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 read, understood, and voluntarily signed and dated a consent form before any study-related assessments begin
• Adults aged 18 or older (there is no upper age limit)
• People whose doctors have determined them to be eligible for an approved anti-CD19 CAR T-cell therapy (a type of immune cell treatment for blood cancer)
• People with a performance status of 0, 1, or 2 — meaning they are fully active, or able to carry out light work, or able to care for themselves but unable to work (confirm with trial site)
• People diagnosed with an aggressive large B-cell lymphoma, which includes: diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, transformed follicular or marginal zone lymphoma, or high-grade B-cell lymphoma. People whose lymphoma has spread to the brain may be included, but not those with primary CNS (brain) lymphoma
• People who have a tissue sample (biopsy) available for review by the central study team
• People for whom the CAR T-cell treatment has been approved by a multidisciplinary medical team, as a second, third, or fourth treatment attempt for their lymphoma
• People whose tumour volume — measured by a special type of scan called an FDG-PET scan done just before starting the CAR T-cell process — is greater than 80 ml, as confirmed by the central review team
• People whose kidneys are functioning above a minimum threshold level, based on a standard blood test result (confirm with trial site for specific values)
• People whose liver is functioning within acceptable levels based on blood tests, with slightly different thresholds allowed if the lymphoma has affected the liver, or if a specific liver condition called Gilbert's syndrome is present
• People covered by the French social security system (this trial is based in France)
• People who can understand and speak an official language of the country where the trial is taking place, unless local rules allow for an independent translator
• Women who could become pregnant must agree to use two reliable methods of contraception (including at least one highly effective method), or to abstain from heterosexual intercourse, from the time of signing consent, throughout treatment, and for at least 28 days after the last dose of the study drug golcadomide. They must also agree not to donate eggs during this period

Who may not be able to join:

• People who have had another cancer (other than certain minor skin cancers or early-stage cancers that were fully treated) unless they have been free of that cancer for at least 3 years
• People with an active or uncontrolled infection currently requiring intravenous (IV) antibiotics or antifungal treatment (some minor infections that are responding to treatment may be acceptable — confirm with trial site)
• People with a history of HIV infection, or active hepatitis B or C infection; people with a past hepatitis infection may be considered if standard tests confirm the infection has fully cleared
• People with significantly reduced lung function or blood oxygen levels below 92% while breathing normal room air
• People with serious heart disease classified as New York Heart Association Class III or IV (confirm with trial site for full details)
• People who have had a heart attack, heart procedure (such as angioplasty or stenting), unstable chest pain, or another significant heart condition within the 6 months before joining the trial
• People who have had a severe allergic reaction to any of the treatments used in this study
• People currently taking strong medications that significantly affect a liver enzyme called CYP3A4/5 (confirm with trial site for a full list of affected medications)
• Women who are pregnant, planning to become pregnant, or currently breastfeeding
• People with a significant medical condition, abnormal test result, or mental health condition that the investigator believes would interfere with participation in the trial
• People whose freedom is restricted by a legal or administrative decision
• People who are hospitalised without their own consent
• Adults who are under a legal protection order

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