diffuse large B-cell lymphoma
Conditions
Interventions
Experimental:Orelabrutinib+lenalidomide+Rituximab
Sponsors
Henan Provincial People's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Treatment-na?ve patients with histopathologically confirmed diffuse large B-cell lymphoma, excluding central nervous system lymphoma. 2. ECOG PS 0-3. 3. Patients who are =80 years old or 1.5 cm, or at least one extranodal lesion with the longest diameter > 1.0 cm, and at least two of which can Accurately measured vertical diameter. 5. The main organ functions meet the following conditions: a) Blood routine: (without growth factor support therapy or blood transfusion within 7 days) absolute value of neutrophils =1.5×10^9/L, platelets =50×10^9/L, b) Blood biochemistry: total bilirubin = 2 times ULN, AST or ALT = 2.5 times ULN, c) Creatinine clearance rate = 30ml/min; 6. Patients with a life expectancy of at least 3 months as judged by the investigator. 7. Patients or their legal representatives must provide written informed consent before any special examination or procedure of the study. 8.Previously not receiving treatment for lymphoma (excluding glucocorticoids)
Exclusion criteria
Exclusion criteria: 1. Suffering from other malignant tumors at present or in the past; 2. Patients who have undergone major surgery (examination for diagnostic purposes) or participated in drug/device clinical trials within 4 weeks; 3. Patients with primary central nervous system lymphoma; 4. Uncontrolled or significant cardiovascular disease, including: a) Congestive heart failure above New York Heart Association (NYHA) class II, unstable angina, myocardial infarction within 6 months before the first administration of the study drug, or arrhythmia requiring treatment at the time of screening, left ventricle Ejection fraction (LVEF) 470ms for women and >450ms for men during the screening period; d) Subjects with coronary heart disease who have symptoms or require drug treatment; e) Suffering from difficult-to-control hypertension (on the basis of improving lifestyle, applying a reasonable and tolerable sufficient amount of 2 or more antihypertensive drugs (including diuretics) for more than 1 month and still not reaching the target blood pressure, Or take 4 or more antihypertensive drugs to effectively control blood pressure); 5. Active bleeding within 2 months before screening, or taking anticoagulant drugs, or researchers believe that there is a clear bleeding tendency; 6. Patients with stroke or intracranial hemorrhage within 6 months; 7. Clinically obvious gastrointestinal abnormalities, which may affect the intake, transport or absorption of drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.); 8. Active or uncontrolled HBV (HBsAg positive and HBV-DNA titer positive), HCVAb positive or HIV positive; 9. Uncontrolled, active systemic fungal, bacterial, viral or other infections (defined as showing persistent signs/symptoms associated with infection, which do not improve despite appropriate antibiotics or other treatments); 10. Allergic constitution or hypersensitivity to Obrutinib, Rituximab or any other components of the applicable study drug; 11. Drugs with severe CYP3A inhibition or strong induction must be taken at the same time; 12. Severe mental illness; 13. Pregnant, lactating women and subjects of childbearing age who are unwilling to take contraceptive measures; 14. Those who have poor compliance or cannot be followed up regularly; 15. There are patients who may be life-threatening, or severe organ dysfunction, and the investigator judges that they are not suitable for participating in this trial.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Complete Response rate at cycle 6;overall survival; | — |
Primary
| Measure | Time frame |
|---|---|
| Rate of Progression Free Survival at 3 years; | — |
Countries
China
Contacts
Public ContactZhu Zunmin
Henan Provincial People's Hospital
Outcome results
None listed