Phase 2 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 aged 18 or older
• People who have been diagnosed with mantle cell lymphoma (MCL), confirmed by a pathology test, including a specific protein marker called CD20
• People who have newly diagnosed MCL and have not yet received any treatment for it, and whose disease is classified as low or medium risk based on tumour size and certain biological features
• People with certain pre-existing but well-controlled heart or cardiovascular conditions, including those on some blood thinners (not warfarin or similar medications), blood pressure medications, or with prior heart procedures — a heart assessment may be required
• People who are willing and able to read and sign a consent form approved by an ethics review board
• People who have at least one area of measurable disease visible on scans, or disease present in the gut, bone marrow, or spleen only
• People whose general physical functioning is rated at a level of 2 or less on a standard medical scale (meaning they are able to care for themselves but may not be able to do heavy physical work)
• People whose blood clotting levels are within an acceptable range (those with certain known clotting conditions may still be eligible after discussion with the trial doctor)
• People with adequate bone marrow function, meaning blood cell counts meet minimum levels — those with low counts caused by significant MCL involvement in the bone marrow may still be considered after discussion with the trial team
• People with adequate kidney and liver function based on blood test results
• People with a life expectancy of more than 12 weeks related to their lymphoma
• Women who are either surgically unable to have children, have been through menopause for at least one year, or have had a negative pregnancy test within 7 days before starting treatment
• Women who could become pregnant, and men whose partners could become pregnant, who are willing to use a highly effective form of contraception during the trial and for a specified period after treatment ends (at least 1 month after the last dose of one study drug, and 12 months after the last dose of the other, whichever is longer)

Who may not be able to join:

• People whose MCL has spread to the brain or spinal fluid, or who have or are suspected to have a serious brain infection called progressive multifocal leukoencephalopathy (PML)
• People whose MCL is classified as high risk, based on features such as aggressive tumour cell appearance, very high tumour growth rate, large tumours, very high white blood cell counts, or certain genetic abnormalities
• People who have had major surgery within 4 weeks before joining the trial
• People with a history of abnormal or excessive bleeding disorders
• People with a currently active CMV (cytomegalovirus) infection
• People with other serious, uncontrolled infections or significant active medical conditions that the trial doctor believes could make participation unsafe
• People with serious heart conditions such as uncontrolled irregular heartbeat, heart failure, or a heart attack within the past 6 months, or certain abnormal heart rhythm readings on an ECG
• People with conditions that significantly affect the ability to absorb food or medication through the gut, including bowel obstruction or removal of parts of the digestive system
• People who are pregnant, planning to become pregnant during the trial or within the required period after treatment ends
• People who are breastfeeding during the trial or within a specified period after treatment
• People currently taking certain medications that strongly affect how the body processes drugs (a class called CYP3A4 inhibitors or inducers), or who consume grapefruit, Seville oranges, or star fruit
• People taking warfarin or similar blood-thinning medications (vitamin K antagonists)
• People who have difficulty swallowing tablets or capsules, or have gut conditions that would prevent proper absorption of oral medication
• People who have had a stroke or bleeding in the brain within the past 6 months
• People who have received a live vaccine within 28 days before joining the trial
• People with a known allergic reaction to the study drugs (pirtobrutinib or rituximab) or their ingredients
• People who previously experienced a major bleeding event or a serious irregular heartbeat (grade 3 or higher) while taking a type of drug called a BTK inhibitor
• People who have tested positive for HIV; those with unknown HIV status will be tested, and a negative result is required
• People with active hepatitis B or hepatitis C virus infection, based on specific blood test results (some cases may be reviewed by an infectious disease specialist before a decision is made)
• People with a prolonged heart rhythm interval (QTcF greater than 470 milliseconds) on an ECG taken during screening
• People who have or have had another cancer within the past year, with some exceptions such as certain treated skin cancers, treated cervical changes, some localised breast or prostate cancers that are well controlled — these cases are assessed individually (confirm with trial site)
• People with uncontrolled autoimmune conditions affecting blood cells, such as autoimmune haemolytic anaemia or immune thrombocytopenia, where new or increased treatment has been needed in the past 4 weeks
• People currently receiving other cancer treatments, immunotherapy, cell-based therapies, or radiation therapy at the same time
• People with a history of graft-versus-host disease or who have received an organ or stem cell transplant from another person
• People with other serious medical or psychiatric conditions that the trial doctor believes would make participation unsafe or affect trial results
• People with known allergies to certain medications used to manage uric acid levels (xanthine oxidase inhibitors or rasburicase)

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