NCT06552559 Selinexor With ICE Chemotherapy in Secondary Central Nervous System Involving B-cell Non-Hodgkin Lymphoma
| NCT ID | NCT06552559 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Samsung Medical Center |
| Condition | B-cell Lymphoma Recurrent |
| Study Type | INTERVENTIONAL |
| Enrollment | 37 participants |
| Start Date | 2024-05-01 |
| Primary Completion | 2028-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 37 participants in total. It began in 2024-05-01 with a primary completion date of 2028-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Seok Jin Kim
STUDY CHAIR
Samsung Medical Center
Frequently Asked Questions
Who can join the NCT06552559 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying B-cell Lymphoma Recurrent. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06552559 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06552559 currently recruiting?
Yes, NCT06552559 is actively recruiting participants. Contact the research team at kstwoh@skku.edu for enrollment information.
Where is the NCT06552559 trial being conducted?
This trial is being conducted at Seoul, South Korea, Seoul, South Korea.
Who is sponsoring the NCT06552559 clinical trial?
NCT06552559 is sponsored by Samsung Medical Center. The principal investigator is Seok Jin Kim at Samsung Medical Center. The trial plans to enroll 37 participants.