Prospective, Multicenter, Single-arm Clinical Study of Orelabrutinib Plus Rituximab for Second-line Treatment of Relapsed/Refractory Marginal Zone Lymphoma
The goal of this clinical trial is to test the overall response rate of Orelabrutinib combined with rituximab (OR regimen) for second-line treatment of relapsed/refractory marginal zone lymphoma.
• Age: 18 years, 80, Sex gender no limitied;
• histological confirmation of MZL, For splenic marginal zone lymphoma (SMZL) where histological specimens of the spleen were not available, Requirements to meet the minimum diagnostic criteria for SMZL, And exclude any other type of small B cell lymphoma, That is, requiring a definite diagnosis of MZL;
• at least one two-dimensional measurable lymph node lesion (CT scan or MR / display maximum diameter\> 1.5cm), Or at least one two-dimensional measurable extranodal lesion (CT scan or MRI showing maximum diameter\> 1.0cm);
• the investigator required systemic treatment for marginal zone lymphoma;
• at least 1 previous course of systemic lymphoma treatment (including previous immunotherapy or chemoimmunotherapy), 3 without efficacy above PR after imaging evaluation, Or disease progression after effective treatment;
• ECOG, physical strength score 0-2;
• primary organ function meets the following criteria 7 days prior to treatment:
∙ blood routine: absolute neutrophil ≥1.5x10\^9 / L, Platelet≥ 75x10\^9 / L, Hemoglobin≥75g / L; If the concomitant bone marrow invasion, Absolute neutrophil value ≥1.0x10\^9 / L, Platelet≥50x10\^9 / L, Hemoglobin≥ 50g / L;
‣ Blood Chemistry: total bilirubin ≤1.5 times ULN, AST or ALT ≤2 times ULN; If the liver is infiltrated with a lymphoma, Then, ALT and AST ≤5 times ULN, Serum creatinine ≤ 1.5 times ULN or creatinine clearance ≥45 ml/min (Cockcroft-Gault formula); Serum amylase ≤ULN;
‣ coagulation function: International normalized ratio (INR) ≤1.5 times ULN, Activated partial thromboplastin time (APTT)≤ 1.5 times ULN.
‣ cardiac color ultrasound: left ventricular ejection fraction 50%;
• expected survival time of 3 months;
• for men who did not undergo sterilization: agree to use the barrier contraceptive method during treatment and for at least 3 months after the last administration of obutinib or rituximab or on the older) as required in the guidelines established by the institution. In addition, male patients must agree to request their spouses to use other methods of contraception (e. g., oral contraceptives, intrauterine devices, barrier contraception, or spermicide).
⁃ For women who did not undergo sterilization: at least 28 days prior to consent to start study medication, during treatment, or after last administration of obutinib or rituximab, such as oral contraceptives, intrauterine devices or barrier contraception;
⁃ voluntarily signed written informed consent before test screening.