lymphoma
Conditions
Interventions
Testing group:Zanubrutinib combined with Obinutuzumab
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: 1, Patients aged over 65 years, or those over 60 years who are frail. 2, Histopathological diagnosis of follicular lymphoma grades 1, 2, or 3a, with no prior systemic treatment. 3, ECOG performance status score of 0-3. 4, Peripheral blood ANC = 1000/mm³, PLT = 80,000/mm³. For patients with bone marrow involvement, ANC should be = 750/mm³, PLT = 50,000/mm³. 5, Creatinine clearance rate = 30 mL/min. 6, ALT and AST = 3.0 * ULN, total bilirubin = 1.5 * ULN. 7, Signed informed consent.
Exclusion criteria
Exclusion criteria: 1, Known central nervous system involvement of lymphoma. 2, Transformation to diffuse large B-cell lymphoma (DLBCL). 3, History of other malignancies within the past 2 years, except for cured basal cell carcinoma, carcinoma in situ of the cervix, superficial bladder cancer, or localized prostate cancer (GLEASON score of 6). 4, Clinically significant cardiovascular disease: a. History of myocardial infarction within 6 months prior to enrollment. b. History of unstable angina within 3 months prior to enrollment. c. New York Heart Association Class III-IV heart failure. d. Clinically significant arrhythmias, such as sustained ventricular tachycardia, ventricular fibrillation, or torsades de pointes. e. QTcF > 480 ms. f. Second-degree type II AV block or third-degree AV block without a permanent pacemaker. g. Uncontrolled hypertension (systolic BP > 170 mmHg or diastolic BP > 105 mmHg on two consecutive measurements during the screening period). 5, History of severe bleeding disorders, such as hemophilia. 6, History of stroke or intracranial hemorrhage within 6 months prior to enrollment. 7, History of severe pulmonary disease. 8, Inability to swallow tablets or any condition that affects drug absorption in the gastrointestinal tract. 9, Active fungal, bacterial, or viral infections requiring systemic treatment. 10, Known HIV infection or active hepatitis B or C infection: a. Patients with positive HBsAg or HBcAb must have HBV-DNA levels below the lower limit of detection to be eligible. b. Patients with positive HCV antibodies must have HCV-RNA levels below the lower limit of detection to be eligible. 11, Major surgery within 4 weeks prior to enrollment. 12, Live vaccination within 35 days prior to enrollment. 13, Alcohol addiction. 14, Known allergy to Zanubrutinib or Obinutuzumab. 15, Requirement for concomitant use of strong CYP3A inhibitors or inducers. 16, Participation in other interventional clinical trials concurrently. 17, Any other condition deemed unsuitable for inclusion by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CR rate;The MRD (minimal residual disease) negative rate at 24 weeks.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The negative rate of PET/CT at 24 weeks;The progression-free survival (PFS) and safety of patients in two cohorts, either continuing or not continuing maintenance therapy based on multimodal results.; | — |
Countries
China
Contacts
Public ContactFangfang Lv
Fudan University Shanghai Cancer Center
Outcome results
None listed