Lymphoma Trial, Recruiting

Written by an AI model from the 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 mantle cell lymphoma (MCL) confirmed by a laboratory test (pathology report)
• People aged between 18 and 80 years old, of any gender
• People who have not yet received any treatment for their MCL
• People who have at least one tumour that can be measured on a scan (at least 1.5 cm in size, or a measurable lesion on the spleen)
• People whose MCL has at least one of the following higher-risk features: intermediate-to-high risk score on a tool called the MIPI scale; a tumour cell growth rate (Ki-67) of 30% or higher; a specific aggressive cell appearance (blastoid or pleomorphic type); certain abnormalities in a gene called TP53 or related protein; a tumour measuring 7.5 cm or more at its widest point; or a complex pattern of chromosomal changes in the cancer cells (confirm with trial site)
• People who are reasonably well and able to carry out daily activities, as rated on a standard medical scale (ECOG score of 0, 1, or 2)
• People whose blood cell counts meet minimum levels, with no recent use of medications to boost those counts in the 7 days before testing
• People whose liver is functioning within acceptable ranges based on blood tests
• People whose kidneys are functioning within acceptable ranges based on blood tests
• People whose blood clotting test results are within acceptable ranges
• People who are expected to live for more than 3 months
• People who are able to give written consent and understand what taking part in the study involves
• People who are able to attend scheduled study visits and follow the study requirements

Who may not be able to join:

• People who have MCL that has spread to the brain or spinal cord, or who are suspected of having this, or who have had this in the past
• People who have previously received any systemic (whole-body) treatment for MCL, including a type of drug known as BTK inhibitors
• People who have an active, uncontrolled infection (fungal, bacterial, or viral) that has not responded to appropriate treatment
• People who have HIV, or who have active hepatitis B or C virus infection based on blood test results (specific hepatitis B and C antibody and PCR test results apply — confirm with trial site)
• People who have had a heart attack in the 6 months before joining the study
• People who have had unstable chest pain (unstable angina) in the 3 months before joining the study
• People who have a clinically significant irregular heartbeat or heart rhythm problem
• People whose heart rhythm measurement (QTcF interval) is above a specific threshold on an ECG
• People who have a history of certain types of heart conduction block (second-degree type II or third-degree AV block)
• People who have moderate-to-severe heart failure (NYHA class III or IV)
• People who have a history of serious bleeding disorders, such as haemophilia A, haemophilia B, or von Willebrand disease, or who have had spontaneous bleeding requiring a blood transfusion or medical treatment
• People who have had a blood clot in a deep vein (DVT) or in the lungs (pulmonary embolism) within the past 12 months
• People who have had a stroke or bleeding in the brain within the 6 months before starting the study drug
• People who are unable to swallow capsules, or who have significant gut or digestive problems such as malabsorption, bowel surgery, inflammatory bowel disease, or intestinal blockage
• People who are currently taking, or recently took, certain medications that strongly affect how the study drug is processed by the body (specific drugs called strong or moderate CYP3A inhibitors or inducers — confirm with trial site)
• People who are taking blood-thinning medication (anticoagulants) such as warfarin or similar drugs around the time of starting the study drug
• People who are pregnant or breastfeeding
• People who have a known allergy or sensitivity to any of the study drugs
• People who have a mental health condition or cognitive difficulty that would prevent them from understanding or following the study requirements
• People with a history of drug abuse or alcohol dependence

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