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
Single group
Biopsy
Procedure/SurgeryUndergo biopsy
Biospecimen Collection
Procedure/SurgeryUndergo collection of blood samples
Computed Tomography
Procedure/SurgeryUndergo CT
Positron Emission Tomography
Procedure/SurgeryUndergo PET
Rituximab
Biological/VaccineGiven IV or SC
Tafasitamab
Biological/VaccineGiven IV
Rate of patients who achieve a complete response (CR)
Assessed using Lugano criteria. Will be calculated as the number of patients who achieve CR divided by the number of evaluable patients, and presented with the 95% binomial confidence interval.
Incidence of adverse events
Adverse events will be described and classified per the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 guidelines. The maximum grade of each type of toxicity will be extracted for each patient, and frequency counts will be tabulated to determine toxicity patterns, especially for grade 3 or above adverse events.
Overall response rate
Defined as clinical response (CR + partial response \[PR\]) after 4 cycles of weekly (or 7-day) treatments with combined rituximab and tafasitamab using Lugano criteria.
Best overall response
Defined as best clinical response (CR + PR) at the completion of either 4 cycles of weekly (or 7-day) treatments or 4 consolidation cycles (every 3 week) of combined rituximab and tafasitamab using Lugano criteria. Will be estimated and 95% confidence interval computed.
Rate of CR after completion of consolidation treatments
Will be estimated and 95% confidence interval computed.
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Timothy Voorhees
Lead sponsor
Ohio State University Comprehensive Cancer Center
Sponsor institution
