Status:
RECRUITING
A Clinical Study on the Efficacy and Safety of Methotrexate (MTX) or Thiotepa (for MTX Intolerance) or Temozolomide (TMZ) Combined With Orelabrutinib and Selinexor in Relapsed/Refractory Primary or Secondary Central Nervous System Lymphoma（SELINA）
Lead Sponsor:
Ruijin Hospital
Conditions:
Lymphoma Cns
Eligibility:
All Genders
14-80 years
Phase:
NA
Brief Summary
Clinical Study on the Efficacy and Safety of Methotrexate (MTX) or Thiotepa (for MTX intolerance) or Temozolomide (TMZ) Combined with Orelabrutinib and Selinexor in the Treatment of Relapsed/Refractor...
Detailed Description
1. Research Background 1.1 Significance of the Research Central nervous system lymphoma (CNSL) is a rare extranodal non-Hodgkin lymphoma characterized by high aggressiveness and poor prognosis. Ov...
Eligibility Criteria
Inclusion
- Patients must meet all of the following criteria to be enrolled in this study:
- Fully understand this study and voluntarily sign the informed consent form;
- Age: 14-80 years;
- Life expectancy judged by the investigator to exceed 3 months;
- B-cell origin central nervous system lymphoma (CNSL) confirmed by pathology or flow cytometry (histology or cytology);
- Relapsed or refractory PCNSL or SCNSL: Must have received at least one prior systemic therapy for CNS lesions; number of relapses is not restricted;
- Any non-hematological toxicity related to prior treatment should have recovered to Grade 1 or normal (according to NCI CTCAE version 5.0, except alopecia).
- Bone marrow and organ function meeting the following criteria (no transfusion, no G-CSF use, no medication for correction within 14 days before screening):
- Bone marrow function: Absolute neutrophil count ≥1.0x10⁹/L, platelets ≥50x10⁹/L, hemoglobin ≥60g/L;Liver function: Serum total bilirubin ≤1.5xULN (≤3.0xULN if liver metastases present); AST and ALT ≤ 2.5xULN (≤5.0xULN if liver metastases present);Coagulation function: International Normalized Ratio (INR) and activated partial thromboplastin time ≤1.5xULN;Renal function: Serum creatinine ≤1.5xULN or estimated creatinine clearance ≥30 mL/min (Male: Cr (mL/min) = (140 - age) x weight (kg) / (72 x serum creatinine (mg/dL)); Female: Cr (mL/min) = (140 - age) x weight (kg) / (85 x serum creatinine (mg/dL))).
- Female subjects of childbearing potential and male subjects with reproductive ability, who have no pregnancy plan with their partners during the study period and for 3 months after treatment interruption, must use one of the following effective contraceptive methods throughout the study and for 3 months after treatment interruption: abstinence, physical contraception (e.g., ligation, condoms, etc.), hormonal contraceptive drugs started at least 3 months before the first dose in the study. Male subjects are prohibited from sperm donation from the start of treatment until 3 months after treatment cessation. The patient or their legal guardian voluntarily signs the informed consent form.
- Good compliance, willing to adhere to the visit schedule, dosing plan, laboratory tests, and other trial procedures.
Exclusion
- Patients who meet any of the following criteria will not be allowed to enter this study:
- Contraindication to any drug in the treatment regimen;
- Subject has a history of active liver disease, including viral or other hepatitis or cirrhosis (Hepatitis B defined as HBV-DNA above the upper limit of normal; active Hepatitis C defined as seropositive for HCV antibody, but those with negative HCV-RNA can be enrolled);
- Human Immunodeficiency Virus (HIV) infection;
- Congestive heart failure (New York Heart Association Class \>2); history of acute myocardial infarction, unstable angina, stroke, or transient ischemic attack within the past six months;
- Hereditary long QT syndrome or QTc \>480ms (Note: QTc interval must be calculated using Fridericia's formula, QTcF = QT/(RR)\^0.33);
- Pregnant and lactating women, or those planning to become pregnant during the study period;
- Clear history of neurological or psychiatric disorders, or history of psychotropic drug abuse or drug addiction;
- Clinically significant active infection.
Key Trial Info
Start Date :
September 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 2 2029
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT07191431
Start Date
September 22 2025
End Date
September 2 2029
Last Update
September 24 2025
Active Locations (1)
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1
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China