the antibiotic doxycycline. This treatment aims to eliminate a specific bacteria known as Chlamydophila psittaci, which may be linked to this type of lymphoma.

The purpose of the study is to determine how well this treatment works in patients who have been newly diagnosed with OAMZL. Participants will take doxycycline over an extended period, and their progress will be monitored to see if the bacteria is successfully eradicated. If the infection returns, the antibiotic treatment will be repeated. The study will observe how patients respond to this approach over time.

Throughout the study, researchers will also look at various factors, such as how well patients tolerate the treatment and how long they remain free of disease progression. The study will also explore genetic aspects of the lymphoma and any potential links to the bacterial infection. The goal is to gather comprehensive information that could improve understanding and treatment of OAMZL in the future.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    The treatment begins with the administration of doxycycline, an antibiotic taken orally. This medication is used to target and eradicate the Chlamydophila psittaci infection.

    The dosage and frequency of doxycycline will be determined by the medical team based on individual patient needs. The duration of this initial treatment phase is prolonged to ensure effective eradication of the infection.

  2. Step 2

    Eradication monitoring

    After the initial treatment phase, the patient's response to the therapy is monitored. This involves regular check-ups and tests to assess whether the Chlamydophila psittaci infection has been successfully eradicated.

    The monitoring phase is crucial to determine the effectiveness of the treatment and to identify any signs of infection re-occurrence.

  3. Step 3

    Antibiotic re-treatment

    If the infection re-occurs, a re-treatment with doxycycline is administered. This step ensures that any remaining infection is addressed promptly.

    The re-treatment phase follows the same administration guidelines as the initial treatment, with adjustments made as necessary based on the patient's condition and response.

  4. Step 4

    Follow-up and assessment

    Throughout the trial, regular follow-up appointments are scheduled to assess the patient's overall health and the progression of the Ocular Adnexal Marginal Zone Lymphoma (OAMZL).

    The primary goal is to achieve a 2-year progression-free survival, meaning the disease does not worsen during this period. Secondary assessments include evaluating the feasibility and tolerability of the treatment, as well as monitoring overall survival and infection eradication rates.

Who can join the trial?

14 criteria

  • Must have a confirmed diagnosis of Ocular Adnexal Marginal Zone Lymphoma (OAMZL).
  • No previous or current cancers, except for certain types that have been surgically cured or have shown no signs of disease for at least 5 years.
  • Must not have any family, social, or geographical issues that could prevent following the study and follow-up schedule.
  • If sexually active and able to have children, must use effective birth control during the study.
  • Must not be receiving any other experimental drugs at the same time.
  • Must have signed a consent form agreeing to participate in the study.
  • Must have a single or double lesion (stage IE) located in the eye area, such as the conjunctiva, lachrymal gland or sac, or the soft tissue around the eye.
  • Must not have B symptoms, which are specific symptoms like fever, night sweats, and weight loss.
  • Must not have received any treatment for the condition before.
  • Must not have taken any systemic antibiotics in the last 3 months.
  • Must be older than 18 years.
  • Must have an ECOG PS (Eastern Cooperative Oncology Group Performance Status) score of 0-2, which indicates the level of daily functioning.
  • Must test negative for HIV, HBV (Hepatitis B Virus), and HCV (Hepatitis C Virus).
  • Must have adequate functioning of the bone marrow, kidneys, and liver.

Who cannot join the trial?

7 criteria

  • Patients who do not have a newly diagnosed condition called **Ocular Adnexal Marginal Zone Lymphoma (OAMZL)** cannot participate. This is a specific type of cancer that affects the tissues around the eyes.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are not able to follow the study procedures or take the required medications as directed cannot participate.
  • Patients who have other medical conditions that might interfere with the study or its results cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate, as the study may involve medications that could affect the baby.
  • Patients who are participating in another clinical trial at the same time cannot participate, to ensure the study results are not affected by other treatments.
  • Patients who have allergies or reactions to the study medications cannot participate, to avoid any harmful effects.
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Investigated drugs

Doxycycline is an antibiotic used in this trial to treat patients with newly diagnosed Ocular Adnexal Marginal Zone Lymphoma (OAMZL). The goal is to eradicate the Chlamydophila psittaci infection, which is believed to be associated with this type of lymphoma. The treatment involves a prolonged administration of doxycycline, and patients are monitored for the infection. If the infection reoccurs, the antibiotic treatment is repeated.

What is already known about the treatment

Doxycycline – Doxycycline is an antibiotic administered orally, typically in the form of tablets or capsules. It is currently being studied in a Phase 2 clinical trial for its effectiveness in treating patients with newly diagnosed Ocular Adnexal Marginal Zone Lymphoma (OAMZL) by eradicating the Chlamydophila psittaci infection. The main therapeutic indication is to target and eliminate this bacterial infection, which is believed to be associated with the lymphoma. At the molecular level, doxycycline works by inhibiting protein synthesis in bacteria, thereby stopping their growth and reproduction. It is classified as a tetracycline antibiotic, known for its broad-spectrum antibacterial activity.

Investigated diseases

Ocular Adnexal Marginal Zone Lymphoma – This is a type of cancer that affects the tissues surrounding the eye, known as the ocular adnexa. It is a subtype of non-Hodgkin lymphoma, specifically a marginal zone lymphoma, which typically involves slow-growing tumors. The disease often presents with symptoms such as swelling or a mass around the eye, which may lead to discomfort or vision changes. As it progresses, the lymphoma can spread to nearby tissues or other parts of the body. The condition is considered rare and may be associated with certain infections, such as Chlamydophila psittaci. Monitoring and management of the disease focus on controlling its progression and addressing any associated infections.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-513426-29-00Protocol codeIELSG39Estimated enrolment44 patientsSponsorAssociation International Extranodal Lymphoma Study Group (IELSG)

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).