Selinexor With ICE Chemotherapy in Secondary Central Nervous System Involving B-cell Non-Hodgkin Lymphoma

Phase 1

Recruiting

• Conditions: B-cell Lymphoma Recurrent; B-cell Lymphoma Refractory; CNS Metastases
• Interventions: Drug: Selinexor

• Registration Number: NCT06552559
• Lead Sponsor: Samsung Medical Center

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 ...

Detailed Description

1. Background Secondary central nervous system (CNS) involvement, such as CNS relapse after treatment or progression involving the CNS 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 p...

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2024-05-01
• Status Verified: 2024-08
• Study First Submitted: 2024-08-03
• Study First Submitted QC: 2024-08-10
• Last Update Submitted: 2024-08-10
• Study First Posted: 2024-08-14
• Last Update Posted: 2024-08-14
• Primary Completion: 2026-12-30
• Study Completion: 2027-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 37

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

Read More

Exclusion Criteria

• Patients cannot fulfill the above-mentioned inclusion criteria
• Patients with primary CNS lymphoma
• Patients with a prior history with selinexor

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Selinexor plus ICED	Selinexor	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

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose of elinexor in phase 1	Up to 1 year	Maximum tolerated dose and recommended phase 2 dose level of Selinexor combined with ifosfamide, carboplatin, etoposide and dexamethasone
Objective response rate	Up to 2 years	Complete and partial response out of participants in phase 2

Secondary Outcome Measures

Name	Time	Method
Duration of response	Uo to 3 years	Time between the first determined response and the data of porgression

Trial Locations

Locations (2)

Samsung Cancer Research Institute; 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of