Loncastuximab Tesirine and Rituximab as First-line Therapy in Patients With Post-transplant Lymphoproliferative Disorder (PLUTO)

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Utah

About this trial

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 criteria

Qualifiers

Subject aged ≥ 18 years.

Histologically confirmed B-cell PTLD (monomorphic and polymorphic) following solid organ transplantation; with or without EBV association.

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.

Disqualifiers

PTLD following liquid transplantation

CNS involvement

Prior treatment for PTLD with the exception of radiation, antivirals, steroids and reduced immunosuppression

Human immunodeficiency virus (HIV) infection

Trial design

Treatments tested in this trial

  • Loncastuximab tesirine
  • Rituximab or rituximab biosimilar

Treatment groups

23 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Sponsors and collaborators

University of Utah

Lead sponsor

ADC Therapeutics S.A.

Collaborator