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 aged 18 to 70 years old (any gender).
• People who have been diagnosed through laboratory testing with peripheral T-cell lymphoma that has come back or stopped responding to treatment.
• People whose lymphoma returned or stopped responding after at least one previous course of treatment delivered throughout the body, and who have not previously been treated with a type of drug called an HDAC inhibitor. People with NK/T-cell lymphoma must have previously received a treatment containing asparaginase/protease, and people with CD30-positive ALCL must have previously received a drug called Brentuximab vedotin.
• People who have previously had radiotherapy may still be considered, though radiotherapy alone does not count as a prior systemic treatment for the purposes of this trial.
• People who have at least one area of disease that can be measured on scans or tests.
• People who are willing to provide either stored tumour tissue samples or freshly collected tumour tissue samples that meet the trial's requirements.
• People who are expected to live for at least 12 weeks.
• People who are generally well enough to carry out light activity and care for themselves, as measured by a standard scale used by doctors (ECOG score of 0 or 1).
• People whose heart, liver, kidneys, and other organs are working well enough, as confirmed by blood tests and other assessments.
• Women who could become pregnant must have a negative pregnancy test within 7 days before the first dose. Women who have not been surgically sterilised must agree to use reliable contraception throughout the trial and for 6 months after the last dose. Men whose partner could become pregnant must agree to use effective contraception throughout the trial and for 6 months after the last dose, and must not donate sperm during this period.
• People who are able to give written consent before any trial activities begin.

Who may not be able to join:

• People who have previously been treated with a type of drug known as an EZH2 inhibitor or EZH1/2 inhibitor.
• People who have previously been treated with an HDAC inhibitor.
• People who are known to have an allergy or sensitivity to the study drug or any of its ingredients.
• People who received chemotherapy, immunotherapy, radiotherapy, or targeted therapy within 4 weeks (or within 5 half-lives of the drug, whichever is shorter) before the first dose; received CAR-T cell therapy within 12 weeks before the first dose; or received an autologous stem cell transplant within 3 months before the first dose.
• People who received another experimental anti-cancer treatment within 28 days before the first dose of the study drug.
• People who had major surgery within 4 weeks before the trial starts, or who are expected to need major surgery during the trial (minor procedures such as biopsies are generally acceptable — confirm with trial site).
• People who have had an allogeneic (donor) stem cell transplant or a solid organ transplant.
• People who received high-dose steroid treatment (above a certain level) or other immune-suppressing medicines within 14 days before the first dose. Low-dose steroids, inhaled or skin-applied steroids, and replacement steroid therapy at or below a certain dose may be permitted (confirm with trial site).
• People taking certain medicines known to strongly affect how the body processes drugs (strong CYP3A4 inhibitors or inducers, or P-glycoprotein inhibitors) within 14 days before the first dose.
• People who received a live virus vaccine within 28 days before the first dose. Inactivated (non-live) vaccines are generally permitted.
• People with a history of abusing psychoactive substances or recreational drugs.
• People who still have significant side effects from previous cancer treatments that have not recovered to a mild level (Grade 1 or lower), with some exceptions such as hair loss.
• People who have had another type of cancer within the past 3 years, unless it has been fully treated and cured. Some exceptions may apply for certain types of skin cancer, early-stage bladder cancer, some cervical, breast, and thyroid conditions that were treated locally (confirm with trial site).
• People with mycosis fungoides, Sézary syndrome, or primary cutaneous (skin-based) T-cell lymphoma.
• People whose lymphoma has spread to the brain or spinal cord, currently or in the past.
• People whose lymphoma has spread to the testicles or breast tissue, currently or in the past.
• People who have or have had a serious condition called hemophagocytic syndrome, where the immune system attacks the body's own blood cells.
• People who have or have had other blood or bone marrow conditions in addition to their lymphoma, such as immune thrombocytopenia, autoimmune haemolytic anaemia, or aplastic anaemia.
• People who have or have had a type of blood cancer called acute myeloid leukaemia (AML).
• People who have or have had T-cell lymphoblastic lymphoma or T-lymphoblastic leukaemia.
• People who have any history of myeloid blood cancers, including a condition called myelodysplastic syndrome (MDS), or who have abnormal test results related to MDS or related bone marrow conditions.
• People who have had significant neurological conditions in the past, including but not limited to epilepsy, stroke, paralysis, severe brain injury, Alzheimer's disease, Parkinson's disease, or certain mental health conditions.
• People with significant heart or cardiovascular disease.
• People whose tumour is growing into or pressing against important structures such as the heart, windpipe, food pipe (oesophagus), or major blood vessels, in a way that could cause serious bleeding or abnormal connections between organs (confirm with trial site).
• People with fluid build-up around the lungs, abdomen, or heart that has not been well controlled despite repeated treatment.
• People with unexplained fever above 38.0°C.
• People with a serious active infection anywhere in the body.
• People who have had a tuberculosis (TB) infection within the past year, or who had TB more than one year ago without receiving adequate treatment.
• People known to have HIV, AIDS, or who test positive for syphilis (anti-TP positive).
• People with active hepatitis B (detectable HBV-DNA) or active hepatitis C (detectable HCV-RNA).
• People who are unable to swallow tablets or capsules, or who have active gut inflammation, long-term diarrhoea, a known condition called diverticular disease, or who have had part or all of the stomach surgically removed or banded, in a way that may affect how the drug is absorbed. Acid reflux that has been treated with proton pump inhibitors may be acceptable if there is no risk of drug interaction (confirm with trial site).
• People with known bleeding disorders such as von Willebrand disease or haemophilia.
• People who are pregnant, breastfeeding, or who plan to become pregnant during the trial period.
• People who, for any other reason, may not be able to complete the trial, or who the supervising doctor does not consider suitable for participation.

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