Newly diagnosed PCNSBL
Conditions
Interventions
Experimental group1:High-dose methotrexate + rituximab + orelabrutinib
Experimental group2:Lenalidomide + rituximab + orelabrutinib
Sponsors
Jiangsu Province Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed newly diagnosed primary central nervous system large B-cell lymphoma; 2. Presence of at least one radiographically measurable lesion defined by the NHL Lugano stage; 3. Eastern Cooperative Oncology Group performance status of 0-4; 4. Signed the inform consent form and able to comply with the scheduled follow-up visits and related procedures required in the protocol. 5. Age >=18 years; 6. Life expectancy>= 12 weeks; 7. Patients (female patients at childbearing age or male patients whose partners are at childbearing age) must take effective contraceptive measures during the entire course of the trial and within 90 days since the last dose of treatment; 8. Adequate organs and bone marrow functions, as defined below: (1) Count of whole blood cells: absolute neutrophil count >= 1.0x10^9/L, platelets >= 50x10^9/L, hemoglobin >= 7.0g/dL; (2) Hepatic function: total bilirubin <= 2xupper limit of normal (ULN), alanine aminotransferase <= 3xULN, aspartate aminotransferase <= 3xULN; (3) Renal function: serum creatinine <= 2xULN.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating patients. 2. Patients have contraindications for any drug involved in the program. 3. Patients enrolled in another interventional clinical study. 4. Received major surgery within two weeks before the first dose of study medication, or has unhealed wounds, ulcers, or fractures. 5. Received any live attenuated vaccine within four weeks before the first dose of study medication, or is scheduled to receive the live attenuated vaccine during the study period. 6. Uncontrolled concurrent diseases including but not limited to: 1) HIV-infected patients; 2) Active pulmonary tuberculosis; 3) Acute and chronic active hepatitis; 4) Symptomatic congestive heart failure (NYHA Class III-IV) or symptomatic or poorly controlled arrhythmia; 5) Any thromboembolic events occurred within three months before enrollment; 6) Any life-threatening bleeding events occurred within three months before enrollment; 7) Acute or chronic diseases, psychiatric disorders, or laboratory abnormalities that may lead to the following consequences: increased investigational drug-related risks, or interference with interpreting trial results, and considered ineligible for participating in the trial by the investigators. 7. Inability to understand or follow research protocols.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall response rate;complete remission rate;overall survival;Safety; | — |
Countries
China
Contacts
Public ContactFan Lei
Jiangsu Province Hospital
Outcome results
None listed