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:

• Adults aged 18 or older
• People who have given written consent before any study-related assessments take place
• People with a confirmed diagnosis of Mantle Cell Lymphoma (MCL) according to recognised 2022 classification systems, including the classical, small-cell, and marginal-zone types
• People who have never received treatment for MCL (a prior spleen removal for diagnosis does not disqualify someone)
• People who currently have no symptoms from their MCL
• People whose general physical fitness is rated at a good level (ECOG score of 0 or 1), meaning they are fully active or have only minor limitations in strenuous activity
• People at any disease stage (I through IV) with no symptoms caused by the MCL
• People whose MCL mainly involves the bone marrow or blood (leukemic non-nodal form), or those with low disease burden — meaning swollen lymph nodes no larger than 3 cm and a low tumour growth rate (Ki67 under 30%)
• People whose blood test results at screening meet specific thresholds for white blood cells, haemoglobin, platelets, liver enzymes, bilirubin, kidney function, and blood clotting (confirm exact values with the trial site)
• People whose disease has been stable with no signs of progression for at least 3 months, including those who have been under observation for longer than 3 months
• Women who could become pregnant must have a negative pregnancy test at screening and agree to use highly effective contraception during treatment and for at least 1 month after the last dose of pirtobrutinib, or 12 months after the last dose of rituximab
• Men who are sexually active with a woman who could become pregnant must agree to use highly effective contraception during treatment and for at least 1 month after the last dose of pirtobrutinib, or 12 months after the last dose of rituximab
• People who are willing and able to give signed informed consent and follow the study requirements
• People who have not participated in another clinical trial or received an experimental drug unrelated to MCL in the past 2 years

Who may not be able to join:

• People with the more aggressive forms of MCL known as blastoid or pleomorphic variants
• People with a condition called B-cell monoclonal lymphocytosis that looks like MCL but is not a confirmed MCL diagnosis
• People who have B symptoms (such as fever, night sweats, or significant weight loss) or any noticeable symptoms related to their MCL
• People with swollen lymph nodes larger than 3 cm at their widest point
• People whose MCL has caused organ problems, including kidney function below a certain level or significantly abnormal liver results
• People with a blood enzyme called LDH above the normal range
• People with known MCL involvement in the brain or spinal cord (central nervous system)
• People who are expected to need active MCL treatment within 3 months
• People who require blood-thinning medication using vitamin K antagonists (such as warfarin)
• People with a history of bleeding disorders
• People who have had a stroke or bleeding in the brain within the 6 months before joining
• People with significant heart problems, including recent unstable chest pain or heart attack, a weak heart pump, severe heart failure, or uncontrolled irregular heart rhythms
• People with a specific abnormal heart electrical reading (QTcF above 470 msec), unless a cause can be safely corrected (people with pacemakers may still be eligible if they have no history of fainting or relevant heart rhythm problems)
• People who test positive for HIV; people with unknown HIV status will be tested, and a negative result is required to join
• People with an active hepatitis B infection; those with certain hepatitis B markers may require additional testing before a decision is made, and some may need preventive antiviral treatment
• People who test positive for active hepatitis C infection
• People with a known active cytomegalovirus (CMV) infection
• People who have had another cancer in the past 2 years, other than certain skin cancers or early-stage cervical cancer
• People who have had major surgery within 4 weeks of joining
• People who have received a live or live-attenuated vaccine within 4 weeks of joining
• People with active, uncontrolled immune conditions affecting blood cells (such as autoimmune haemolytic anaemia or immune thrombocytopenic purpura) that required new or increased treatment within the 4 weeks before joining
• People with other serious uncontrolled conditions, such as active uncontrolled infections (bacterial, viral, fungal, or parasitic, excluding fungal nail infections), or any other significant active health issue that the trial doctor considers a risk
• People with a known allergy to pirtobrutinib, rituximab, or any of their ingredients
• Women who are pregnant, breastfeeding, or planning to become pregnant or begin breastfeeding during the study or within 1 month of the last dose of pirtobrutinib, or 12 months of the last dose of rituximab
• People who are unable to swallow tablets or who have conditions that significantly affect how the gut absorbs medication

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