Double expression diffuse large B-cell lymphoma
Conditions
Interventions
Experimental group:Obutinib combined with immunotherapy
Sponsors
Harbin First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Age>=18 years old, = 80 years old, gender not limited; 2.Newly diagnosed diffuse large B-cell lymphoma (DLBCL) with a C-MYC cut-off value of >= 40% and BCL2 cut-off value of >= 50% confirmed by central pathology; 3.At least one measurable lesion (lymph node lesion with a length diameter >= 1.5 cm, extranodal lesion with a length diameter >= 1.0 cm); 4.Expected survival time >= 6 months; 5.ECOG physical status score is 0, 1, or 2 points; 6.International Prognostic Index (IPI) >= 2 points or IPI=1 point with large mass; 7.Voluntarily sign a written informed consent form before experimental screening;
Exclusion criteria
Exclusion criteria: 1.Previously received systemic or local treatment, including chemotherapy; 2.Previously received autologous stem cell transplantation; 3.History of other malignant tumors in the past, excluding basal cell carcinoma of the skin and in situ uterine cancer; 4.Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases and other diseases; 5.Lymphoma involving the central nervous system; 6.Primary mediastinal large B-cell lymphoma; 7.Known rearrangement of the BCL2 gene combined with the MYC gene; or known mutation of the TP53 gene. (If relevant genetic tests have not been performed, the default assumption is no genetic abnormalities.); 8.LVEF 2 × ULN, ALP and bilirubin > 1.5 × ULN; (4) Creatinine > 1.5 × ULN. 11.Patients with psychiatric disorders, or other patients known or suspected of being unable to fully adhere to the study protocol; 12.Pregnant or lactating women; 13.Known human immunodeficiency virus (HIV) infection, or active hepatitis B or hepatitis C virus infection (positive result by polymerase chain reaction [PCR]). For patients with a positive HBsAg test result, an HBV DNA test is required. If HBV DNA < 10^3 IU/mL, the patient may be enrolled. If HBsAg test result is negative but HBcAb test is positive (regardless of HBsAb status), an HBV DNA test is also required. If HBV DNA < 10^3 IU/mL, the patient may be enrolled. If the patient tests positive for HCV antibody, PCR technology will be used to detect HCV RNA. A positive result meets the exclusion criteria; 14.Requires continuous treatment with potent and moderate CYP3A inhibitors or CYP3A inducers; 15.Inability to swallow capsules or presence of diseases significantly affecting gastrointestinal function, such as malabsorption syndrome, bariatric surgery, inflammatory bowel disease, or partial or complete intestinal obstruction; 16.Other concurrent and uncontrolled medical conditions that, in the investigator's opinion, would affect the patient's participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete remission rate;Complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Progression-free survival; | — |
Countries
China
Contacts
Public ContactMa Jun
Harbin First Hospital
Outcome results
None listed