A Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) With or Without Selinexor in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
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.
Timeline
- Start
- 2020-09-03
- Primary completion
- 2026-12
- Completion
- 2026-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Selinexor | Other / unclassified | 40 mg | Oral |
| Subject | Selinexor | Other / unclassified | 60 mg | Oral |
| Background | Cisplatin | Other / unclassified | 75 mg/m2 | Intravenous |
| Background | Dexamethasone | Small molecule | 20 mg | Oral |
| Background | Dexamethasone | Small molecule | 40 mg | Oral |
| Background | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Background | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |