Phase 2/3Active, not recruiting
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)
- Sponsor
- Karyopharm Therapeutics Inc (Industry)
- Enrolment
- 501 planned
- Conditions
- Relapsed/Refractory Diffuse Large B-cell Lymphoma
- Interventions
- Selinexor (combination therapy); Selinexor (combination therapy); Selinexor (combination therapy); Placebo matching for Selinexor (combination therapy); Rituximab (combination therapy); Rituximab (combination therapy); Gemcitabine (combination therapy); Dexamethasone (combination therapy); Cisplatin (combination therapy); Selinexor (continuous therapy); Placebo matching for Selinexor (continuous therapy)
- Ages
- adults, older adults
- Registry
- NCT04442022, EUCTR2020-000605-84
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Phase 2: Overall Response Rate (ORR): Based on Lugano Criteria 2014
- Phase 3: Progression-free Survival (PFS): Based on Lugano Criteria 2014
History
Primary completion expected
Last registry update
Started
Registered