A Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) With or Without Selinexor in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
← catalyst calendarNCT04442022 · readout ≤ 134 d
Sponsored by Karyopharm Therapeutics Inc (industry) · KPTI — their whole pipeline →.
Phase
Phase 2/3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
501estimated
Sites
38
Countries
China, Israel, Italy +3
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2020-09-03 | actual | When the study began enrolling |
| Primary completion | Dec 2026 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Dec 2026 | estimated | The whole study's end, after follow-up |
| First posted | 2020-06-22 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-02 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Relapsed/Refractory Diffuse Large B-cell Lymphoma
Interventions
- Drug: Selinexor (combination therapy)
- Drug: Selinexor (combination therapy)
- Drug: Selinexor (combination therapy)
- Drug: Placebo matching for Selinexor (combination therapy)
- Drug: Rituximab (combination therapy)
- Drug: Rituximab (combination therapy)
- Drug: Gemcitabine (combination therapy)
- Drug: Dexamethasone (combination therapy)
- Drug: Cisplatin (combination therapy)
- Drug: Selinexor (continuous therapy)
- Drug: Placebo matching for Selinexor (continuous therapy)
Primary outcomes
what the primary-completion date above is the date OFPhase 2: Overall Response Rate (ORR): Based on Lugano Criteria 2014
measured From date of initial randomization to the date of disease progression or initiating a new DLBCL treatment (maximum of 5 years from randomization)
Phase 3: Progression-free Survival (PFS): Based on Lugano Criteria 2014
measured From date of initial randomization to the date of disease progression or death (maximum of 5 years from randomization)
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