Mantle cell lymphoma
Conditions
Interventions
Experimental group:OR2 scheme
Sponsors
Qilu Hospital of Shandong University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. No gender limitation, aged >=65 years; Or aged =1.5x10^9/L, platelets >=75x10^9/L, hemoglobin >=80g/L; If accompanied by bone marrow invasion, neutrophils >=1.0x10^9/L, platelets >=50x10^9/L; (2) Blood biochemistry: total bilirubin <=2 ULN, AST or ALT<=2.5 ULN; Serum creatinine <= 1.5x ULN; Serum amylase <=ULN; (3) Coagulation function: International standardized ratio (INR) and activated partial thrombin time <=1.5 times ULN; 7. A written informed consent was voluntarily signed before screening.
Exclusion criteria
Exclusion criteria: 1. Patients currently or previously suffering from other malignancies requiring anti-tumor intervention, unless radical therapy has been performed and there is no evidence of recurrence and metastasis in the last 5 years; 2. Use more than 20mg/ day of prednisone for antitumor purposes or other equivalent within 7 days prior to initiation of the trial drug; 3. Have uncontrolled or significant cardiovascular disease, including: (1) New York Heart Association (NYHA) Class II or higher congestive heart failure, unstable angina, myocardial infarction, left ventricular ejection fraction (LVEF) 470ms for women and >450ms for men; Or other potential risk for malignant arrhythmias; (4) Hypertension difficult to be controlled by conventional drugs; 4. Active bleeding within 2 months prior to screening, or taking anticoagulant/platelet drugs, or a definite tendency to bleed (e.g., esophageal varicose veins at risk of bleeding, locally active ulcerative lesions) as determined by the investigator; 5. Urinary protein >=2+ and 24-hour quantitative test of urinary protein >=2g/ 24h; 6. History of deep vein thrombosis or pulmonary embolism; 7. Clinically significant digestive dysfunction, which may affect drug intake, transport or absorption (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.), or total gastrectomy; 8. Patients who received autologous stem cell transplantation within the previous 6 months or had associated active infections after transplantation; 9. History of organ transplantation or allogeneic hematopoietic stem cell transplantation; 10. Major surgical operations have been performed within 6 weeks prior to screening, but tests for diagnostic purposes are not considered surgical. Insertion of vascular access devices will be exempt from this exclusion criteria; 11. Active serious infection or uncontrolled HBV (HBsAg positive and/or HBc Ab positive and HBV DNA titer positive), HCV Ab positive, HIV/AIDS (Acquired Immune Deficiency Syndrome) or other serious infectious diseases; 12. Previous or current history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe impairment of lung function, etc.; 13. Any mental or cognitive impairment that may limit the understanding, implementation and compliance with the informed consent; 14. Drug and alcohol abuse; 15. Pregnant and lactating patients, or patients of childbearing age who did not want to use contraception within 180 days of taking study drugs during the study period to the end of the study; 16. Other conditions deemed unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate;Complete remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall survival;Time to next treatment;MRD negative rate;Safety; | — |
Countries
China
Contacts
Public ContactJi Chunyan
Qilu Hospital of Shandong University
Outcome results
None listed