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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)

RecruitingNAAges 14 Years - 80 YearsAllRuijin Hospital
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In plain words

What the trial is, and whether it could suit you

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/Refractory Primary or Secondary Central Nervous System Lymphoma This study adopts an open-label, prospective, single-arm, single-center design aimed at evaluating 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/refractory primary or secondary central nervous system lymphoma (r/r CNSL). Primary Objective To evaluate 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/refractory primary or secondary central nervous system lymphoma (r/r CNSL). Secondary Objec

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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.
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What it tests

  • Selinexor+Orelabrutinib+Methotrexate/Thiotepa/Temozolomide
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Where

1 site
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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