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:

• You are 18 years of age or older
• You are able to understand and sign a consent form agreeing to take part
• You have been diagnosed with cutaneous T-cell lymphoma (CTCL), confirmed by a tissue sample (biopsy)
• Your disease is at Stage 1b or higher
• You have already tried at least 2 different systemic (whole-body) treatments for your condition, and they either did not work or you could not tolerate them
• Your disease can be measured or tracked using at least one recognised method, assessed within 28 days before starting treatment
• You are on a low, stable dose of steroid medication (such as prednisone under 10mg, or an equivalent), or a stable topical (skin-applied) steroid — both are allowed
• Enough time has passed since your last cancer treatment (at least 2 weeks, or 4 weeks for certain antibody-based treatments, or 5 half-lives of the drug — whichever is longer)
• You have tested negative for a virus called HTLV-1
• You are reasonably active and able to care for yourself (confirm with trial site)
• Your life expectancy is 3 months or more
• Your bone marrow, liver, kidney, and blood clotting functions are all at adequate levels
• If you have HIV, you are on a stable HIV treatment for at least 4 weeks and your viral levels are well controlled (below 400 copies/mL)
• If you are male, you agree to use highly effective contraception during treatment and for at least 3 months after your last dose, and to avoid donating sperm during this time
• If you are a woman who could become pregnant, you are not currently pregnant or breastfeeding, and you agree to use highly effective contraception (or remain abstinent) from the time of consent, throughout treatment, and for at least 3 months after your last dose
• If you are a woman who could become pregnant, you have a negative pregnancy blood test within 72 hours before your first dose
• You are willing and able to follow all study requirements as assessed by the trial doctor

Who may not be able to join:

• Your lymphoma has spread to the brain or spinal cord
• You are currently taking certain medications that strongly affect how the body processes drugs (known as strong CYP enzyme inhibitors or inducers, or certain drug transporters) — though you may still be eligible if you can stop these medications at least 14 days or 5 half-lives before starting the trial treatment (confirm with trial site)
• You have significant heart disease, a history of lung disease affecting the tissue between the air sacs, or severely reduced lung function
• You have an active infection (viral, bacterial, or fungal) that requires ongoing treatment — routine preventative antibiotics are allowed
• You have been diagnosed with another cancer within the past 5 years (exceptions may apply for certain skin cancers that have been fully treated with no signs of return)
• You are currently taking or have recently taken (within 4 weeks) a drug that affects the immune system for another condition
• You have active hepatitis (liver inflammation caused by a virus) — some people with a history of hepatitis B or C may still be eligible depending on their viral levels, and should be discussed directly with the trial team (confirm with trial site)
• You have any other medical condition, abnormal lab result, or circumstance that the trial doctor believes could affect the study results or your ability to participate fully
• You have previously had a bone marrow or stem cell transplant (from a donor or your own cells)
• You have a known psychiatric (mental health) condition that would make it difficult to follow the study requirements
• You currently use recreational or illegal drugs, or have had a problem with drug or alcohol use in the past year, in a way that the trial doctor believes would affect your ability to follow the study requirements

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