Phase 2 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:

• Adults aged 18 or older who are able and willing to sign a consent form and follow the trial requirements
• People who have been diagnosed with extranodal marginal zone lymphoma (a type of slow-growing blood cancer that starts outside the lymph nodes), confirmed by a tissue test, at any stage of the disease
• People who have not previously received treatment for this cancer — with some exceptions: those who received antibiotics for a stomach-related form of the cancer (H. pylori-positive gastric EMZL), or those who had local treatment such as radiation or surgery but never received whole-body (systemic) treatment and whose cancer has come back
• People who have a measurable area of disease visible on a scan (CT or MRI), taken within 6 weeks before starting treatment — with specific allowances for certain types of skin, stomach, or eye-related forms of the disease that may be assessed differently
• People willing to provide a tissue sample from a previous biopsy, or to have a new biopsy taken
• People whose cancer meets at least one condition requiring treatment, such as: risk to organ function, involvement of three or more lymph node areas each measuring 3 cm or more, a tumour measuring 5 cm or more, symptoms such as unexplained fever, night sweats, or significant weight loss, risk of organs being compressed by the tumour, an enlarged spleen or spleen lesions, certain low white blood cell counts caused by the lymphoma, high numbers of lymphoma cells in the blood, need for blood transfusions or growth factor support due to lymphoma, or involvement of two or more sites outside the lymph nodes
• People with a life expectancy of more than 3 months
• People with a reasonable level of physical functioning (able to carry out daily activities, even if not able to do heavy physical work)
• People with adequate blood counts, liver function, and kidney function based on blood tests done within 6 weeks before starting treatment (specific numerical thresholds apply — confirm with trial site)
• People willing to avoid pregnancy during the trial and for at least 90 days after the last dose

Who may not be able to join:

• People whose cancer has transformed into a more aggressive type of lymphoma called diffuse large B cell lymphoma (DLBCL)
• People with a history of lymphoma affecting the brain or spinal cord lining (though a specific type called Dural MZL may still be eligible — confirm with trial site)
• People who need urgent, immediate treatment to reduce their cancer quickly
• People who have received or are currently receiving any other cancer treatment, including chemotherapy, radiation, immunotherapy, or similar therapies
• People who have taken strong immune-suppressing medications within 2 weeks before starting the trial (some exceptions apply, such as low-dose steroids for unrelated conditions, inhaled steroids, or antibiotics for the stomach-related form of the cancer — confirm with trial site)
• People who have previously had a stem cell transplant (either from a donor or their own cells) or CAR-T cell therapy
• People currently experiencing graft versus host disease (a complication that can follow a donor transplant)
• People who have not sufficiently recovered from a major surgery
• People who have had another cancer within the past 3 years, unless it was a fully treated and cured form of certain low-risk cancers such as skin cancer, early-stage bladder cancer, or cervical carcinoma in situ
• People with serious uncontrolled medical conditions affecting the kidneys, liver, blood, digestive system, hormones, lungs, nervous system, or mental health
• People with a current or ongoing serious infection requiring antibiotics, antifungal, or antiviral treatment, or who had a serious infection requiring intravenous antibiotics within 4 weeks before starting
• People who received a live vaccine within 30 days before starting (some vaccines such as inactivated flu vaccines and approved COVID-19 vaccines are permitted)
• People known to be HIV positive (note: HIV testing is optional for this trial)
• People who have had a solid organ transplant (such as a kidney or liver transplant)
• People with a history of severe allergic reactions to certain types of antibody-based medicines
• People with known allergy to any ingredient in the trial medicines (mosunetuzumab or lenalidomide), including allergy to products made using Chinese hamster ovary cells or to mannitol
• People with serious heart conditions (such as a recent heart attack within 3 months, unstable heart rhythms, or severe heart failure) or serious lung conditions such as obstructive lung disease
• People with a known or suspected chronic active Epstein-Barr virus (EBV) infection
• People with a known or suspected history of a rare immune condition called hemophagocytic lymphohistiocytosis (HLH)
• People with a history of a brain condition called progressive multifocal leukoencephalopathy (PML)
• People with active hepatitis B infection (people with certain past hepatitis B markers may still be eligible if a specific blood test shows no active virus — confirm with trial site)
• People with active hepatitis C infection (people with hepatitis C antibodies may still be eligible if a specific blood test shows no active virus — confirm with trial site)
• People with a history of certain autoimmune diseases — though several exceptions may apply, including well-controlled or historic autoimmune conditions, thyroid conditions managed with stable hormone replacement, controlled Type 1 diabetes, certain blood-related autoimmune conditions, and mild skin conditions meeting specific criteria (confirm with trial site)
• People who have tested positive for COVID-19 within 7 days before enrolling

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