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:

• People who have been diagnosed with a specific type of lymphoma — either follicular lymphoma (grade 1–3A) or marginal zone lymphoma (any subtype) — confirmed by a tissue sample reviewed at one of the participating hospitals, and who do not currently have signs that the lymphoma has transformed into a more aggressive type
• People who have already received at least one previous treatment for their lymphoma, which must have included a CD20-targeting antibody therapy (a type of immunotherapy)
• People who have measurable disease visible on scans (PET, CT, or MRI), meaning at least one lesion of a certain minimum size, or an enlarged spleen; for follicular lymphoma, the disease must show up on a PET scan in a specific way (confirm with trial site)
• People whose disease meets at least one reason to start treatment, such as: lymph node swelling causing symptoms, organ problems caused by the lymphoma, persistent fevers, night sweats, or significant unintentional weight loss, a tumour mass larger than 7 cm, more than three enlarged lymph node sites, symptoms caused by the disease pressing on nearby structures, a very enlarged spleen, fluid build-up around the lungs or abdomen, cancer cells circulating in the blood above a certain level, rapidly worsening disease, kidney involvement, or bone lesions
• People who are reasonably well and able to carry out daily activities, as measured by a standard health scale (ECOG score of 0, 1, or 2)
• People aged 18 years or older
• People whose blood counts and organ function meet minimum required levels (including white blood cell counts, platelet counts, kidney function, liver function, and bilirubin levels) — specific thresholds apply and will be checked by the trial team
• People who are willing and able to give written informed consent to participate
• People who are willing to provide a tumour tissue sample before treatment starts, either from a new biopsy or an archived sample collected within the past 90 days without any treatment in between (exceptions may be considered by the trial team)
• People who are willing to use highly effective contraception or remain abstinent for a specified period after treatment ends — at least 12 months after certain study drugs, depending on which drug was last received; this applies to both males and females (specific contraception requirements will be explained by the trial site)

Who may not be able to join:

• People who need ongoing medication that suppresses the immune system, or who are taking corticosteroid medicines at a dose higher than 10 mg of prednisone (or equivalent) per day — short-term use for symptom relief may be allowed, but steroids must be stopped before treatment begins
• People with large, swollen lymph nodes in the neck area that are pressing on or could block the airway
• People who have had major surgery or a serious injury within 4 weeks before starting the study, or who have not yet fully recovered from a major surgery
• People with a positive hepatitis C antibody test, unless the hepatitis C virus is undetectable in the blood at a specified level of sensitivity — people with detectable virus may still be considered if they agree to regular monitoring (confirm with trial site)
• People with certain positive hepatitis B test results, unless the hepatitis B virus is undetectable in the blood at a specified level of sensitivity — those with undetectable virus may still participate if they receive preventative antiviral medication and agree to regular monitoring (confirm with trial site)
• People with a known active infection (bacterial, viral, fungal, or other) requiring antibiotic or antifungal treatment at the time of joining, or a significant infection within 2 weeks before starting study treatment
• People with a known active COVID-19 infection — people with recent symptoms or known exposure must have negative test results before being considered (confirm with trial site)
• People who have had another cancer in the past, unless they have been cancer-free for at least 2 years, or unless the previous cancer was a minor skin cancer, early-stage cervical or breast cancer, or a low-risk prostate cancer being monitored without treatment
• People who have received a live vaccine within 28 days before the first dose of study treatment, or who are expected to need one during the study
• People with severe or uncontrolled health conditions that could affect their ability to safely participate or follow the study requirements
• People who have had, in the past 6 months or currently: a heart attack, certain heart rhythm problems, unstable chest pain, heart bypass surgery, a serious irregular heartbeat (at a certain severity level), or a stroke; or who have a history of certain heart conduction problems without a permanent pacemaker; or who have uncontrolled high blood pressure above specified levels
• People with severe heart failure (New York Heart Association Class III or IV), a known very low heart pumping function (ejection fraction below 45%), a heart attack within 6 months, unstable chest pain within 3 months, or a history of serious heart rhythm problems within 6 months
• People who are unable to follow the requirements of the study
• People who are pregnant, breastfeeding, or planning to become pregnant during the study
• People who have previously had a solid organ transplant or a bone marrow/stem cell transplant from a donor
• People with a known or suspected history of a serious immune-related condition called haemophagocytic lymphohistiocytosis (HLH)
• People with a history of significant autoimmune diseases (such as lupus, rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease, myositis, and others) — people with a past or well-controlled autoimmune condition may be considered after discussion with the trial team
• People who have had a severe reaction to anti-CD20 antibody therapy, or who are known to be allergic or intolerant to the study drug epcoritamab or any of its ingredients
• People with lymphoma that has spread to the brain or spinal cord
• People with nerve damage or neuropathy above a mild level (grade 1)
• People who have received CAR-T cell therapy within 100 days before the first study dose
• People who have received another investigational (experimental) drug within 4 weeks before the first study dose
• People who have received chemotherapy or other cancer treatments (other than CD20 antibody therapy) within 4 weeks before the first study dose
• People who require warfarin or similar blood-thinning medications — other types of blood thinners (such as apixaban, rivaroxaban, or low-molecular-weight heparin) are allowed
• People who need to take medications that are known to strongly interfere with the breakdown of one of the study drugs (strong CYP3A inducers) — the trial team will review current medications at enrolment
• People who are unable to swallow capsules, or who have significant problems with absorbing food or medication through the digestive system
• People with a history of severe bleeding disorders such as haemophilia A, haemophilia B, or von Willebrand disease, or a history of serious bleeding requiring transfusions or medical treatment
• People who have previously been treated with a BTK inhibitor (a specific type of targeted cancer therapy)
• People whose disease did not respond to, or progressed within 6 months of, a prior treatment with a specific type of antibody therapy called a CD3xCD20 bispecific antibody — a limited number of such patients may still be enrolled depending on availability in each group (confirm with trial site)
• People whose heart electrical activity test (ECG) shows a specific measurement (QTcF interval) above 480 milliseconds
• People who have had a stroke or bleeding in the brain within 6 months before the first study dose
• People who have had major surgery within 4 weeks before the first study dose, or who have planned major surgery during the study

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