Overview
The purpose of this study is to evaluate the efficacy and safety of orelabrutinib combined with rituximab，followed by orelabrutinib combined with R-CHOP-like regimen for newly diagnosed untreated Non-GCB DLBCL Patients
Description
The study will start with an initial 21-days of induction therapy with orelabrutinib and rituximab，following imaging examinations to evaluate response rates. Then treatment with 6 cycles chemoimmunotherapy (R-CHOP-like) either alone or in combination with orelabrutinib will depend on response during induction phase. Each cycle is 21 days.
Eligibility
Inclusion Criteria:
- Histologically confirmed Non-GCB DLBCL
- Age ≥18 and ≤70 years
- At least one measurable lesion，measurable lymph nodes or masses of at least 15 millimeter (mm)
- ECOG performance status 0-2
- Lymphoma International Prognostic Score (IPI) ≥ 2
- Life expectancy ≥ 6 months
- Adequate organ and marrow function
- Agreement to practice birth control from the time of enrollment until the follow-up period of the study
Exclusion Criteria:
- Received major surgery within 4 weeks before treatment or existed unhealed wounds or ulcers, except biopsy related to lymphoma diagnosis
- All patients with primary central nervous system lymphoma
- History of stroke or intracranial hemorrhage within 6 months before screening, require or receive anticoagulant therapy with warfarin or an equivalent antagonist
- Requires treatment with strong /moderate CYP3A inhibitors or inducers
- Uncontrolled comorbidity or complications, including but not limited to: symptomatic congestive heart failure (New York Heart Association Class III-IV) or symptomatic or poorly controlled arrhythmias and/or significant pulmonary disease
- HIV infection and/or active hepatitis B or active hepatitis C infection
- Uncontrolled active systemic infection
- Known hypersensitivity or contraindications to any drug involved in the study
- Pregnant or lactating women