Clinical trial · Interventional
Selinexor With ICE Chemotherapy in Secondary Central Nervous System Involving B-cell Non-Hodgkin Lymphoma
Phase 1/2 Study of Selinexor With Dexamethasone, Ifosfamide, Carboplatin, and Etoposide in Patients Who Have Secondary Central Nervous System Involvement With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B-cell Lymphoma Recurrent | — | UNRESOLVED | — |
| B-cell Lymphoma Refractory | — | UNRESOLVED | — |
| CNS Metastases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Selinexor | Drug | Selinexor | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Selinexor plus ICED
- description
- Phase 1 part of the study: Treatment will be repeated every three weeks. * Selinexor: DL1 (40mg)/DL2 (60mg)/DL3 (80mg) PO, day 3, 5, 7 * Ifosfamide 1500 mg/m(2) infused over 2 h on days 1-3 * Carboplatin (5 AUC) on day 1 * Etoposide 100 mg/m(2) on days 1-3 * Dexamethasome 40 mg PO or IV on days 1-4 Phase 2 part of the study: Treatment will be repeated every three weeks. * Selinexor: MTD (determined by phase 1 part of the study) PO, day 3, 5, 7 * Ifosfamide 1500 mg/m(2) infused over 2 h on days 1-3 * Carboplatin (5 AUC) on day 1 * Etoposide 100 mg/m(2) on days 1-3 * Dexamethasome 40 mg PO or IV on days 1-4
- interventionNames
- Drug: Selinexor
Primary outcomes (2)
- measure
- Maximum tolerated dose of elinexor in phase 1
- timeFrame
- Up to 1 year
- description
- Maximum tolerated dose and recommended phase 2 dose level of Selinexor combined with ifosfamide, carboplatin, etoposide and dexamethasone
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have histologically confirmed B-cell NHL with CNS involvement DLBCL including ABC, GCB or PMBCL subtypes Indolent lymphomas transformed to aggressive lymphomas Follicular lymphomas * Patients must have received at least one cycles of anthracycline based chemotherapy administered with curative intent * Patients must be age ≥18 years. * Patients must have at least one site of measurable disease, 1.5 cm in diameter or greater. * Patients must have ECOG performance status of 0-2. * Patients must have laboratory test results within these ranges: Absolute neutrophil count ≥ 1500/mm³, Platelet count ≥ 100,000/mm³, Serum creatinine clearance ≥40 mL/min, Total bilirubin ≤ 1.5x ULN (Higher levels are acceptable if these can be attributed to active hemolysis or ineffective erythropoiesis.), AST (SGOT) and ALT (SGPT) ≤ 2x ULN * Women of childbearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test prior to selinexor treatment. Male patients must use an effective barrier method of contraception if sexually active with a female of child-bearing potential. * Patients must be able to understand and willing to sign a written informed consent document. * Patients must be able to adhere to the study visit schedule and other protocol requirements. * Patients must not have any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. * Patients must not have any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study. * Patients with hepatitis B virus including HBsAg-positive carrier or IgG anti- HBc-positive can be enrolled if they can receive anti-viral prophylaxis Exclusion Criteria: * Patients cannot fulfill the above-mentioned inclusion criteria * Patients with primary CNS lymphoma * Patients with a prior history with selinexor
References
Publications (0)
Data not yet available