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 diffuse large B-cell lymphoma (a type of blood cancer) confirmed by a tissue sample, and who plan to be treated at Moffitt Cancer Center.
• People who are able to understand the study and are willing to sign a written consent form agreeing to take part.
• People whose doctors have determined them to be eligible to receive a specific type of immune cell therapy called CAR T-cell therapy (axicabtagene ciloleucel) for their type of lymphoma, as approved under standard medical guidelines.
• People who have a general health status rated as 0, 1, or 2 on a standard medical scale (meaning they are fully active to somewhat limited in strenuous activity, but able to carry out light work) (confirm with trial site).
• People who have at least one area of disease measuring 5 cm or larger that the treating doctor determines can be targeted with radiation therapy.
• People who are able to receive radiation treatment to all visible areas of disease in the body.
• People with no signs or suspicion of the lymphoma having spread to the brain or spinal cord.
• People whose bone marrow and organ function meet the levels required by the study (confirm with trial site for specific values).
• Men who agree to use highly effective contraception (at least 99% effective) from the start of screening through the safety follow-up period, and who agree not to donate sperm during this time.
• Women who could become pregnant, who have a negative pregnancy test at screening and before radiation planning, and who agree to use highly effective contraception (at least 99% effective) from screening through the safety follow-up period.
• Women who cannot become pregnant — meaning those who have had a hysterectomy and/or both ovaries removed, or who have had no menstrual period for 12 months or more.

Who may not be able to join:

• People who are currently taking part in another clinical trial, or who have received an experimental treatment within the 4 weeks before screening.
• People who have previously received CAR T-cell therapy.
• People for whom the treating radiation specialist determines it would not be safe to deliver radiation to all areas of disease.
• People with serious or poorly controlled heart conditions, including unstable chest pain, a heart attack within the past 6 months, severe heart failure, or a condition requiring medications to maintain blood pressure or heart function.
• People with irregular heart rhythms that have not been stable on medication within 2 weeks of screening.
• People with an active infection (from any cause — viral, bacterial, fungal, or other) that is not controlled or treated.
• People who have a known positive HIV diagnosis.
• People with active or ongoing hepatitis B infection, unless the virus level is undetectable while on appropriate treatment.
• People with a history of hepatitis C infection, unless testing shows the virus has been cleared — either after treatment or on its own.
• People who need to take ongoing steroid medications or other immune-suppressing drugs on a regular basis (note: certain steroids used around a specific part of the treatment process may be permitted — confirm with trial site).
• People who have any condition that, in the treating doctor's opinion, would prevent full participation, create significant risk, or make it difficult to interpret the study results.
• People who, in the treating doctor's opinion, are unlikely to complete all required visits, procedures, or study requirements — including radiation planning and treatment.
• Women who are pregnant or breastfeeding.

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