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).

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-513616-95-00

Acronym

XPORT-DLBCL-30

Enrollment

Registered

2024-11-07

Start date

2020-12-22

Completion date

Unknown

Last updated

2025-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsed/Refractory Diffuse Large B-Cell Lymphoma (RR DLBCL)

Brief summary

Phase 2: overall response rate (ORR) based on the Lugano Classification 2014., Phase 3: Progression-free survival (PFS) based on the Lugano Classification 2014

Detailed description

Phase 2: Progression-free survival (PFS) based on the Lugano Classification 2014. Overall survival, Phase 3: overall response rate (ORR) based on the Lugano Classification 2014. Overall survival.

Interventions

DRUGZarzio 48 MU/0.5 ml solution for injection or infusion in pre-filled syringe

DRUGSELINEXOR

DRUGOndansetron Aurobindo 8 mg Filmtabletten

DRUGDexametazona Krka 4 mg comprimate

DRUGCisplatin 1 mg/ml Concentrate for Solution for Infusion

DRUGCarboplatin Hikma 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGSelinexor placebo for 20 mg tablets is formulated for oral administration. Selinexor placebo tablets are film coated bi-convex round tablets

DRUGRixathon 500 mg concentrate for solution for infusion

DRUGEMEND 125 mg+80 mg hard capsules

DRUGGemcitabine 2 g Powder for Solution for Infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Phase 2: overall response rate (ORR) based on the Lugano Classification 2014., Phase 3: Progression-free survival (PFS) based on the Lugano Classification 2014	—

Secondary

Measure	Time frame
Phase 2: Progression-free survival (PFS) based on the Lugano Classification 2014. Overall survival, Phase 3: overall response rate (ORR) based on the Lugano Classification 2014. Overall survival.	—

Countries

Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026