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)
About This Trial
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.
Who May Be Eligible (Plain English)
Original Eligibility Criteria
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Treatments Being Tested
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
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
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
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
Rituximab (combination therapy)
Dose: 375 milligram per meter square (mg/m\^2) on Day 1; Route of administration: intravenous (IV)
Rituximab (combination therapy)
Dose: 375 mg/m\^2 on Day 1; Route of administration: IV
Gemcitabine (combination therapy)
Dose: 1000 mg/m\^2 on Days 1 and 8; Route of administration: IV
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
Cisplatin (combination therapy)
Dose: 75 mg/m\^2 on Day 1; Route of administration: IV
Selinexor (continuous therapy)
Dose: 60 mg QW for each 28-day cycle until PD; Route of administration: oral
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