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 aggressive large B-cell lymphoma (a blood cancer) that has not yet been treated, and where the treating doctor considers a chemotherapy regimen called DA-EPOCH-R to be the appropriate standard treatment.
• People whose lymphoma falls into one of several specific subtypes, including double/triple-hit lymphoma, diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, Burkitt lymphoma, or several other related types, as classified under international diagnostic guidelines.
• People who are planned to receive a full course of six cycles of chemotherapy plus immunotherapy as part of standard care (up to one cycle already received may be allowed in certain circumstances).
• People aged 18 or older at the time of signing the consent form.
• People who are willing and able to sign a written consent form agreeing to take part in the trial.
• People who have measurable disease — meaning at least one lymph node site measuring 1.5 cm or one site outside the lymph nodes measuring 1.0 cm, as seen on a CT or PET scan.
• People whose general physical functioning is rated at 0, 1, or 2 on a standard medical scale used to measure how well a person can carry out daily activities (confirm with trial site).
• People whose heart is pumping at 50% or above, as measured by a heart scan (MUGA or echocardiogram).
• People whose blood counts and organ function meet specific minimum levels, including white blood cells, platelets, haemoglobin, kidney function, and liver function — individual thresholds apply and some exceptions exist if the lymphoma itself is affecting the bone marrow (confirm with trial site).
• People whose blood clotting tests are within acceptable ranges, or who are on blood thinning medication with clotting levels within the intended treatment range.
• Women who could become pregnant must agree to use highly effective contraception (with a failure rate of 1% or less per year) or remain abstinent during treatment and for at least 12 months after the last dose, and must also agree not to donate eggs during this period.
• Women who could become pregnant must have a negative blood pregnancy test during the screening period.
• Men with female partners who could become pregnant, or who are pregnant, must agree to use a condom or remain abstinent during treatment and for at least 6 months after the last dose, and must agree not to donate sperm during this period.

Who may not be able to join:

• People who have a medical reason preventing them from receiving any of the individual components of the EPOCH-R chemotherapy regimen, including those with a history of severe allergic reactions to certain antibody-based treatments, or those for whom receiving additional doses of a drug called an anthracycline would exceed the safe lifetime limit.
• People who have previously received systemic (whole-body) treatment for lymphoma, with limited exceptions for steroid use or one prior cycle of chemotherapy given urgently before the study started.
• People who have previously received an organ transplant.
• People who currently have moderate or severe nerve damage (peripheral neuropathy) or a specific inherited nerve condition called Charcot-Marie-Tooth disease.
• People who have a history of another cancer that could interfere with the trial, with some exceptions — for example, certain skin cancers treated with curative intent, other cancers that have been in remission without treatment for two or more years, or low-grade early-stage prostate cancer not requiring treatment, may still be eligible.
• People with serious uncontrolled health conditions, particularly heart conditions such as severe heart failure, heart attack in the past six months, unstable irregular heartbeat, or unstable chest pain, or significant lung disease.
• People who have had a major surgical procedure within the four weeks before starting the trial (except surgery done to obtain a diagnosis).
• People with certain abnormal heart rhythm findings on an ECG that the doctor considers clinically significant, including specific types of heart block or signs of a heart attack in the past six months.
• People who have an active infection requiring systemic treatment that has not been fully treated by the time treatment begins, including those with current or recent COVID-19 infection who do not meet specific testing requirements.
• People who test positive for active hepatitis B infection, though those with past or hidden hepatitis B infection may be eligible if the virus is undetectable and they agree to regular monitoring and treatment if needed.
• People who test positive for hepatitis C antibodies, unless a further test shows no active hepatitis C virus in the blood.
• People with HIV that is not well controlled; those with a known HIV diagnosis may be eligible only if their viral load is undetectable and they are on anti-retroviral therapy.
• People with a history of a serious brain condition called progressive multifocal leukoencephalopathy.
• People with known active lymphoma affecting the central nervous system (brain or spinal cord).
• People whose treatment would require high-dose intravenous methotrexate given mid-cycle to protect the brain and spinal cord, in the opinion of the treating doctor.
• People who are pregnant, breastfeeding, or planning to become pregnant during the study.

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