Using Selinexor with ICE chemotherapy for B-cell lymphoma with CNS involvement
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
This study is testing if adding Selinexor to standard chemotherapy can help people with B-cell lymphoma that has spread to the brain feel better when other treatments haven't worked.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 37 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Samsung Medical Center Academic / other |
| Drugs / interventions | chemotherapy, methotrexate |
| Locations | 2 sites (Seoul and 1 other locations) |
| Trial ID | NCT06552559 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the combination of Selinexor, a selective inhibitor of nuclear export, with ICE chemotherapy in patients suffering from B-cell non-Hodgkin lymphoma that has spread to the central nervous system. The study aims to evaluate the safety and efficacy of this treatment approach, particularly in cases where traditional therapies have failed. Participants will receive Selinexor alongside ifosfamide, carboplatin, etoposide, and dexamethasone, with the goal of improving response rates in a population that typically faces poor outcomes. The trial is designed for patients with measurable disease and specific eligibility criteria to ensure a focused assessment of the treatment's impact.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed B-cell non-Hodgkin lymphoma and measurable CNS involvement.
Not a fit: Patients who have not received prior anthracycline-based chemotherapy or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with B-cell lymphoma that has metastasized to the CNS, potentially improving survival rates.
How similar studies have performed: While there is limited data on the specific combination of Selinexor with ICE chemotherapy, other studies have shown promise in using Selinexor for relapsed or refractory B-cell lymphoma.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul and 1 other locations
- Samsung Cancer Research Institute — Seoul, South Korea (Recruiting)
- Samsung Medical Center — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Seok Jin Kim, MD., PhD
- Email: kstwoh@skku.edu
- Phone: 82234101766
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.