This phase II trial tests how well tafasitamab and rituximab work for front-line treatment of patients with post-transplant lymphoproliferative disorder. Post-transplant lymphoproliferative disorder (PTLD) is the name for types of lymphoma that sometimes develop in people who have had a transplant. It can affect people who are taking medicines to suppress their immune system. Tafasitamab injection is in a class of medications called monoclonal antibodies. It works by helping the body to slow or stop the growth of cancer cells. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving the combination of tafasitamab and rituximab may work better in treating patients with post-transplant lymphoproliferative disorder.
Written informed consent obtained to participate in the study and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information
Age >= 18 years at the time of consent
Karnofsky scale > 30% or Eastern Cooperative Oncology Group (ECOG) =< 3 (can be assessed after pre-phase steroids)
Histological evidence of B-cell PTLD (monomorphic and polymorphic) following solid organ transplantation; expresses CD19 and CD20, with or without EBV association, confirmed after biopsy or resection of tumor
Uncontrolled active infection. Patients requiring systemic therapy are eligible if the infection is deemed controlled by the investigator
Post-transplant lymphoproliferative disorder following liquid transplantation
Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study and lactating females must agree to not breastfeed while taking study drugs)
Subjects with central nervous system (CNS) involvement by PTLD
Timothy Voorhees
Lead sponsor
Ohio State University Comprehensive Cancer Center
Sponsor institution