Overview

The aim of this study is to evaluate the efficacy and safety of the combination of thiotepa and pomalidomide in the treatment of relapsed/refractory (R/R) primary central nervous system lymphoma (PCNSL).

Eligibility

Inclusion Criteria:

        Pathologically confirmed PCNSL, diagnosed according to the 2016 WHO diagnostic criteria.
        Previously treated with at least one course of chemotherapy, with disease progression or
        recurrence.
        Aged 18 to 75 years old; ECOG PS score of 0 to 4 points; Expected survival time of more
        than 3 months; A whole-body PET/CT and head MR (plain scan + enhancement) performed within
        28 days before study enrollment should show at least one measurable lesion in two
        perpendicular directions (based on the 2014 Lugano criteria), or abnormal findings in
        cerebrospinal fluid examination (including cerebrospinal fluid cells, NGS), or ocular
        examination confirming lesions in the retina or vitreous body;
        Adequate organ function, defined as follows:
        Liver function: serum total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); alanine
        aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; Renal function:
        serum creatinine (Cr) ≤ 1 × ULN or creatinine clearance rate (CCR) ≥ 90 mL/min; Cardiac
        function: cardiac function grade of III or less (NYHA standard); echocardiography shows an
        ejection fraction of ≥50%; Coagulation function: international normalized ratio (INR) ≤ 1.5
        × ULN, activated partial thromboplastin time (APTT) ≤ 10s, and prothrombin time (PT) ≤ 3s;
        Thyroid function: baseline thyroid-stimulating hormone (TSH) level is normal or baseline
        TSH is abnormal, but T3/T4 is normal and there are no symptoms; Women of childbearing age
        must take contraceptive measures or undergo a pregnancy test with a negative result before
        enrollment, and take contraceptive measures during the trial and within 90 days after the
        last dose of the drug; for men, contraceptive measures must be taken during the trial and
        within 90 days after the last dose of the drug, or they must have undergone surgical
        sterilization; The subject voluntarily agrees to participate in the study, signs an
        informed consent form, has good compliance, and cooperates with follow-up.
        Exclusion Criteria:
        Pregnant or lactating women; Patients with involvement of sites other than the central
        nervous system; Patients with bone marrow failure, specifically defined as absolute
        neutrophil count (ANC) <1.5 x 109/L, platelets <75 x 109/L, and hemoglobin <70 g/L;
        Patients diagnosed with malignant tumors other than lymphoma or currently undergoing
        treatment, with the following exceptions:
          -  Patients who have received curative treatment and have not had any known active
             malignant tumors for ≥5 years prior to enrollment; ② Patients with adequately treated
             basal cell carcinoma of the skin without evidence of disease (excluding melanoma); ③
             Patients with adequately treated cervical intraepithelial neoplasia without evidence
             of disease.
        Known allergy to any component of the investigational drug; Patients who have undergone
        allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
        Patients who may receive other systemic anti-tumor therapy during the study period;
        Patients with human immunodeficiency virus (HIV) antibodies, active hepatitis, or other
        uncontrolled infectious diseases; Patients with a history of clear neurological or
        psychiatric disorders; Patients who may interfere with the participation of the subject in
        the study or the evaluation of study results due to drug abuse, medical, psychological or
        social conditions; Patients deemed unsuitable for enrollment by the investigator.