NCT05422066

Selinexor Plus R-CHOP in High-risk GCB-subtype Diffuse Large B-Cell Lymphoma

Recruiting now Phase 2 Last updated 17 June 2024

What this trial tests

Phase 2 trial testing Selinexor in DLBCL Germinal Center B-Cell Type in 50 participants. Currently enrolling.

Timeline

26 July 2022

Primary endpoint
30 July 2025

31 December 2025

Quick facts

Lead sponsor	Li Zhiming
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	26 July 2022
Primary completion	30 July 2025
Estimated completion	31 December 2025
Sites	6 locations across China

Drugs / interventions tested

• Selinexor
• Rituximab — full drug profile →
• Cyclophosphamide (cyclophosphamide) — full drug profile →
• Doxorubicin
• Vincristine (vincristine) — full drug profile →
• Prednisone (prednisone) — full drug profile →

Conditions studied

• DLBCL Germinal Center B-Cell Type — all drugs for DLBCL Germinal Center B-Cell Type →

Sponsor

Li Zhiming — full company profile →

Who can join

Adults 18 to 75, any sex, with DLBCL Germinal Center B-Cell Type. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a phase II, multicenter, single-arm and open-label study to explore Selinexor in combination with standard of care R-CHOP in New Diagnosed high-risk GCB-subtype DLBCL (IPI 3-5). Approximately 35 patients plan to be enrolled in about 6-8 study sites of the study. And the objective is to Evaluate the safety and efficacy of XR-CHOP in High-Risk (IPI 3-5) GCB-subtype DLBCL.The enrollment period for this study is expected to be approximately 18 months. The study will end when all patients have completed 6 cycles treatment/follow-up since the initiation of the study drug, or the last patient has expired, has been lost to follow-up, or has withdrawn consent, whichever occurs first.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. The progress of novel strategies on immune-based therapy in relapsed or refractory diffuse large B-cell lymphoma.
   Lu T, Zhang J, Xu-Monette ZY, Young KH. · · 2023 · cited 19× · PMID 37580826 · DOI 10.1186/s40164-023-00432-z
2. The Role of RNA-Binding Proteins in Hematological Malignancies.
   Aguilar-Garrido P, Otero-Sobrino Á, Navarro-Aguadero MÁ, Velasco-Estévez M, et al · · 2022 · cited 13× · PMID 36076951 · DOI 10.3390/ijms23179552
3. Novel-and Not So Novel-Inhibitors of the Multifunctional CRM1 Protein.
   Aumann WK, Kazi R, Harrington AM, Wechsler DS. · · 2024 · cited 3× · PMID 39161560 · DOI 10.3389/or.2024.1427497
4. Modulation of anti-tumour immunity by XPO1 inhibitors.
   Fisher JG, Bartlett LG, Kashyap T, Walker CJ, et al · · 2025 · cited 2× · PMID 40291981 · DOI 10.37349/etat.2025.1002310
5. Prognostic and functional role of the nuclear export receptor 1 (XPO1) in gastrointestinal cancers: a potential novel target?
   Sokolova V, Gruber R, Pammer LM, Kocher F, et al · · 2024 · cited 1× · PMID 39729162 · DOI 10.1007/s11033-024-10169-5
6. Metabolic vulnerabilities and therapeutic opportunities in diffuse large B-cell lymphoma.
   Neumann MA, Frezza C. · · 2026 · PMID 42140916 · DOI 10.1038/s41389-026-00629-x