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 aged 18 or older
• People who have been confirmed through a biopsy to have a type of lymphoma called mantle cell lymphoma that tests positive for a protein called CD20
• People who have not yet received any treatment for their lymphoma
• People whose lymphoma is at stage II, III, or IV (meaning it has spread beyond one area)
• People whose general health and ability to carry out daily activities meets a certain minimum level, and whose health has not declined significantly in the two weeks before joining the trial
• People under 65 must also meet all of the following additional conditions: their lymphoma risk score (called sMIPI) is low to intermediate; a measure of how fast the cancer cells are growing (called Ki67) is below 50%; there is no specific gene mutation called TP53 found by a detailed genetic test; the largest affected area is no bigger than 5 cm; and the lymphoma is not an aggressive subtype called blastoid or polymorphic
• People who have at least one area of lymphoma that can be measured and tracked during the trial
• People whose organs (such as kidneys, liver, and heart) and bone marrow are functioning adequately at the time of screening
• Women who are able to become pregnant must use contraception as required by local guidelines
• Men must agree not to donate sperm during the trial and for 12 months after receiving a treatment called rituximab
• People who are willing to attend all required appointments, complete all procedures, and are able to swallow capsules and tablets
• People who understand the purpose and risks of the trial and have signed a consent form agreeing to their health information being used

Who may not be able to join:

• People who have previously had treatment to reduce tumour size before a stem cell transplant
• People who have had lymphoma affecting the brain, spinal fluid, or spinal cord
• People with a serious or poorly controlled illness that the trial doctor believes could put them at risk or affect their ability to follow the trial plan — for example, uncontrolled high blood pressure or a history of kidney transplant
• People with a history of, or a current diagnosis of, a serious brain infection called progressive multifocal leukoencephalopathy (PML)
• People who have taken an experimental drug within 30 days (or within 5 half-lives of that drug, whichever is shorter) before starting this trial
• People who have had major surgery within 30 days before starting the trial, or who have not fully recovered from a recent surgery
• People with a history of another cancer, with some exceptions: certain skin cancers, cervical or prostate cancers that were fully treated at any point before the trial, or other cancers that were treated with surgery and/or radiation with no signs of disease for at least 3 years and no ongoing treatment
• People with serious heart problems, such as symptomatic irregular heartbeat, heart failure, or a heart attack within the past 6 months, or a significant level of heart disease identified during screening (note: people with well-controlled, symptom-free atrial fibrillation may still be eligible — confirm with trial site)
• People who have persistent nausea and vomiting, trouble swallowing, or a condition affecting how the body absorbs medications; or people who have had stomach bypass or weight-loss surgery, bowel blockage, or major bowel surgery that could affect how the trial drug is absorbed
• People who have received a live-virus vaccine within 28 days before starting the trial
• People known to be living with HIV
• People with any active significant infection, including bacterial, viral, or fungal infections, or a positive test for a virus called CMV
• People with signs of active hepatitis B or C infection based on blood tests
• People who have had a stroke or bleeding in the brain within 6 months before starting the trial
• People with a history of a bleeding disorder such as haemophilia or Von Willebrand disease
• People who need or are currently taking a blood-thinning medication called warfarin or a similar type of drug (called vitamin K antagonists)
• People who need to take certain medications that strongly affect how the body processes drugs (called strong CYP3A inhibitors or inducers), or who have taken these medications recently before starting the trial
• People who are pregnant or breastfeeding
• People who are currently taking part in another treatment clinical trial
• People who need to take a type of medication called a proton pump inhibitor (examples include omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole)
• People with a life-threatening illness or organ problem that the trial doctor believes could make participation unsafe

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