CNSL
Conditions
Interventions
single arm:rituximab combined with zanubrutinib
Sponsors
Jiangsu Cancer Hospital
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with histologically confirmed central nervous system lymphoma. 2. Male or female patients over 60 years old. 3. Patients with at least one measurable lesion (For intranodal lesions, it was defined as: length diameter >= 1.5cm; For extranodal lesions, the length and diameter were more than 1.0 cm). 4. Patients with ECoG score less than or equal to 3 had an expected survival of more than 3 months. 5. Patients with LVEF >= 50% measured by echocardiography. 6. Patients with sufficient organ and bone marrow function are defined as follows: Blood routine: absolute neutrophil count (ANC) >= 1.0 x 10^9 / L, PLT >= 75 x 10^9 / L, Hgb >= 80g / L; No granulocyte growth factor, recombinant human thrombopoietin, interleukin-11, thrombopoietin receptor agonist, platelet transfusion or red blood cell transfusion was received within 14 days before the examination. Liver function: serum total bilirubin (TBIL) = 30 ml / min (Cockcroft Gault formula). Coagulation function (unless the subject is receiving anticoagulant treatment and the coagulation parameters (Pt / INR and APTT) at the time of screening are within the expected range of anticoagulant treatment): international normalized ratio (INR) <= 1.5 x ULN Activated partial thromboplastin time (APTT) <= 1.5 x ULN. 7. Patients who understand and voluntarily sign the written informed consent. 8. Other researchers believe that MTX based chemotherapy is not suitable for CNSL patients.
Exclusion criteria
Exclusion criteria: 1. The subjects who are allergic to human or mouse monoclonal antibodies have been confirmed to be allergic to zebutinib capsules and / or its excipients. 2. Patients with CNSL progression treated with Btk inhibitors. 3. Patients with a history of malignant tumor. Except for patients with basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or cervical carcinoma in situ who have received a possible curative treatment and have no recurrence within 5 years after the start of treatment. 4. Patients who have recently undergone major surgery (within 4 weeks before the first course of treatment), except for diagnostic surgery. 5. Patients who received anti-cancer Chinese herbal medicine or proprietary Chinese medicine within 7 days before the start of the study. 6. Patients with uncontrollable complications, including but not limited to: severe acute or chronic infection requiring systemic treatment, symptomatic congestive heart failure (NYHA III-IV) or symptomatic or poorly controlled arrhythmia, uncontrolled arterial hypertension (systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 100 mmHg) even after standard treatment, and Unstable angina, active peptic ulcer or hemorrhagic disease. 7. Patients known to have active interstitial pneumonia. 8. Patients with known alcohol or drug abuse. 9. Patients with positive results of chronic hepatitis B infection test (defined as positive results of HBsAg serological test) If HBV DNA could not be detected during screening, patients with latent or previous hepatitis B infection (defined as HBV core antibody positive and HBsAg negative) could be included in this study. These patients must voluntarily undergo a monthly DNA test and receive appropriate antiviral therapy as required. HCV positive (HCV antibody serological test) for patients with HCV antibody positive, only patients with HCV RNA negative by polymerase chain reaction (PCR) can participate in this study. Known history of HIV positive or acquired immunodeficiency syndrome (AIDS); For patients with unknown HIV status, if required by local regulations, HIV screening should be carried out. 10. Subjects who had been vaccinated with live vaccine within 4 weeks before the administration of the study drug were allowed to receive the inactivated virus vaccine for seasonal influenza. 11. For patients receiving continuous corticosteroid therapy, the dose of prednisone > 30 mg / day or equivalent drugs should be continued for more than 10 days (However, hormone therapy for the purpose of dehydration to reduce intracranial pressure (except DXM <= 10mg / day). 12. Patients with active autoimmune diseases requiring systematic treatment in the past two years (hormone replacement therapy is not considered as systematic treatment, such as type I diabetes mellitus, hypothyroidism patients requiring only thyroid hormone replacement therapy Patients with adrenocortical hypofunction or hypopituitarism who only need to receive physiological dose of glucocorticoid replacement therapy can be included in the group, and patients with autoimmune diseases who do not need systematic treatment in the past two years can be included in the group). 13. Dysphagia, unable to take long-term oral medicine. 14. Subjects whose compliance is affected by mental disorders; 15. Subjects without informed consent. 15. Subjects not suitable for the study were judged by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety;ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;OS; | — |
Countries
China
Contacts
Public ContactWu Jianqiu
Jiangsu Cancer Hospital
Outcome results
None listed