Tafasitamab and Rituximab for Front-Line Treatment of Post-Transplant Lymphoproliferative Disorder
Phase II Study to Assess the Efficacy of Combined Tafasitamab and Rituximab in Front-Line Treatment of Post-Transplant Lymphoproliferative Disorder
Sponsor: Timothy Voorhees
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Rate of patients who achieve a complete response (CR)
Time frame: within 1 week after 4 cycles of combined therapy
Secondary Endpoints
Incidence of adverse events
Overall response rate
Best overall response
Eligibility Criteria
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 of \> 1.5 cm in diameter and/or bone marrow involvement * Subjects having undergone heart, lung, liver, kidney, pancreas, small intestine transplantation or a combination of the organ transplantations mentioned * No prior lines of therapy for PTLD (palliative radiation, steroids, antiviral therapy, and reduction in immunosuppression are allowed) * Human immunodeficiency virus (HIV) infection is all…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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