Overview
This is a phase 2, single center clinical trial. to evaluating the efficacy and safety of Zanubrutinib in combination with R-CHOP in newly diagnosed diffuse large B-cell lymphoma with specific gene abnormality.
Description
This is a phase 2, single center clinical trial. to evaluating the efficacy and safety of Zanubrutinib in combination with R-CHOP in newly diagnosed diffuse large B-cell lymphoma with specific gene abnormality, including MYC translocation, MYD88 mutation, CD79B mutation, NOTCH1 mutation and TP53 mutation. all patients received 6 cycle therapy.
Eligibility
Inclusion Criteria:
- 18-75 years old;
- histological confirmed, newly-diagnosed diffuse large B-cell lymphoma with one of the following gene abnormality including MYC translocation, MYD88 mutation, CD79B mutation, NOTCH1 mutation and TP53 mutation;
- Eastern Cooperative Oncology Group (ECOG) status of 0-1; 4) hospitalized patients and received the whole cycle treatment in Fudan University Shanghai Cancer Center-
- normal hematological, hepatic and renal function.
- Life expectancy of more than 3 months;
- Patients had at least one measurable target lesion;
- LVEF ≥ 50%
- signed informed consent forms
Exclusion Criteria:
- hypersensitivity to immunoglobulin;
- primary central nerves lymphoma
- History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix;
- With contraindication of steroid including uncontrolled diabetes;
- Serious uncontrolled diseases and intercurrent infection;
- Pregnant or lactating women;
- hepatitis B infection with HBV-DNA ≥ 104