University of Virginia
The purpose of this study is to study how avatrombopag (the study drug) may prevent certain side effects in adults with lymphoma and myeloma getting cancer treatment (CAR-T cell therapy). CAR (Chimeric Antigen Receptor) -T cell therapy is a common way to treat lymphoma and myeloma. However, during this kind of cell therapy a patient is at risk of developing lower-than-normal blood cell counts, including: * Red Blood Cells - important for many functions such as moving oxygen from the lungs to the body and moving carbon dioxide (CO2) back to the lungs * White Blood Cells - help fight against infection(s) * Platelets - help stop bleeding by forming clots when there is an injury When a person's platelet counts are lower than normal, this is called "thrombocytopenia". If you have thrombocytopenia, your body has a harder time stopping a bleed when there is an injury to a blood vessel. Thrombocytopenia over time may require additional treatments such as blood transfusions (getting extra platelets). Avatrombopag is a drug that has been shown to increase platelet numbers in people with other kinds of conditions. This study is trying to find out if taking avatrombopag both before and after CAR-T cell therapy will prevent platelet counts from getting too low. This is a research study to see if taking avatrombopag (in the form of pills) before, during, and after CAR-T cell therapy will reduce the chance of having thrombocytopenia as a side effect. This study is for people who are at high risk of thrombocytopenia after CAR T-Cell Therapy.
This is a phase II, single center, open-label trial that evaluates the use of a commercially available oral prophylactic thrombopoietin-receptor agonist (avatrombopag \[Doptelet\]) to reduce thrombocytopenia and improve recovery and outcomes post-CAR T-cell therapy in adult patients with lymphoma and myeloma who are at high risk of thrombocytopenia post CAR T-Cell Therapy. Avatrombopag is to be administered orally, 10 days prior to standard of care CAR T-Cell Infusion, at a starting dose of 20 mg (1 tablet), once daily, with food, in accordance with the package insert, with the exceptions to…
Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged ≥ 18 years old 4. ECOG performance status ≤ 2 5. Planned to receive FDA approved CAR T-cell therapy for large B-cell lymphoma, follicular lymphoma, mantle-cell lymphoma, chronic lymphocytic lymphoma, or multiple myeloma including (but not limited to): idecabtagene vicleucel, lisocabtagene maraleucel, ciltacabtagene autoleucel, tisagenlecleucel, brexucabtagene autoleucel, or axicabtagene cilol…
Avatrombopag (Doptelet) - immediate-release tablet, 20 mg