Follicular Lymphoma
Conditions
Interventions
Experimental Group:Treatment with zanubrutinib in combination with obinutuzumab and low-dose bendamustine
Sponsors
People‘s Hospital of Xinjiang Uygur Autonomous Region
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Agree to follow the trial treatment protocol and visit schedule, voluntarily enroll, and sign the written informed consent form; 2. Male or female aged =18 years and 38ºC], night sweats, or unintentional weight loss >10% within 6 months or less); (4) Symptomatic extranodal disease (such as pleural effusion, peritoneal ascites); (5) Cytopenia potentially caused by lymphoma (i.e., absolute neutrophil count 6 cm, bone marrow involvement, HGB 60 years); 6. Histologically documented CD20-positive FL, as determined by a local laboratory; 7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2; 8. Adequate hematologic function (unless abnormalities are related to FL) is defined as follows: (1) Hemoglobin >= 9.0 g/dL; (2) Absolute neutrophil count (ANC) >= 1.5 × 10^9/L (unless the investigator determines that neutropenia is directly caused by active lymphoma, in which case ANC must be >= 0.75 × 10^9/L); (3) Platelet count >= 75 × 10^9/L (without growth factor support or transfusion within 7 days); 9. Expected life expectancy >= 12 months; 10. For women who are not postmenopausal (non-therapeutic amenorrhea for more than 12 months) or not surgically infertile (without ovaries and/or uterus)—that is, women of childbearing potential: agree to remain abstinent (avoiding heterosexual intercourse) or use highly effective contraception (with a failure rate of =90 days after the last dose of Zobutizumab or Bendamustine, or 18 months after the last dose of Obinutuzumab (whichever is longer), or use barrier contraception in combination with the other methods listed above.
Exclusion criteria
Exclusion criteria: 1. Relapsed or refractory (R/R) FL; 2. Patients with FL who have previously received any chemotherapy, immunotherapy, or targeted therapy; 3. Grade 3b FL; 4. Histological evidence of FL transformed into high-grade B-cell NHL; 5. Treatment with systemic immunosuppressive drugs within 2 weeks prior to the first dose of the study drug, including but not limited to prednisone/prednisolone/methylprednisolone (equivalent to >30 mg/day prednisone), azathioprine, methotrexate, thalidomide, and anti-TNF agents. Use of inhaled glucocorticoids and mineralocorticoids is allowed. (1) Patients receiving =2 years prior to enrollment without ongoing treatment; 18. Received a live virus vaccine within 28
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete Response Rate (CRR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS);Time to Next Treatment (TTNT);Objective Response Rate (ORR);Proportion of Progression of Disease within 24 Months (POD24);Duration of Response (DOR);Progression-Free Survival (PFS);Safety; | — |
Countries
China
Contacts
Public ContactLi Yan
People‘s Hospital of Xinjiang Uygur Autonomous Region
Outcome results
None listed