Phase 3 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 a healthy immune system and have been newly diagnosed with a specific type of aggressive blood cancer (called diffuse large B-cell lymphoma, or DLBCL) located in the brain or central nervous system (CNS).
• People aged over 70, or aged 65–70 if a doctor has determined that more intensive treatments are not appropriate for them.
• People whose diagnosis has been confirmed by a pathologist (a specialist who examines tissue or cell samples) through laboratory testing.
• People whose diagnosis was confirmed using one of these methods: a brain biopsy, a spinal fluid sample, or a surgical procedure on the eye called a vitrectomy.
• People whose cancer is found only in the CNS, with no spread to other parts of the body.
• People who have at least one measurable area of disease that can be tracked during the trial.
• People whose general physical functioning is rated at a certain level on a standard medical scale (called ECOG Performance Status of 2 or below), though a lower functioning score may be accepted if it is caused by the CNS lymphoma itself (confirm with trial site).
• People whose treating doctor considers them to potentially be suitable for a type of stem cell transplant procedure.
• People who have given written agreement to take part, or whose legal representative has done so if the person is temporarily unable to make that decision due to their illness.

Additional criteria required before being assigned to a specific treatment group:

• People who meet specific fitness criteria for stem cell transplant, based on a combination of physical functioning scores and a geriatric screening tool — at most one of three specific health conditions may apply (confirm with trial site for exact scoring details), or who have shown improvement after an initial treatment phase, or whose doctor — in discussion with the study expert team — judges them to be suitable.
• People who show no signs of their cancer getting worse after an initial treatment phase.

Who may not be able to join:

• People with a weakened immune system, whether from birth or due to a condition such as HIV infection, or who have previously had an organ transplant.
• People whose lymphoma has spread to parts of the body outside the CNS.
• People whose lymphoma is found only in the eye (vitreoretinal lymphoma) or only in the lining of the brain (leptomeningeal lymphoma) without any involvement of the brain tissue or spinal cord.
• People who have had another cancer in the past or currently, unless it was completely cured by surgery (such as a very early-stage skin or cervical cancer) or unless there has been no sign of any other cancer for at least 5 years.
• People who have previously had a type of blood cancer called Non-Hodgkin lymphoma at any point in the past.
• People whose kidneys are not working well enough, based on a specific measurement of kidney function (confirm with trial site for exact threshold).
• People whose bone marrow, heart, lungs, or liver are not functioning adequately, as determined by the treating doctor.
• People with an active hepatitis B or hepatitis C infection.
• People who are currently taking part in another clinical trial involving an experimental treatment, or who have done so within the past 30 days.
• People who have a significant build-up of fluid in body cavities (more than 500 ml) (confirm with trial site).
• People who have a known allergy or sensitivity to the trial treatment or any of its ingredients.
• People who are taking medications that are likely to interact with the trial treatment.
• People with a known or ongoing problem with misuse of medications, recreational drugs, or alcohol.
• People with an active COVID-19 infection, or who are not following the relevant hygiene guidelines related to COVID-19.
• People who are unable to understand the nature and consequences of the trial and who do not have a designated legal representative to act on their behalf.
• People who have previously taken part in this trial.
• People who have an employment or dependency relationship with the organisation running or investigating the trial.
• People whose family situation, social circumstances, or location may make it difficult to follow the trial schedule and attend required visits.
• People of childbearing potential who are unwilling to use reliable contraception throughout the trial.

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