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)

A Multicenter, Phase 1/2 Study of Selinexor in Combination With Backbone Treatments or Novel Therapies in Patients With Relapsed or Refractory (RR) Diffuse Large B-Cell Lymphoma (DLBCL)

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Karyopharm Therapeutics Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Selinexor	Dose: 40 mg (2 tablets of 20 mg), 60 mg (3 tablets of 20 mg), 80 mg (4 tablets of 20 mg)
DRUG	Rituximab	Dose: 375 mg/m\^2
DRUG	Bendamustine	Dose: 90 mg/m\^2
DRUG	Polatuzumab Vedotin	Dose: 1.8 mg/kg
DRUG	Ibrutinib	Dose: 420, 560 mg
DRUG	Lenalidomide	Dose: 20, 25 mg
DRUG	Tafasitamab	Dose: 12 mg/kg
DRUG	Venetoclax	Dose: 200, 400, 600, 800 mg
DRUG	Gemcitabine	Dose: 1000 mg/m\^2
DRUG	Oxaliplatin	Dose: 100 mg/m\^2

Timeline

• Start date: 2020-11-18
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2020-10-29
• Last updated: 2025-10-03

Locations

18 sites across 1 country: United States

Regulatory

• FDA-regulated drug study