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 willing and able to give written consent to participate.
• People who are able to follow the requirements of the trial as described in the protocol.
• People who have been diagnosed with Marginal Zone Lymphoma (MZL) — specifically one of three subtypes: Extranodal MZL (EMZL), Nodal MZL (NMZL), or Splenic MZL (SMZL) — at any stage (I through IV), confirmed by tissue testing.
• People who have not previously received treatment for MZL — with some exceptions: those who received antibiotics for a stomach infection (H. pylori) linked to gastric MZL may still be considered eligible if MZL is confirmed after antibiotic treatment; and those who received only localised treatment (such as radiation or surgery) with no systemic treatment, and whose disease has returned, may also be considered eligible with tissue confirmation.
• People whose disease can be measured on imaging scans (PET/CT, CT, or MRI), with at least one tumour area measuring above a specific size — with special allowances for certain types such as skin, stomach, eye surface (conjunctival), and splenic MZL that may not show on standard imaging but can be measured or confirmed in other ways (confirm with trial site).
• People whose condition meets at least one specific reason to start treatment, such as: risk to organ function, involvement of three or more enlarged lymph node sites of significant size, a tumour mass larger than 5 cm, B symptoms (unexplained fever, night sweats, or significant weight loss), risk of pressure on nearby organs, an enlarged spleen or spleen-related blood count problems, low white blood cell count due to MZL, high numbers of lymphoma cells in the blood, need for blood transfusions or growth factor support, or involvement of two or more sites outside lymph nodes each measuring at least 1 cm.
• People with a life expectancy of more than 3 months.
• People with a general physical functioning level rated 0, 1, or 2 on a standard scale used in cancer trials (meaning able to carry out most daily activities, with or without some limitations).
• People whose blood, liver, and kidney function results fall within the required ranges when tested within 6 weeks before starting treatment (confirm specific values with trial site).
• People willing to avoid pregnancy during the trial and for at least 90 days after the last dose of the trial treatment.
• A tissue sample (biopsy) will be requested but not providing one does not automatically prevent participation — those with splenic MZL without available tumour tissue may provide a bone marrow biopsy instead (confirm with trial site).

Who may not be able to join:

• People whose MZL has transformed into a more aggressive type of lymphoma called DLBCL, or where there is strong clinical suspicion this has occurred.
• People with a history of lymphoma affecting the brain, spinal fluid, or central nervous system — though those with MZL involving the covering of the brain (dura) may still be eligible (confirm with trial site).
• People who have received or are currently receiving any anti-cancer treatment, including chemotherapy, radiation, immunotherapy, or similar therapies — with specific exceptions noted in the inclusion criteria.
• People who have taken strong immune-suppressing medications (such as prednisone above a certain dose, azathioprine, methotrexate, thalidomide, or anti-TNF agents) within 2 weeks before the start of the trial — with some exceptions for inhaled steroids, low-dose steroids for other conditions, and certain other specific medications (confirm with trial site).
• People who have previously had a bone marrow or stem cell transplant, or a type of immune cell therapy called CAR-T cell therapy, for any reason.
• People currently experiencing graft-versus-host disease (a complication sometimes seen after certain transplants).
• People who have not yet sufficiently recovered from a major surgery.
• People who have had another cancer within the past 3 years — with exceptions for certain fully treated, non-invasive skin cancers, early bladder cancer, certain prostate or cervical conditions, or other slow-growing non-invasive cancers (confirm with trial site).
• People with serious ongoing uncontrolled medical conditions affecting the kidneys, liver, blood, digestive system, hormones, lungs, nervous system, brain, or mental health.
• People with a current active infection requiring ongoing antibiotic, antifungal, or antiviral treatment, or who had a serious infection requiring intravenous antibiotics within 4 weeks before the start of the trial.
• People who have received a live vaccine within 30 days before joining, or who expect to need one during the trial — though standard flu shots (inactivated) and approved COVID-19 vaccines are permitted.
• People known to have HIV infection, or who test positive for HIV (note: HIV testing is optional in this trial).
• People who have had a solid organ transplant (such as a kidney, heart, or liver transplant).
• People with a history of serious allergic reactions (including anaphylaxis) to certain types of laboratory-made antibody treatments.
• People with a known allergy to the trial drugs (epcoritamab or lenalidomide) or to related substances, including those produced using a specific cell manufacturing process, or to thalidomide or mannitol.
• People with significant heart disease (such as severe heart failure, a heart attack within the last 3 months, or unstable heart rhythm or chest pain) or significant lung disease (such as severe obstructive lung disease or a history of bronchospasm).
• People with a known or suspected ongoing 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 serious brain condition called progressive multifocal leukoencephalopathy (PML).
• People with an active hepatitis B infection — those with certain hepatitis B test results may still be considered eligible under specific conditions involving additional blood tests and preventive antiviral treatment (confirm with trial site).
• People with active hepatitis C infection — those with a positive hepatitis C antibody test must have a negative viral PCR test to be considered eligible (confirm with trial site).
• People with a history of certain autoimmune diseases — though some people with well-controlled or historical autoimmune conditions (such as controlled thyroid disease, controlled Type 1 diabetes, certain skin conditions, or certain blood-related autoimmune conditions) may still be eligible under specific conditions as assessed by the treating doctor (confirm with trial site).
• People with a currently active COVID-19 (SARS-CoV-2) infection, or with symptoms suggesting current infection who have not tested negative — specific testing and timing requirements apply (confirm with trial site).
• People who are not able to make their own informed decisions about participation.

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