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).
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.
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
Sequential
Loncastuximab tesirine
DrugLonca will be administered by IV at 75µg/kg every 3 weeks (DL1).
Rituximab or rituximab biosimilar
DrugRituximab 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)
6
Treatment groupsSee each treatment group below.
Phase I: Define Maximum Tolerated Dose (MTD) based on the rate of dose-limiting toxicities (DLTs) during the DLT evaluation period.
To assess the Recommended Phase 2 Dose (RP2D) of loncastuximab tesirine and rituximab in participants with post-transplant lymphoproliferative disorders (PTLD).
Phase II: The complete response (CR) rate after 4 cycles of lonca-R per Lugano 2014 criteria1.
To assess the efficacy of the combination of lonca-R based on CR rate after 4 cycles.
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type, severity (as defined by the NIH CTCAE, version 6.0), seriousness, duration, and relationship to study treatment.
To assess the safety and tolerability of lonca-R in subjects with B-cell PTLD.
The overall response rate (ORR) after 4 cycles of lonca-R.
To determine ORR after 4 cycles of lonca-R in subjects with B-cell PTLD.
The best complete response (CR) rate is defined as CR at the completion of 4 cycles of lonca-R or 4 cycles of lonca-R and 4 cycles of consolidation of rituximab monotherapy (every 3 weeks) in subjects with B-cell PTLD.
To determine the best CR rate in subjects with B-cell PTLD.
Median and two year progression-free survival (PFS). PFS will be as defined as the time from study drug initiation to the time of documented disease progression (as assessed by Lugano Criteria), or death from any cause.
To assess PFS.
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University of Utah
Lead sponsor
ADC Therapeutics S.A.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
