drugset
drugset / Trial / NCT06977711

Loncastuximab and Roflumilast Added to R-CHOP (Lo-(Rituximab and Roflumilast) RR-CHOP) for Naïve High-Risk Diffuse Large B-cell Lymphoma (DLBCL)

NCT06977711 ↗

Phase 1 Recruiting 10 enrolled The University of Texas Health Science Center at San Antonio
NaSingle-groupOpen-labelTreatment

Summary

This study is developed by the investigator and is a, phase I, single arm, clinical trial that will enroll subjects with untreated diffuse large B-cell lymphoma (DLCBL) at high risk for poor outcome. The types of treatments given will be shared with participants. The aims are: 1. To assess the safety and how well the participants tolerate the treatment 2. Assess the response of the tumor to treatment to estimate complete response 3. Assess the response of the tumor to treatment to estimate progression-free survival

Timeline

Start
2025-06-20
Primary completion
2026-10-15
Completion
2027-04-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Loncastuximab Monoclonal antibody 0.075 mg/kg Intravenous
Subject Roflumilast Small molecule 500 ug Oral
Background Cyclophosphamide Other / unclassified 750 mg/m2 Intravenous
Background Doxorubicin Other / unclassified 50 mg/m2 Intravenous
Background Prednisone Other / unclassified 100 mg Oral
Background Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Background Vincristine Small molecule 1.4 mg/m2 Intravenous

Indications

diffuse large B-cell lymphoma