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 aged 18 or older
• People who have been diagnosed through a tissue biopsy with one of the following: Diffuse large B-cell lymphoma (not otherwise specified), High-grade B-cell lymphoma (including types with MYC and BCL2 gene rearrangements), or T cell/histiocyte-rich large B-cell lymphoma
• People who have not yet received any systemic (whole-body) treatment for their current lymphoma
• People who are considered unsuitable for standard chemotherapy containing anthracyclines (a type of chemotherapy drug) for one or more of the following reasons: they are aged 80 or older; they are assessed as "unfit" or "frail" based on a specific geriatric health assessment tool; their heart pumping function (ejection fraction) is between 30% and below 50%; they have had previous cancer treatment with anthracycline drugs that affected their heart; or they have mild to no heart failure symptoms (confirm with trial site for exact assessment)
• People with stage II (with a large tumour over 7cm), stage III, or stage IV lymphoma
• People with a performance status score of 2 or lower on the ECOG scale (a measure of how much the illness affects daily activity), or up to 3 if the reduced score is caused by the lymphoma itself and improves to 2 or below after an initial pre-treatment phase
• People whose lymphoma is measurable on scans, with at least one affected lymph node measuring 1.5 cm or more, or one affected area outside lymph nodes measuring more than 1 cm
• People whose blood counts and organ function meet the following levels (as measured by blood tests): a neutrophil count of at least 1.0 × 10⁹/L; a platelet count of at least 75 × 10⁹/L; bilirubin at or below 3 times the upper normal limit (unless due to a known harmless condition called Gilbert's syndrome); liver enzymes AST and ALT no more than 3 times the upper normal limit; alkaline phosphatase below 2.5 times the upper normal limit; and kidney function (creatinine clearance) above 45 ml/min
• People who are willing and able to sign a consent form after being fully informed about the study
• People who have the mental capacity to make their own decisions about participation
• People who agree not to donate blood during the study treatment and for at least 12 months after the last dose
• Women who are breastfeeding must agree to stop breastfeeding during the study and for at least 12 months after the last dose of the study drug epcoritamab
• Women who could become pregnant must have a negative pregnancy test before starting the study, agree to regular pregnancy testing during the study, and agree to use two forms of contraception (one highly effective method and one barrier method) from 28 days before starting treatment until at least 12 months after the last dose, or agree to complete abstinence from sexual activity for the entire period
• Men who are sexually active with a woman who could become pregnant must agree to use a barrier method of contraception (such as a condom with spermicide) from the time of signing consent until at least 12 months after the last dose, even if they have had a vasectomy, and must agree not to donate sperm during treatment and for at least 12 months after the last dose

Who may not be able to join:

• People whose lymphoma has spread to the brain or the fluid surrounding the brain and spinal cord
• People who have had another type of cancer in the past, unless they have been cancer-free for 3 or more years and their treating doctor considers the risk of it returning to be low — exceptions include fully treated localised skin cancer or treated cervical pre-cancer (carcinoma in situ), both with no current signs of disease
• People with any serious illness, medical condition, or organ problem that, in the investigator's opinion, could put their safety at risk or affect the study results
• People with uncontrolled HIV, active Hepatitis C, active Hepatitis B, or any other serious uncontrolled active infection, including suspected or confirmed JC virus infection or active COVID-19 (SARS-CoV-2)
• People with certain Hepatitis B or C blood markers indicating active or detectable virus (confirm specific marker thresholds with trial site)
• People with a history of severe allergic reactions or intolerance to treatments that target a protein called CD20, or to any bispecific antibody therapy
• People with a history of immune system deficiency (other than low antibody levels) or who have been taking strong immune-suppressing medications within 28 days before the first dose (with some exceptions, such as inhaled, topical, or low-dose steroid use)
• People with significant heart problems such as uncontrolled or symptomatic irregular heartbeat, severe heart failure, or a heart attack within the past 6 months, or who have moderate to severe heart disease as classified by standard heart failure guidelines — people with controlled and symptom-free heart failure may still be considered
• People with certain significant abnormalities on a heart tracing (ECG), including specific types of electrical conduction problems or a prolonged QTcF interval above 470 milliseconds
• People who have had a stroke, seizure disorder, are taking anti-seizure medication, or have had bleeding in the brain within 6 months before joining the study
• People with more than a mild fluid collection around the heart (pericardial effusion), confirmed by heart ultrasound (echocardiogram)
• People who are pregnant or currently breastfeeding
• People who have received any other experimental treatment within 28 days before the first dose
• People who have had major surgery within 28 days, or minor surgery within 3 days, before the first dose
• People who are regularly taking corticosteroids (steroid medications) for other conditions at a dose equivalent to 10 mg/day or more of prednisone — note that steroids are permitted at any dose if used to control lymphoma symptoms or to manage side effects during the trial
• People with a life expectancy of less than 6 months
• People with nerve damage (neuropathy) worse than mild (greater than Grade 1)
• People who have previously received the study drug epcoritamab for any reason
• People with an active autoimmune disease that has required systemic medical treatment (such as immune-suppressing drugs or high-dose steroids) within the past 2 years — hormone replacement therapies such as thyroid medication or insulin are not considered systemic treatment and are permitted
• People who have a history of non-infectious lung inflammation (pneumonitis) that required steroid treatment, or who currently have pneumonitis

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