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A Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) With or Without Selinexor in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
MinorEligibility criteria expanded, about 45 wordsStudy sites revised (38)Show 1 more changeShow less
Study sites revised (38)
MinorRe-verified, no change to tracked fieldsv26
NotablePrimary and study completion dates: Dec 2025 to Dec 2026Trial status: Recruiting to Active, Not Recruiting · Study sites: 57 to 38v25Show 2 more changesShow less
Trial status: Recruiting to Active, Not Recruiting
Study sites: 57 to 38
MinorSite details revised at 21 of 57 sitesv24
NotablePrimary completion date: Dec 2024 to Dec 2025Site details revised at 1 of 57 sitesv23Show 1 more changeShow less
NotablePrimary completion date: Aug 2025 to Aug 2023Study sites: 62 to 58 · Completion date: Aug 2027 to Aug 2024v5Show 2 more changesShow less
Study sites: 62 to 58
Completion date: Aug 2027 to Aug 2024
NotableTrial status: Not Yet Recruiting to RecruitingEnrollment target: 492 to 501 · Study sites: 53 to 62 · Start date changed from estimate of Sep 30, 2020 to Sep 3, 2020 · 3 morev4Show 6 more changesShow less
Enrollment target: 492 to 501
Study sites: 53 to 62
Start date changed from estimate of Sep 30, 2020 to Sep 3, 2020
NotableStart date: Jun 2020 to Aug 1, 2020Study sites: 0 to 53v2Show 1 more changeShow less
Study sites: 0 to 53
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.