The University of Virginia is conducting a clinical research study for adults ages 18 and over who have mantle cell lymphoma. The purpose of this study is to test the efficacy and safety of an investigational treatment called pirtobrutinib. Pirtobrutinib is an investigational drug that may treat certain cancers like leukemia and lymphomas, including the type of cancer you were diagnosed with, mantle cell lymphoma (MCL). These cancers are dependent on or “addicted to” a protein called “BTK”. Pirtobrutinib is a “BTK inhibitor” – it is designed to block both normal and mutated forms of BTK in these cancers. Other drugs used to treat this type of cancer are ibrutinib, acalabrutinib, and zanubrutinib which are approved by the US FDA after chemotherapy. Pirtobrutinib is approved by the US FDA for adult patients after treatment with ibrutinib, acalabrutinib, and zanubrutinib. If you choose to take part in this study, you will receive either pirtobrutinib (Arm A) or your study doctor’s choice of either ibrutinib, acalabrutinib, or zanubrutinib (Arm B). This study will determine how long any benefits from treatment with pirtobrutinib (Arm A) lasts compared to you doctor’s choice of ibrutinib, acalabrutinib, or zanubrutinib (Arm B) and how well patients with MCL respond to treatment with pirtobrutinib.
The length of time that you remain on the study will depend on how long you continue on study drug and follow-up visits. Your participation in the study during the follow up period after the last dose of study drug can last up to 48 months.
Study-related procedures that are being done beyond your standard of care will be provided at no cost to you or your insurance.
Additional information can be found here: https://clinicaltrials.gov/ct2/show/NCT04662255
The study team may arrange for your hotel, or you may be reimbursed by check up to $175 per night for a hotel. You may also receive up to $.54 cents per mile.