Actively Recruiting
Phase 1/2 Study of Selinexor With Dexamethasone, Ifosfamide, Carboplatin, and Etoposide in Patients With Secondary CNS Involvement of Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
Led by Samsung Medical Center · Updated on 2026-04-23
37
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Samsung Medical Center
Lead Sponsor
K
Korean Society of Hematology
Collaborating Sponsor
AI-Summary
What this Trial Is About
Secondary central nervous system (CNS) involvement in patients with B-cell non-Hodgkin lymphoma, especially diffuse large B-cell lymphoma (DLBCL) and transformed follicular lymphoma (FL), is a rare but serious condition with limited treatment options. This phase I/II trial investigates the safety and effectiveness of selinexor, an oral drug that restores tumor suppressor functions, combined with ifosfamide, carboplatin, etoposide (ICE regimen), and dexamethasone for patients with relapsed or refractory B-cell NHL involving the CNS. The study aims to improve outcomes where current salvage therapies have limited success.
CONDITIONS
Brief Title
Selinexor With ICE Chemotherapy in Secondary Central Nervous System Involving B-cell Non-Hodgkin Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed B-cell NHL with CNS involvement, including DLBCL, ABC, GCB, PMBCL subtypes, transformed indolent lymphomas, or follicular lymphomas
- Received at least one cycle of anthracycline-based chemotherapy given with curative intent
- Age 18 years or older
- At least one measurable disease site 1.5 cm or larger
- ECOG performance status between 0 and 2
- Laboratory tests within specified ranges: ANC ≥ 1500/mm³, platelet count ≥ 100,000/mm³, creatinine clearance ≥ 40 mL/min, total bilirubin ≤ 1.5x ULN (exceptions apply), AST and ALT ≤ 2x ULN
- Women of childbearing potential must agree to dual contraception and have a negative pregnancy test before treatment
- Male patients must use effective barrier contraception if sexually active with females of childbearing potential
- Able to understand and sign informed consent
- Able to follow study visit schedule and protocol requirements
- No serious medical condition, lab abnormality, or psychiatric illness preventing consent
- No condition posing unacceptable risk or confounding data interpretation
- Patients with hepatitis B can enroll if they receive antiviral prophylaxis
You will not qualify if you...
- Not meeting the listed inclusion criteria
- Having primary CNS lymphoma
- Prior treatment with selinexor
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated every 3 weeks for up to 6 cycles or until transplantation eligibility
Participants receive cycles of combination chemotherapy including selinexor, ifosfamide, carboplatin, etoposide, and dexamethasone every three weeks. The dose of selinexor is adjusted during phase 1 to determine the maximum tolerated dose. Participants in phase 2 receive treatment cycles based on the established dose. Those eligible may undergo autologous stem cell transplantation after at least two cycles, while others may receive up to six cycles. Maintenance selinexor may be given after treatment if there is no disease progression.
1 visit every 3 weeks per cycle
Duration - Up to 3 years
Participants are monitored for response to treatment, duration of response, progression-free survival, and overall survival after completing treatment cycles.
Visits scheduled according to study follow-up protocols
Trial Site Locations
Total: 2 locations
1
Samsung Cancer Research Institute
Seoul, South Korea, 135-710
Actively Recruiting
2
Samsung Medical Center
Seoul, South Korea, 135-710
Actively Recruiting
Research Team
S
Seok Jin Kim, MD., PhD
K
Ka Young Song, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here