Follicular lymphoma
Conditions
Interventions
experimental group:Zanubrutinib + Bendamustine + Rituximab
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients must meet the following criteria to be eligible for the trial: 1. Voluntarily participate and sign the informed consent form; 2. Age >=18 years and =3 months; 4. ECOG performance status score of 0 to 2; 5. Pathologically confirmed diagnosis of follicular lymphoma (FL), grades I, II, or IIIa, previously untreated patients, or patients who have never received systemic treatment, stages III-IV; 6. Measurable and/or evaluable lymphoma lesions (non-radiotherapy target areas) (lesion evaluation according to Recist1.1); 7. No severe dysfunction of major organs (heart, lung, liver, kidney) (refer to respective standards); 8. Hematology parameters: white blood cells (WBC) >=3 × 10^9/L; absolute neutrophil count (ANC) >=1.5 × 10^9/L; platelets (PLT) >=100 × 10^9/L; hemoglobin (Hgb) >=9 g/dL; 9. Blood biochemistry parameters: AST (SGOT), ALT (SGPT) <=2.5 × upper limit of normal (ULN) (in the absence of liver involvement) or <=5 × ULN (in the presence of liver involvement); total bilirubin (TBIL) <=ULN; serum creatinine (CRE) <=1.5 × ULN; 10. Coagulation function: prothrombin time (PT), international normalized ratio (INR) <=1.5 × ULN (unless on warfarin anticoagulation); 11. Able to comply with the study visit schedule and other protocol requirements; 12. All patients of childbearing potential must agree to use effective contraception during the study and for 24 months after stopping treatment. Female patients of childbearing potential must have a negative urine pregnancy test before treatment administration.
Exclusion criteria
Exclusion criteria: Patients will be excluded from this study if they meet any of the following criteria: 1. Grade IIIb follicular lymphoma (FL) and transformed lymphoma; 2. Received treatment for lymphoma within 2 weeks prior to enrollment; 3. History of other malignancies; secondary lymphoma, lymphosarcoma, leukemia occurring after chemotherapy or radiotherapy for other malignancies; central nervous system involvement of lymphoma; 4. Neutrophil count <1.0 × 10^9/L, or hemoglobin <80 g/L, or platelet count <90 × 10^9/L; liver dysfunction unrelated to lymphoma (transaminases exceeding 3 times the upper limit of normal and/or bilirubin greater than 2.0 mg/dL); renal dysfunction unrelated to lymphoma (serum creatinine concentration exceeding 2 times the upper limit of normal); 5. Active infections requiring systemic antibiotic or antiviral treatment, decompensated heart failure, dilated cardiomyopathy, coronary artery disease with ST-segment depression on ECG, myocardial infarction within the last 6 months, severe organic diseases, severe mental disorders; 6. Allergy to any study drug; 7. Pregnant and lactating women; 8. Participation in another clinical study within the last 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete response rate, CRR; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate, ORR;progression-free survival, PFS;overall survival, OS;safety and tolerence; | — |
Countries
China
Contacts
Public ContactHe Huang
Sun Yat-sen University Cancer Center
Outcome results
None listed