drugset
drugset / Trial / NCT04607772

Study of Selinexor in Combination With Backbone Treatments or Novel Therapies In Participants With Relapsed or Refractory (RR) Diffuse Large B-Cell Lymphoma (DLBCL)

NCT04607772 ↗

Phase 1/2 Withdrawn Karyopharm Therapeutics Inc
Non-randomizedSequentialOpen-labelTreatment

Summary

This is a Phase 1/2, multicenter, open-label study to evaluate the efficacy, and safety of various combinations with selinexor in participants with RR DLBCL. The study will be conducted in two phases: Phase 1 and 2. The Phase 1 of the study will be a standard 3 + 3 dose escalation to determine the maximal tolerated dose (MTD), recommended Phase 2 dose (RP2D) for each treatment arm, and assess the dose limiting toxicities (DLTs). The Phase 2 of the study will be a dose expansion study to assess the efficacy and safety of for RP2D selected at the end of Phase 1 of the study for each treatment arm.

Timeline

Start
2020-11-18
Primary completion
2025-12
Completion
2025-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Bendamustine Small molecule 90 mg/m2 Intravenous
Subject Gemcitabine Small molecule 1000 mg/m2 Intravenous
Subject Ibrutinib Small molecule 420 mg Oral
Subject Ibrutinib Small molecule 560 mg Oral
Subject Lenalidomide Other / unclassified 20 mg Oral
Subject Lenalidomide Other / unclassified 25 mg Oral
Subject Oxaliplatin Small molecule 100 mg/m2 Intravenous
Subject Polatuzumab Vedotin Other / unclassified 1.8 mg/kg Intravenous
Subject Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Subject Selinexor Other / unclassified 40 mg Oral
Subject Selinexor Other / unclassified 60 mg Oral
Subject Selinexor Other / unclassified 80 mg Oral
Subject Tafasitamab Monoclonal antibody 12 mg/kg Intravenous
Subject Venetoclax Small molecule 200 mg Oral
Subject Venetoclax Small molecule 400 mg Oral
Subject Venetoclax Small molecule 600 mg Oral
Subject Venetoclax Small molecule 800 mg Oral

Indications

diffuse large B-cell lymphoma