Follicular lymphoma
Conditions
Interventions
BG-ZG:BG regimen followed by ZG regimen
Sponsors
The First Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The subjects voluntarily joined the study and signed the informed consent; 2. Age =18 years old, gender unlimited; 1.ECOG (PS) score: 0-2; 2.Expected survival =3 months; 3. Histopathologically diagnosed with grade 1-3a follicular lymphoma (FL), Ann Arbor III/IV with treatment indications or stage II or II with a large mass unsuitable for radiotherapy; 4. No previous treatment for lymphoma; 5. CT/PET-CT or MRI evaluation showed the presence of at least one radiographically measurable lymph node or extranodal lymphoma lesion; 6. The main organ functions during the screening period met the following criteria: 1) blood routine examination criteria (no growth factor or transfusion was used within 7 days) : neutrophil absolute value (ANC)=1.5x10^9/L; 3.Lymphocyte count (LYM)=0.5x10^9/L; 4.Platelet (PLT)=75x10^9/L (patients with lymphoma bone marrow infiltration =50x10^9/L were allowed to be included); 5.Hemoglobin (Hb)=80g/ L; 2) Blood biochemical test criteria: ALT and AST =2.5xULN (lymphoma involving liver or biliary obstruction, =5xULN); 6.Serum total bilirubin (TBIL)=1.5xULN; 7.Serum creatinine (Cr)=1.5xULN or creatinine clearance =50ml/ min; 3) Coagulation function test criteria: activated partial thromboplastin time (APTT), International standardized ratio (INR), prothrombin time (PT)=1.5xULN; 7. The woman is not breastfeeding, is using highly effective contraception, is not pregnant, and has agreed not to become pregnant during and for 18 months after participating in the trial (premenopausal women must undergo a pregnancy test); 8. Women should consent to use highly effective birth control (IUD, pill or condom) during the study period and for 18 months after the study; 8.Serum or urine pregnancy tests were negative before study enrollment and must be non-lactating subjects; 9.Men should agree that contraception must be used during the study period and for 18 months after the study ends; 9. Sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Follicular lymphoma transformed into diffuse large B-cell lymphoma; 2. Lymphoma patients with central nervous system (CNS) invasion; 3. Patients who have previously received other BTK inhibitors or organ, bone marrow, or peripheral blood stem cell transplantation; 4.Present with other malignancies within the past 3 years or in present, except cured thyroid cancer, cervical cancer, non-melanoma skin cancer and superficial bladder tumors; 5. Hypersensitivity to any investigational drug; 6. Regular use of corticosteroids within the past 4 weeks, unless the dose is equivalent to <20 mg/ day of prednisone; 7. Concurrent use of potent CYP3A4 inhibitors and/or oral anticoagulants (warfarin and/or phenylcoumarin); 8. Serious underlying diseases that interfere with routine treatment in this study protocol; 9. Received live vaccine or major surgery (except diagnostic) within 28 days prior to first receiving the investigational drug; 10. History of stroke or intracranial hemorrhage within 6 months before enrollment; 11. Serious underlying medical conditions that may impair the patient's ability to receive the treatment offered in the study (e.g., persistent infections, gastric ulcers, active autoimmune diseases); 12. Treatment in clinical trials within 30 days prior to enrollment; 13. Other circumstances deemed unsuitable for participation in this study by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CRR; | — |
Secondary
| Measure | Time frame |
|---|---|
| CRR 6 months after completion of combination therapy;ORR;PFS;OS;POD24;DOR;TRAE; | — |
Countries
China
Contacts
Public ContactPengcheng He
The First Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed