Follicular lymphoma
Conditions
Interventions
1:Zanubrutinib in combination with obinutuzumab
Sponsors
The First Affiliated Hospital of Xiamen University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age: >= 18 years old, gender is not limited; 2.Follicular lymphoma with a definite diagnosis according to the REAL/WHO classification, stages II-IV requiring treatment according to the GELF rule; 3.ECOG 0-2; 4.Using the Lugano 2014 lymphoma efficacy evaluation criteria, there must be at least one measurable or evaluable lesion: signed informed consent, recruited subjects according to inclusion and exclusion criteria, etc. History and pre-treatment baseline examination and registration on the case report form (CRF) ZO regimen chemotherapy for 6 cycles, followed by zanubrutinib monotherapy orally for 6 months Follow-up assessment (including safety) follow-up assessment (including safety) once every three months 1. Achieve PR and above efficacy, and use zanubrutinib maintenance therapy 12 months, and the rest will be treated with second-line treatment (recommended according to NCCN guidelines) Evaluate the efficacy Evaluate the efficacy Evaluate the efficacy, that is, PET/CT has evaluable lesions; CT or MR assessment of intranodal lesions greater than 1.5 cm in length, short diameter greater than 1.0 cm, or extranodal lesions > 1.0 cm in diameter; 5.Huff-positive serology (occult carriers: anti-Hebsag+, Hebsag-, anti-Hebsag +/-) can only be enrolled if the Huff-Dana test is negative; 6.Normal function of major organs: 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 (all studies must sign the patient's informed consent form).
Exclusion criteria
Exclusion criteria: 1.Medically significant central nervous system lymphoma or leptomeningeal disease or large cell transformation; 2.HIV-positive patients and/or HCV active infection (documented by HCV-RNA positive test); 3.Patients should not have active or uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia, patients should not have transfusion-dependent thrombocytopenia, or bleeding disorders, patients should not have autoimmune diseases associated with the study drug; 4.Known bleeding disorder (e.g,von Willebrand disease or hemophilia) requiring treatment with a potent cytochrome P450 (CYP)3A inhibitor in combination with warfarin or other vitamin K antagonists; 5.Patients with acute coronary syndrome within 6 months prior to enrollment in the study, and must not have had stroke or intracranial hemorrhage in the past 6 months Previous surgery: no major surgery within 28 days prior to enrollment, or no minor surgery within 7 days prior to enrollment; Examples of minor surgeries include dental surgery, venous access instrument insertion, skin biopsy, or joint aspiration; It is up to the treating physician to decide whether the surgery is major or minor; 6.Severe chronic obstructive pulmonary disease with hypoxemia; 7.Active bacterial, fungal, and/or viral infections not controlled by systemic therapy; 8.In addition to cured basal cell carcinoma of the skin or cervical carcinoma in situ or early-stage prostate cancer that does not require systemic treatment, or early-stage breast cancer that requires surgery alone. Other malignancies within the last 2 years or concomitantly; 9.Pregnancy and lactation: Female patients must have a negative serum pregnancy test result within 72 hours prior to initiation of protocol therapy and use effective contraception during protocol therapy and for at least 12weeks after completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 2-year progression-free survival;Overall survival rate; | — |
Countries
China
Contacts
Public ContactBingXu
The First Affiliated Hospital of Xiamen University
Outcome results
None listed