Indolent lymphoma
Conditions
Interventions
Experimental group:OZB regimen (Orelabrutinib combined with Zuberitamab and Bendamustine)
Sponsors
Taizhou Central Hospital (Affiliated Hospital of Taizhou University)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years, regardless of gender; patients not suitable for transplantation; 2. Patients with CD20-positive marginal zone lymphoma confirmed by histopathology, including MALT, SMZL, and NMZL; 3. Patients with a definitive diagnosis of CLL/SLL; 4. Patients with mantle cell lymphoma confirmed by WHO histopathology: including mantle cell lymphoma with positive t(11;14) detected by cytogenetics and/or high expression of Cyclin D1 detected by immunohistochemistry; 5. Patients who have not previously received systemic anti-tumor treatment for lymphoma; 6. Measurable lesions detected by enhanced CT/MRI/PET-CT: at least one lymph node with a maximum axis exceeding 1.5 cm and two measurable perpendicular dimensions; 7. ECOG performance status score of 0-2; 8. Major organ function meets the following criteria: a. Hematology without growth factor support or transfusion: neutrophils>= 1.5×10^9/L, platelets>=75×10^9/L, hemoglobin >= 80 g/L; if accompanied by bone marrow involvement, neutrophils >= 1.0×10^9/L, platelets >= 50×10^9/L; b. Biochemistry: total bilirubin <= 2 times ULN, AST or ALT <= 2.5 times ULN; serum creatinine <= 1.5 times ULN; serum amylase <= ULN; c. Coagulation function: international normalized ratio (INR) and activated partial thromboplastin time <= 1.5 times ULN. 9. Voluntary written informed consent signed before screening for the trial.
Exclusion criteria
Exclusion criteria: 1. Patients currently or previously diagnosed with other malignancies, unless they have undergone curative treatment with evidence of no recurrence or metastasis within the past 5 years; 2. Lymphoma involving the central nervous system or transformed to a high-grade subtype; 3. Non-hematological toxicities from previous anti-tumor treatments that have not recovered to = 2+, and 24-hour urinary protein quantification >= 2 g/24 hours; 6. History of deep vein thrombosis or pulmonary embolism within the past 6 months; 7. History of organ transplantation or allogeneic bone marrow transplantation; 8. Major surgical procedures within 6 weeks prior to screening or minor surgical procedures within 2 weeks prior to screening. Major surgery is defined as surgery that used general anesthesia, but diagnostic endoscopic procedures are not considered major surgery. Insertion of vascular access devices will be exempt from this exclusion criterion; 9. Active infection or uncontrolled HBV (HBsAg positive and/or HBcAb positive with positive HBV DNA titer), HCV Ab positive, HIV/AIDS, or other severe infectious diseases; 10. Patients with significant pulmonary dysfunction due to pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, etc.. 11. Previous treatment with BTK, BCR pathway inhibitors (e.g., PI3K, Syk), or BCL-2 inhibitors; 12. Suitable and prepared for stem cell transplantation; 13. Any psychiatric or cognitive disorders that may limit their understanding, execution of the informed consent form, and compliance with the study; 14. Patients with drug addiction or alcoholism; 15. Pregnant or breastfeeding women, and women of childbearing potential unwilling to use contraception; 16. Patients requiring continuous use of drugs with moderate to severe inhibitory or strong inducing effects on cytochrome P450 CYP3A; 17. Any other conditions deemed by the investigator as unsuitable for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete remission rate (CR);Partial response rate(PR);Overall survival(OS);Progression-free survival (PFS);Safety; | — |
Countries
China
Contacts
Public ContactJianlin Chen
Taizhou Central Hospital (Affiliated Hospital of Taizhou University)
Outcome results
None listed