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NCT06552559: SIENA
Selinexor With ICE Chemotherapy in Secondary Central Nervous System Involving B-cell Non-Hodgkin Lymphoma
Phase 1, PHASE2 trial testing Selinexor in B-cell Lymphoma Recurrent in 37 participants. Currently enrolling.
30 December 2026
Quick facts
| Lead sponsor | Samsung Medical Center |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 37 |
| Start date | 1 May 2024 |
| Primary completion | 30 December 2026 |
| Estimated completion | 30 December 2027 |
| Sites | 2 locations across South Korea |
Drugs / interventions tested
- Selinexor — full drug profile →
Conditions studied
- B-cell Lymphoma Recurrent — all drugs for B-cell Lymphoma Recurrent →
- B-cell Lymphoma Refractory — all drugs for B-cell Lymphoma Refractory →
- CNS Metastases — all drugs for CNS Metastases →
Sponsor
Samsung Medical Center
Who can join
18 and older, any sex, with B-cell Lymphoma Recurrent or B-cell Lymphoma Refractory. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Secondary involvement of the central nervous system (CNS), such as CNS relapse after treatment or progression during treatment, is a rare but deadly occurrence in patients with B-cell non-Hodgkin lymphoma (NHL), particularly in cases of diffuse large B-cell lymphoma (DLBCL) and transformed follicular lymphoma (FL). Despite the grim prognosis associated with secondary CNS involvement, no definitive treatment strategy exists. Selinexor®, an oral, first-in-class, potent selective inhibitor of nuclear export that binds to XPO1, leads to the nuclear retention of tumor suppressor and growth regulator proteins, as well as topoisomerase II enzymes, thereby restoring their functions. Preclinical studies have also shown that selinexor can sensitize cancer cells to topoisomerase inhibitors, alkylating agents, and steroids. Selinexor has been approved by the Food and Drug Administration for relapsed or refractory DLBCL. We hypothesize that selinexor could work synergistically with ifosfamide (an alkylating agent) and etoposide (a topoisomerase II inhibitor) in the ifosfamide, carboplatin, and etoposide (ICE) regimen. High-dose dexamethasone was added to this regimen to enhance the efficacy of ICE as a salvage regimen for secondary CNS involvement, due to its ability to cross the blood-brain barrier. This phase I/II study aims to evaluate the efficacy and safety of selinexor in combination with ifosfamide, carboplatin, etoposide (ICE), and dexamethasone in patients with relapsed or refractory B-cell non-Hodgkin lymphoma with secondary CNS involvement.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06552559
- Europe PMC full search
- ASCO Meeting Library
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Related trials
Other trials of Selinexor
Trials testing the same drug.
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- NCT07204041 — Efficacy and Safety of XTD Regimen (Selinexor, Thalidomide and Dexamethasone) in Adult Patients With Relapsed/Refractory · Phase 2 · active not recruiting
- NCT06966154 — A Phase Ib/II Clinical Study Evaluating the Safety and Efficacy of Tislelizumab in Combination With Golidocitinib and Se · Phase 1, PHASE2 · recruiting
- NCT06900088 — Selinexor Combined With Azacitidine Therapy in High-Risk Myeloid Neoplasms Patients · Phase 2 · not yet recruiting
Other recruiting trials for B-cell Lymphoma Recurrent
Currently open trials in the same condition.
- NCT05705570 — Clinical Trial Using CAR- T Cells for Treatment of Patients With Refractory or Relapsed CD19-positive B Lymphoid Maligna · Phase 1 · recruiting
- NCT04214886 — CD19 Chimeric Antigen Receptor (CAR) T Cells for Adults With Recurrent or Refractory B Cell Malignancies · Phase 1 · active not recruiting
Other Samsung Medical Center trials
Trials by the same sponsor.
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- NCT07500701 — Salvage Moderate Hypofractionated Versus Ultrahypofractionated Radiotherapy for Biochemical Recurrence After Radical Pro · Phase 3 · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06552559 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Samsung Medical Center
- Last refreshed: 14 August 2024
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