Follicular Lymphoma
Conditions
Interventions
treatment group:zanubrutinib:160mg bid d1-28 po
bendamustine:90 mg/m2 d1-2 iv
obinutuzumab:1000mg d1,8,15 (C1),d1(C2-6)iv
Sponsors
General Hospital of Northern Theater Command of the People's Liberation Army
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Pathologically confirmed diagnosis of Follicular Lymphoma (FL), Grade I, II, or IIIa. 2. Stage II-IV disease. 3. Treatment-naïve patients 4. Presence of measurable and/or evaluable lymphoma lesions. 5. Age >= 18 years and 38°C. Drenching night sweats. Unexplained weight loss > 10% within the past 6 months. Presence of splenomegaly, pleural effusion, ascites, etc. Involvement of vital organs resulting in impaired organ function. Cytopenia (WBC 5.0 × 10^9/L). LDH above the upper limit of normal (ULN). HGB = 3 mg/L. >= 3 nodal or extranodal masses, each >= 3 cm in diameter. Any single lymph node or extranodal mass >= 7 cm in diameter. Increase in size of mass(es) by 20%-30% within 2-3 months. Increase in size of mass(es) by approximately 50% within 6 months. 7. Voluntary participation and provision of written informed consent.
Exclusion criteria
Exclusion criteria: Subjects presenting with any of the following conditions will be excluded from the study: 1. Pathological Grade IIIb or transformed lymphoma. 2. Known HIV infection or active hepatitis B (HBV) or hepatitis C (HCV) infection: a. HBsAg-positive or HBcAb-positive patients:** Only eligible if HBV-DNA is below the lower limit of detection. b. HCV antibody-positive patients:** Only eligible if HCV-RNA is below the lower limit of detection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete response; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall response rate;progression free survival;POD24;OS; | — |
Countries
China
Contacts
Public Contactjinghua liu
General Hospital of Northern Theater Command of the People's Liberation Army
Outcome results
None listed