Phase II Study to Assess the Efficacy of Combined Tafasitamab and Rituximab in Front-Line Treatment of Post-Transplant Lymphoproliferative Disorder
Timothy Voorhees
Summary
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.
Description
PRIMARY OBJECTIVE: I. To estimate the rate of complete response (CR) after 4 cycles of weekly (or 7-day) treatments with combined rituximab and tafasitamab in subjects with post-transplant lymphoproliferative disorder (PTLD). SECONDARY OBJECTIVES: I. To describe the safety profile of treatment with combined rituximab and tafasitamab in subjects with PTLD. II. To estimate the objective response rate (ORR), defined as clinical response (CR + partial response \[PR\]) after 4 cycles of weekly (or 7-day) treatments with combined rituximab and tafasitamab in subjects with PTLD. III. To determin…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 * Measurable disease o…
Interventions
- ProcedureBiopsy
Undergo biopsy
- ProcedureBiospecimen Collection
Undergo collection of blood samples
- ProcedureComputed Tomography
Undergo CT
- ProcedurePositron Emission Tomography
Undergo PET
- BiologicalRituximab
Given IV or SC
- BiologicalTafasitamab
Given IV
Locations (4)
- Rutgers Cancer Institute of New JerseyNew Brunswick, New Jersey
- University of North Carolina-Hillsborough CampusHillsborough, North Carolina
- Ohio State University Comprehensive Cancer CenterColumbus, Ohio
- Huntsman Cancer InstituteSalt Lake City, Utah