Mantle Cell Lymphoma
Conditions
Interventions
Experimental group:Lisaftoclax combined with rituximab and lenalidomide
Sponsors
Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) age >=65 years, ECOG=60 years old, ECOG score 3-4, both sexes; (3) patients with mantle cell lymphoma confirmed by pathology; (4) no previous anti-tumor therapy for lymphoma (5) at least one measurable lesion; (6) predicted survival time =6 months; (7) Normal organ function: 1) Blood routine test without growth factor support therapy or blood transfusion: neutrophil >=1.5×10^9/L, platelet>=75×10^9/L, hemoglobin >=80g/L; If accompanied by bone marrow invasion, neutrophil >=1.0×10^9/L, hemoglobin >=60g/L, platelet >=50×10^9/L; 2) Blood biochemistry: total bilirubin<=2 ULN, AST or ALT<=2.5 ULN; Serum creatinine <=1.5 times ULN; Serum amylase <=ULN; 3) Coagulation: international normalized ratio (INR) and activated partial thromboplastin time <=1.5 times ULN; (8) All subjects voluntarily participated in this clinical trial, signed informed consent, and cooperated with follow-up
Exclusion criteria
Exclusion criteria: (1) Current or past patients with other malignant tumors requiring anti-tumor intervention, unless radical treatment has been performed and there is no evidence of recurrence or metastasis within the past 5 years; (2) Use of antitumor prednisone at a dose of more than 20mg/ day or another equivalent within 7 days before starting the trial drug; (3) Have uncontrolled or major 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 in women and >450ms in men during screening; Or other patients with potential risk of malignant arrhythmia; 4) hypertension difficult to control with conventional drugs; (4) Clinically significant digestive dysfunction, which may affect the intake, transport or absorption of drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.), or total gastrectomy; (5) Patients who received autologous stem cell transplantation (ASCT) within the past 6 months or with relevant active infections after transplantation; (6) History of organ transplantation or allogeneic hematopoietic stem cell transplantation; (7) Underwent major surgery within 6 weeks before screening; (8) Active severe infection or uncontrolled HBV, HCV Ab positive, HIV/AIDS or other serious infectious diseases; (9) Patients with known central nervous system (CNS) involvement (10) Previous or current history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severe impairment of pulmonary function, etc. (11) Any mental or cognitive impairment that may limit the understanding and execution of informed consent and adherence to the study (12) Pregnant, lactating women, or childbearing age subjects who refused to use contraception within 180 days after taking study drug during the entire study period; (13) Any other conditions considered by the investigator to be inappropriate for participation in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy;Bone Marrow MRD; | — |
Countries
China
Contacts
Public ContactLei Fan
Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University
Outcome results
None listed