9/5000 Diffuse large B cell lymphoma
Conditions
Interventions
Case series:treated with Ibitinib combined with methotrexate and temozolomide ±CD20 monoclonal antibody
Sponsors
Fujian Medical University, Union Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. According to the classification of hematopoietic and lymphoid tissue tumors by WHO in 2016, it is confirmed by histological examination as diffuse large B-cell lymphoma and there is no lesion outside the nervous system. 2. Refractory relapse is defined as satisfying any one of the following: (1) Patients treated for the first time undergo at least 2 courses of standard chemotherapy, and the disease is evaluated as PD or SD. (Lugano Evaluation Criteria 2014 Edition); (2) CR was achieved by standard chemotherapy, but relapse occurred within 1 year; (3) Two or more recurrences after 3)CR; (4) relapse after hematopoietic stem cell transplantation; 3. Men or women aged >=18 years at the time of signing the informed consent form; 4. having measurable lesions, defined as >=1 lesion of nervous system with the longest diameter > 1cm; 5. Eastern Tumor Cooperative Organization (ECOG) has a physical fitness score of 0, 1 or 2; 6. Life expectancy >=3 months; 7. Female patients with fertility shall take effective contraceptive measures during the study period and at least 120 days after the last administration, and the serum pregnancy test results shall be negative within 7 days before the administration of the first study drug; 8. Non-sterilized men must agree to take effective contraceptive measures during the study and at least 120 days after the last administration; 9. Can provide written informed consent, and understand and follow the research requirements.
Exclusion criteria
Exclusion criteria: 1. Known HIV infection or active hepatitis C infection; 2. Active fungal, bacterial and/or viral infections requiring systemic treatment exist; 3. Active Mycobacterium tuberculosis infection is known; 4. Clinically important cardiovascular diseases, including the following: Myocardial infarction within 6 months before screening; Unstable angina pectoris within 3 months before screening; New york Heart Association Class III or IV Congestive Heart Failure; Clinically important arrhythmia history (e.g. persistent ventricular tachycardia, ventricular fibrillation, torsade de pointes ventricular tachycardia, atrial fibrillation); 5. Patients with HBsAg positive and HBV DNA >=1000IU/mL shall not be selected. Patients with HBsAg positive but HBV DNA less than 1000 IU/ml and patients with HBsAg negative but HBeAb positive must start antiviral therapy before the first administration of research therapy and undergo monthly HBV DNA screening by PCR; 6. It is known that moderate or strong CYP3A inhibitors are required for the duration of the study; 7. Known to require antiplatelet or anticoagulant therapy during the duration of the study; 8. There are basic medical diseases that researchers and/or medical inspectors believe may lead to the risk of receiving research drugs or lead to difficult interpretation of safety or effectiveness results; 9. Is pregnant or nursing, or intends to be pregnant or have children during the expected test period; 10. Allergy to the three drugs or any auxiliary materials included in the study; 11. Participate in another therapeutic clinical trial at the same time.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| CR;PFS;OS; | — |
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Countries
CHINA
Contacts
Public ContactHaiying FU
Fujian Medical University, Union Hospital
Outcome results
None listed