A Phase 1/2 Study of Loncastuximab Tesirine and Rituximab as First-line Therapy in Patients With Post-transplant Lymphoproliferative Disorder (PLUTO)
University of Utah
Summary
The purpose of phase I of this clinical trial is to learn the recommended dose of the drugs loncastuximab tesirine and rituximab in participants with post-transplant lymphoproliferative disorders (PTLD). The purpose of phase II of this clinical trial is to learn if the drugs loncastuximab tesirine and rituximab are effective in participants with post-transplant lymphoproliferative disorders (PTLD).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Subject aged ≥ 18 years. * Histologically confirmed B-cell PTLD (monomorphic and polymorphic) following solid organ transplantation; with or without EBV association. --Note: Subjects with classic Hodgkin-like PTLD are excluded. * Measurable disease as defined by the 2014 Lugano Classification as assessed by positron-emission tomography (PET)- computed tomography (CT) or by CT or magnetic resonance imaging (MRI) if the tumor is not fluorodeoxyglucose (FDG)-avid on screening * ECOG Performance Status ≤ 2. * Adequate organ function as defined as: * Hematologic: *…
Interventions
- DrugLoncastuximab tesirine
Lonca will be administered by IV at 75µg/kg every 3 weeks (DL1).
- DrugRituximab or rituximab biosimilar
Rituximab or rituximab biosimilar will be administered by IV at 375 mg/m2 on Day 1 of every cycle. Lonca will be administered first, followed by rituximab (with a 30 min wait time between the two agents)
Location
- Huntsman Cancer Institute at University of UtahSalt Lake City, Utah