Status:
RECRUITING
Selinexor With ICE Chemotherapy in Secondary Central Nervous System Involving B-cell Non-Hodgkin Lymphoma
Lead Sponsor:
Samsung Medical Center
Collaborating Sponsors:
Korean Society of Hematology
Conditions:
B-cell Lymphoma Recurrent
B-cell Lymphoma Refractory
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 lymp...
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 wit...
Eligibility Criteria
Inclusion
- 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
- Patients cannot fulfill the above-mentioned inclusion criteria
- Patients with primary CNS lymphoma
- Patients with a prior history with selinexor
Key Trial Info
Start Date :
May 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2027
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT06552559
Start Date
May 1 2024
End Date
December 30 2027
Last Update
August 14 2024
Active Locations (2)
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1
Samsung Cancer Research Institute
Seoul, South Korea, 135-710
2
Samsung Medical Center
Seoul, South Korea, 135-710