NCT04442022

A Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) With or Without Selinexor in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma

A Phase 2/3, Multicenter Randomized Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) With or Without Selinexor in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (RR DLBCL)

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 501 (estimated)
• Sponsor: Karyopharm Therapeutics Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this Phase 2/3 study is to evaluate efficacy and safety of the combination of selinexor and R-GDP (SR-GDP) in patients with RR DLBCL who are not intended to receive hematopoetic stem cell transplantation (HSCT) or chimeric antigen receptor T cell (CAR-T) therapy. This study consists of 3 arms each in Phase 2 and 3. Phase 2 portion of the study will assess the two doses of selinexor (40 milligram \[mg\] or 60 mg) in combination with R-GDP, for up to 6 cycles (21-day per cycle), followed by 60 mg selinexor single agent continuous therapy for those who have reached a partial or complete response. Phase 3 portion of the study will evaluate the selected dose of SR-GDP (identified in Phase 2) versus standard R-GDP + matching placebo, for up to 6 cycles (21-day per cycle), followed by placebo or 60 mg selinexor single agent continuous therapy for those who have reached partial or complete response.

Conditions

• Relapsed/Refractory Diffuse Large B-cell Lymphoma

Interventions

Type	Name	Description
DRUG	Selinexor (combination therapy)	Dose: 40 mg on Days 1 and 8 of each 21-day cycle for up to 6 cycles; Route of administration: oral
DRUG	Selinexor (combination therapy)	Dose: 60 mg on Days 1 and 8 of each 21-day cycle for up to 6 cycles; Route of administration: oral
DRUG	Selinexor (combination therapy)	Dose: Selected dose of selinexor (from Phase 2) on Days 1 and 8 of each 21-day cycle for up to 6 cycles; Route of administration: oral
DRUG	Placebo matching for Selinexor (combination therapy)	Dose: Placebo matching for selected dose of selinexor (from Phase 2) on Days 1 and 8 of each 21-day cycle for up to 6 cycles; Route of administration: oral
DRUG	Rituximab (combination therapy)	Dose: 375 milligram per meter square (mg/m\^2) on Day 1; Route of administration: intravenous (IV)
DRUG	Rituximab (combination therapy)	Dose: 375 mg/m\^2 on Day 1; Route of administration: IV
DRUG	Gemcitabine (combination therapy)	Dose: 1000 mg/m\^2 on Days 1 and 8; Route of administration: IV
DRUG	Dexamethasone (combination therapy)	Dose: 40 mg (20 mg if patient is more than 70 years old) on Days 1, 2, 3, and 4; Route of administration: oral or IV
DRUG	Cisplatin (combination therapy)	Dose: 75 mg/m\^2 on Day 1; Route of administration: IV
DRUG	Selinexor (continuous therapy)	Dose: 60 mg QW for each 28-day cycle until PD; Route of administration: oral
DRUG	Placebo matching for Selinexor (continuous therapy)	Dose: Placebo matching for 60 mg selinexor QW for each 28-day cycle until PD; Route of administration: oral

Timeline

• Start date: 2020-09-03
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2020-06-22
• Last updated: 2025-10-03

Locations

57 sites across 7 countries: United States, Austria, China, Israel, Italy, Poland, Spain

Regulatory

• FDA-regulated drug study