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 diagnosed with a specific type of large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma with certain gene changes, EBV-related DLBCL, primary mediastinal B-cell lymphoma, T-cell/histiocyte rich large B-cell lymphoma, grade 3B follicular lymphoma, or large B-cell lymphoma that developed from a previously existing slow-growing lymphoma.
• People whose lymphoma is detectable on a PET scan, as measured by standard criteria called the Lugano criteria.
• People whose lymphoma has come back or stopped responding to treatment, and who have received exactly one prior round of systemic treatment that included both an anti-CD20 antibody (a type of targeted therapy) and either an anthracycline or an alkylating agent (types of chemotherapy).
• People aged 18 years or older.
• People with a general health and activity level rated 0, 1, or 2 on a standard scale used by doctors (ECOG scale), meaning they are reasonably functional in daily life.
• People who, in their treating doctor's opinion, are not suitable candidates for high-dose chemotherapy followed by a stem cell transplant using their own cells, or people who have chosen not to have that treatment.
• People whose blood counts meet minimum levels set by the trial, including sufficient white blood cells, platelets, and haemoglobin (confirm with trial site for exact values, as some flexibility exists for certain conditions).
• People with adequate liver, kidney, and blood clotting function, unless any abnormalities are caused by the lymphoma itself (confirm with trial site for specific thresholds).
• People who are able to stay within 60 minutes of the treatment site for 24 hours after a specific dose during the first treatment cycle.
• Women who could become pregnant and who agree to use two forms of contraception from the first dose until at least 6 months after the last dose, and who agree not to donate eggs during that period.
• Women who cannot become pregnant, defined as being 45 or older with no menstrual period for at least 12 consecutive months, or having had both ovaries removed, or having had a tubal ligation (with supporting medical records), or having hormone levels confirmed by blood tests showing they are no longer fertile.
• Women who could become pregnant and who have a negative pregnancy blood test at the start of the trial (screening).
• Men who are capable of fathering children and are sexually active with a female partner who could become pregnant, and who agree to use contraception from the first dose until 3 months after the last dose, and who agree not to donate sperm during that period.
• People who are able to understand the study and willing to sign an informed consent form, or who have a legally authorised representative to do so on their behalf.

Who may not be able to join:

• People who have taken an investigational drug or any approved lymphoma treatment within 28 days before the first dose (steroids used to control lymphoma symptoms are allowed if stopped at least 7 days before the first dose).
• People who have previously been treated with a CD20/CD3 bispecific antibody (a specific type of combination targeted therapy).
• People who have previously had an autologous or allogeneic stem cell transplant (using their own or a donor's stem cells).
• People who have previously received CAR T-cell therapy targeting CD19.
• People who have not fully recovered from side effects of prior cancer treatment (side effects above a mild level), with the exception of hair loss — though the lead investigator may consider exceptions in certain cases (confirm with trial site).
• People whose lymphoma has spread to the central nervous system (brain or spinal cord).
• People with a serious or life-threatening medical condition or organ problem (unrelated to lymphoma) that, in the investigator's opinion, could put them at risk — though people with mild memory or thinking difficulties may still be considered eligible at the investigator's discretion.
• People with an active, uncontrolled infection (minor fungal infections of the skin or nails are allowed).
• People with an active, uncontrolled autoimmune disease — though autoimmune conditions managed with low-dose steroids (up to 10 mg per day of prednisone or equivalent) may still be eligible.
• People with a history of serious allergic reactions to medicines with a similar makeup to the study drug, epcoritamab (a history of a reaction to anti-CD20 therapy is not considered disqualifying).
• People who are currently pregnant, as the effects of epcoritamab on an unborn baby are unknown.
• People who are currently breastfeeding, as there is an unknown potential risk to nursing infants.
• People with HIV that is not well controlled — though people with HIV whose virus is undetectable, who have a CD4 count above 350, and who have no active AIDS-related illnesses may still be eligible if managed on appropriate treatment.
• People with active hepatitis B infection — though people with certain positive hepatitis B markers may still be eligible if the virus is undetectable by a specific blood test and they are on appropriate antiviral treatment.
• People with active hepatitis C infection — though people with past hepatitis C that has resolved may be eligible if a confirmatory blood test shows the virus is no longer present.
• People with a known active COVID-19 (SARS-CoV-2) infection, or people with recent symptoms or known exposure who have not yet tested negative (confirm with trial site regarding local testing requirements).
• People who have received a live virus vaccine within 28 days before the first dose.
• People with a current or past cancer other than the lymphoma being treated, with some exceptions including: early-stage cervical cancer (Stage 1B or lower), non-invasive skin cancers, non-invasive superficial bladder cancer, prostate cancer with very low PSA levels, or any other cancer that was fully treated and in complete remission for more than 2 years.

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