Phase 2 Lymphoma Trial, Recruiting

Written by an AI model from the 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 follicular lymphoma (grades 1 to 3A) confirmed by a tissue biopsy, where the lymphoma cells test positive for a protein called CD20. (Composite high-grade lymphoma is not included.)
• People who have at least one measurable area of lymphoma visible on a PET/CT scan at the time of joining the trial, where a lymph node meets specific size requirements and shows significant activity on the scan.
• People whose lymphoma was classified as Stage III or IV when first diagnosed.
• People who have received exactly one prior course of treatment (at least 3 cycles) that combined an anti-CD20 antibody medicine (such as rituximab or obinutuzumab) with chemotherapy (such as bendamustine, CHOP, CVP, or lenalidomide). Treatment with rituximab alone, rituximab plus radiation, or radiation alone does not meet this requirement.
• People whose best response to their first treatment was a partial response or stable disease — meaning the lymphoma did not grow or spread, but may not have completely disappeared.
• People who finished their last lymphoma treatment at least 4 weeks before starting this trial.
• People aged 18 years or older.
• People with a general health and activity level that meets the trial's physical functioning standard (confirm with trial site).
• People with a life expectancy of more than 2 years.
• People whose blood counts and organ function meet the trial's required levels, including adequate white blood cells, platelets, red blood cells, liver function, and kidney function (confirm specific values with trial site).
• People who have hepatitis B antibodies but an undetectable virus level while on antiviral treatment, provided they continue to take appropriate antiviral preventive medication during the trial.
• People who have hepatitis C antibodies but an undetectable virus level in their blood.
• People with a history of a different cancer, if that cancer was treated with the intent to cure, all treatment finished at least 2 years before joining this trial, and there is currently no sign of that cancer returning.
• People whose side effects from previous treatment have resolved to mild or no symptoms, with the exception that moderate nerve-related symptoms (such as numbness or tingling) or hair loss of any degree are still acceptable.
• People who are able to understand the trial and are willing to sign a consent form.
• Women who could become pregnant must agree to use a highly effective form of birth control throughout the trial. Accepted methods include hormonal contraception (pill, injection, or implant), an intrauterine device (IUD or IUS), a partner who has had a vasectomy, or complete abstinence that is consistent with their normal lifestyle.
• Women must agree not to donate eggs during the trial and for 12 months after their last dose of the trial treatment.
• Men must agree not to donate sperm during the trial and for 12 months after their last dose of the trial treatment.
• 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) during the trial and for 12 months after their last dose of the trial treatment.

Who may not be able to join:

• People whose previous lymphoma treatment included an experimental or investigational drug as part of their initial therapy.
• People who have an active, uncontrolled infection that required hospitalisation or intravenous antibiotics within 4 weeks before starting the trial.
• People with serious, uncontrolled heart conditions, such as severe heart failure, unstable chest pain, a heart attack within the past 6 months, or a heart pumping function below 45%, or a serious heart rhythm problem.
• People with an uncontrolled neurological (brain or nervous system) condition, such as a seizure disorder, stroke, psychosis, dementia, brain blood vessel inflammation, or brain infection.
• People who need supplemental oxygen at rest to maintain adequate blood oxygen levels.
• People who have taken immune-suppressing medications (including steroid medicines at doses of 10 mg per day or more of prednisone or equivalent) for a reason unrelated to lymphoma within 28 days before starting treatment, or for lymphoma-related reasons within 10 days before starting treatment.
• People with known or suspected lymphoma involvement in the brain or spinal fluid.
• People with a history of brain cancer from a separate cancer, unless treatment for that cancer is complete and there is currently no sign of disease.
• People who are pregnant or breastfeeding, or people who are unwilling to follow the trial's birth control requirements.
• People with a known current problem with alcohol or drug misuse, a psychiatric illness, or an unstable living situation that is likely to make it difficult to follow the trial's requirements.
• People who have had a serious allergic reaction to medicines that are chemically or biologically similar to the trial treatment (epcoritamab).
• People who have received a live or live-attenuated vaccine within the 4 weeks before starting the trial.
• People living with HIV.

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