Using Selinexor with ICE chemotherapy for B-cell lymphoma with CNS involvement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.