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NCT04442022 · ClinicalTrials.gov record · last posted 2026-07-02

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

StatusActive, Not Recruiting
PhasePhase 2/3
Started2020-09-03
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from the ClinicalTrials.gov record
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.

Amendment record 25 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 25 times since 2020-06-18; most recent amendment 2026-06-30. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2026-05-05
Status change Recruiting→Active, Not Recruitingv24
2020-10-14
Status change Not Yet Recruiting→Recruitingv3
Trial Details
NCT Number NCT04442022
Lead Sponsor Karyopharm Therapeutics Inc
Conditions Relapsed/Refractory Diffuse Large B-cell Lymphoma
Enrollment 501 participants
Start Date 2020-09-03
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-07-02