Phase 3 Lymphoma Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have a confirmed diagnosis of marginal zone lymphoma (MZL) — a type of slow-growing blood cancer — in one of several forms: extranodal (affecting tissues outside lymph nodes), nodal (affecting lymph nodes), splenic (affecting the spleen), or widely spread (disseminated). The diagnosis must be confirmed by biopsy or by specific laboratory blood tests reviewed by a central panel.
• People who have already received between one and three prior treatments for their lymphoma, and whose previous treatment included at least one course of a drug that targets a protein called CD20 (such as rituximab), with or without chemotherapy or certain targeted medicines.
• People aged 18 or older at the time of signing the consent form.
• People who are well enough to follow the study schedule and required hospital visits, as assessed by the treating doctor.
• People whose general health and physical functioning score (a standard medical scale called ECOG) is rated 0, 1, or 2 — meaning they are able to carry out basic daily activities, even if they have some symptoms.
• People whose lymphoma is causing symptoms that require treatment with medicines given throughout the body (systemic treatment).
• People whose lymphoma cannot be treated with a local approach such as radiotherapy or surgery.
• People whose lymphoma can be measured on a scan — specifically, a lymph node or tumour mass measuring at least 15 mm in its longest dimension, or at least 10 mm in its shorter dimension; or a spleen measuring more than 130 mm vertically.
• People with blood counts that meet minimum levels at the screening stage (unless low counts are directly caused by the lymphoma affecting the bone marrow, the spleen, or an immune reaction — confirm specific thresholds with the trial site).
• People with liver function test results within acceptable ranges, unless any abnormality is directly due to the lymphoma (confirm specific thresholds with the trial site).
• People with kidneys working at 40 mL/min or above, as measured by a standard test.
• People whose hepatitis B test results meet specific requirements — including being negative for active hepatitis B virus, confirmed by a PCR blood test if needed (confirm details with the trial site).
• Women who could become pregnant must have a negative pregnancy test within 7 days before starting treatment, and must agree to use highly effective contraception and avoid breastfeeding during the study and for a specified period after treatment ends (the required period varies depending on which study drugs are used — confirm with the trial site).
• Men with a partner who could become pregnant must agree to use contraception and avoid donating sperm during treatment and for a specified period after treatment ends (the required period varies depending on which study drugs are used — confirm with the trial site).
• People covered by the French social security system (this trial is based in France).
• People who understand and speak an official language of the country where the trial is taking place.
• People with normal or near-normal heart pumping function, confirmed by an echocardiogram or a specific heart scan (MUGA).

Who may not be able to join:

• People whose MZL has transformed into a fast-growing (high-grade) lymphoma.
• People who have previously been treated with mosunetuzumab or similar medicines that target both CD20 and CD3 at the same time.
• People who have previously had an allogeneic stem cell transplant (a transplant using donor stem cells).
• People who have received radiotherapy within 2 weeks before the first study treatment.
• People who have had an autologous stem cell transplant (using their own stem cells) within 100 days before the first study treatment.
• People who have received a monoclonal antibody treatment within 4 weeks before the first study treatment.
• People who have been on long-term immune-suppressing medicines (such as certain chemotherapy agents, methotrexate, or anti-inflammatory biologics) — with some exceptions for inhaled or topical steroids, or short-term low-dose steroids for symptom control (confirm with trial site).
• People who have received any other experimental anti-cancer treatment within 4 weeks before starting the study.
• People who are pregnant, breastfeeding, or planning to become pregnant during the study or within a specified time after treatment ends.
• People who have received a live vaccine within 4 weeks before starting treatment, or who are expected to need one during the study or within 6 months after finishing treatment (with possible exceptions for pandemic situations such as COVID-19).
• People with active lymphoma in the brain or fluid around the brain, or a history of this.
• People who have had a severe allergic reaction (grade 3 or 4) to antibody-based therapies in the past.
• People with a known allergy to any of the study drugs or their ingredients, including mannitol.
• People who cannot safely receive blood clot prevention medicines.
• People with a history of another cancer, unless it was successfully treated at least 2 years ago with no signs of return, or was a limited skin cancer, cervical cancer in situ, or early-stage prostate cancer treated adequately — and only if they have fully recovered from any side effects of that prior treatment.
• People with a serious active infection requiring hospital treatment or IV antibiotics within the 4 weeks before joining, or a known ongoing infection.
• People with significant heart disease, recent heart attack (within 6 months), unstable heart rhythm, or unstable chest pain.
• People with significant lung disease.
• People with significant liver disease, including cirrhosis or active hepatitis.
• People with certain brain or nervous system conditions (such as recent stroke or epilepsy with recent seizures) — some exceptions may apply depending on the specific history (confirm with trial site).
• People with a history of a rare and serious brain condition called progressive multifocal leukoencephalopathy (PML).
• People who test positive for HIV.
• People with active hepatitis C virus infection (a negative PCR test result is required even if the hepatitis C antibody test is positive).
• People with a known or suspected history of a rare immune condition called hemophagocytic lymphohistiocytosis (HLH).
• People with a known or suspected active Epstein-Barr virus (EBV) infection within the 4 weeks before joining.
• People who have previously had a severe skin reaction (grade 3 or higher rash or blistering) from a type of drug called immunomodulatory agents.
• People with a history of lung inflammation caused by drugs, autoimmune conditions, or scar tissue in the lungs (interstitial lung disease).
• People with an active autoimmune disease that currently requires treatment — some exceptions may apply (such as stable thyroid conditions, controlled Type 1 diabetes, or certain blood-related immune conditions — confirm with trial site).
• People with a history of certain autoimmune conditions — some exceptions may apply for well-controlled or historical cases after review by the medical team (confirm with trial site).
• People who have had major surgery with a bleeding risk within 4 weeks before starting treatment.
• People who have had a solid organ transplant (such as a kidney or liver transplant).
• People who, in the treating doctor's judgement, have a serious medical condition that would make participation unsafe.
• People who are detained by a legal or administrative decision, hospitalised without their consent, or under legal guardianship.
• People who are unable to give informed consent due to a serious medical, cognitive, or psychiatric condition.
• People whose lymphoma shows signs of having transformed into a more aggressive type at the time of enrolment, based on scan findings or other clinical signs (confirm with trial site if there is any uncertainty).
• People with uncontrolled fluid build-up around the lungs or other body cavities requiring urgent treatment within 48 hours — unless the fluid has been adequately drained and a management system is in place before joining the trial.
• People with uncontrolled blockage of the tubes draining the kidneys (ureterohydronephrosis) causing kidney failure — unless this is being adequately managed with a stent or catheter already in place before joining the trial.
• People who are not able to receive at least one of the three standard chemotherapy regimens used in the comparator arm of the trial, due to allergies, contraindications, or treatment history (the treating doctor must confirm this before enrolment).

Important: Always verify eligibility with the trial site directly before applying.