Follicular Lymphoma, Newly Diagnosed
Conditions
Brief summary
To evaluate the efficacy and side effects of Zanubrutinib combined with Obinutuzumab (ZO) in the treatment of newly diagnosed follicular lymphoma.
Detailed description
Zanubrutinib (Z) 160mg bid oral d1-21 Obinutuzumab (O) C1 1000mg d1,8,15 C2-C6 d1 IV, then every 8 weeks until full 20 infusions (1 year maintenance)
Interventions
DRUGZanubrutinib combined with Obinutuzumab
Zanubrutinib combined with Obinutuzumab (ZO), a specific dose on specific days.
Sponsors
Shanxi Provincial Cancer Hospital
The First Hospital of Jilin University
Fujian Cancer Hospital
Jiangxi Provincial Cancer Hospital
The Second Affiliated Hospital of Dalian Medical University
Sun Yat-sen University
Huazhong University of Science and Technology
The First Affiliated Hospital of Xiamen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age: ≥18 years old and gender-neutral; 2. Follicular lymphoma definitively diagnosed according to the REAL/WHO classification, stage II-IV requiring treatment according to the GELF code; 3. ECOG score 0-2; 4. Lymphoma efficacy evaluation criteria using Lugano 2014 Lymphoma must have at least one measurable or evaluable lesion: signed informed consent, subjects recruited based on inclusion and
Exclusion criteria
, etc History taking and pre-treatment baseline examination and registration on case report form (CRF) ZO regimen of chemotherapy for 6 cycles, followed by zebrutinib monotherapy orally for 6 months, with observation of toxicities Follow-up assessment (including) Follow-up evaluation (including safety) \<Blood, biochemistry, B2-MG, neck, chest and abdomen CT plain + enhanced, questionnaire\> Follow-up evaluation (including safety) \<Blood, biochemistry, B2-MG, neck, chest and abdomen CT plain + enhanced, questionnaire, once every three months\> 1. Zerbutinib maintenance treatment for 12 months for PR and above 2. Second-line treatment for the rest of the patients (recommended by NCCN guidelines) NCCN guideline recommendation) Assessment of efficacy i.e. PET/CT with evaluable lesions; CT or MR evaluation of intranodal lesions with a long diameter \>1.5cm, short diameter \>1.0cm or extranodal lesions with a long diameter \>1.0cm; 5. HBV-positive serology (concealed carriers: anti-HBeAg +, HbsAg-, anti-HBsAg +/-) Enrollment only if HBV-DNA test is negative; 6. Normal major organ function: liver function serum bilirubin ≤ 2.0 × ULN , serum ALT and AST ≤ 2.5 × ULN, renal function: serum Cr ≤ 2.0 × ULN; (unless due to lymphoma); 7. Informed consent (patients must sign an informed consent form for all studies).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CR | up to 1 year | Complete remission rate |
Countries
China
Contacts
Primary ContactBing Xu, PhD
Outcome results
None listed