lymphoma
Conditions
Interventions
experimental group:Lenalidomide, 25 mg, orally, two weeks
control group:placebo
Sponsors
Fujian Medical University Union Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. According to the WHO classification of hematopoietic and lymphoid tissue tumors in 2016, histologically confirmed diffuse large b-cell lymphoma. 2. The risk of CNS recurrence is defined by reference to the 2020 NCCN guidelines, there were 1 high risk of CNS-IPI (IPI >= 3), 2 HIV infection, 3 MYC, BCL-6, BCL-2 double / triple strike (or expression), 4 large b-cell lymphoma with special extra-nodal Lesions (Testis, breast, uterus, paranasal sinuses, epidural, bone and bone marrow involvement) . 3. Male or female aged over 18 at the time of signing the informed consent. 4. In the early stage of the disease, there were measurable lesions defined as >= 1 lesions with the longest diameter & GT; 1 cm. 5. The ECOG physical fitness score was 0,1, or 2. 6. Life expectancy >= 3 months. 7. Fertile women were required to use high-potency contraception during the study period and at least 120 days after the last dose, and the serum pregnancy test was negative for 7 days prior to the first study. 8. Men who have not been sterilized must agree to effective contraception during the study period and at least 120 days after the last dose. 9. Can provide written informed consent and understand and comply with the requirements of the study.
Exclusion criteria
Exclusion criteria: 1. Known active Hepatitis C infection. 2. There is central infiltration or primary central nervous system diffuse large B cell lymphoma at onset. 3. There are active fungal, bacterial and / or viral infections that require systemic treatment. 4. Active mycobacterium tuberculosis infection is known. 5. Clinically significant cardiovascular disease, including: Myocardial Infarction within 6 months prior to screening; unstable Angina within 3 months prior to screening; Heart Failure III or IV; Clinically significant history of arrhythmias (E.G. persistent ventricular Tachycardia, ventricular fibrillation, Torsades Tachycardia, atrial fibrillation). 6. Patients with HBSAG positive and HBV DNA >= 1000IU / mL were excluded. Patients with HBSAG POSITIVE BUT HBV DNA & Lt; 1000iu / Ml and HBsAg negative but HBsAg positive patients must undergo antiviral therapy and HBV DNA screening by PCR once a month before the first administration of HBEAB. 7. People at high risk for blood clots. 8. Antiplatelet or anticoagulant therapy is known to be required during the duration of the study. 9. There are basic medical conditions that researchers and / or medical inspectors believe may lead to the acceptance of research drugs at risk or lead to safety or efficacy outcomes that are difficult to interpret. 10. Is Pregnant or breast-feeding, or intends to become pregnant or give birth during the anticipated trial period. 11. Allergic to the three drugs included in the study or any of their excipients. 12. And participate in another therapeutic clinical trial. 13. There are contraindications in the directions for lenalidomide.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS;CNS recurrence rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| recurrence rate;OS; | — |
Countries
China
Contacts
Public ContactHaiying Fu
Fujian Medical University Union Hospital
Outcome results
None listed