Selinexor in Combination With R-CHOP Followed by Selinexor Maintenance for Untreated EBV-positive DLBCL Patients
EBV-Positive Diffuse Large B-Cell Lymphoma, Nos
About this trial
This is an interventional treatment trial for EBV-Positive Diffuse Large B-Cell Lymphoma, Nos focused on measuring untreated, EBV-positive diffuse large B-cell lymphoma
Eligibility Criteria
Inclusion Criteria:
- Subjects fully understand and voluntarily participate in this study and sign informed consent
- Age ≥18, ≤70 years, no gender limitation.
- Histologically confirmed diagnosis of EBV-positive diffuse large B-cell lymphoma (DLBCL) (more than 50% of tumor cells are positive with EBV encoded small RNAs (EBERs) in situ hybridization were considered EBERs positive).
- Untreated patients, except for the short-time use of prednisone for controlling tumor-induced symptoms (no more than 30mg/d (or other equivalent amounts of other glucocorticoids), no more than 7 days).
- There must be at least one measurable or evaluable lesion that meets the evaluation criteria for Lugano 2014 lymphoma: measurable lesion: Positron emission tomography/computed tomography (PET/CT) or CT and/or MRI, intranodal lesions with long diameter >1.5cm, and short diameter >1.0cm, or extranodal lesions with long diameter > 1.0 cm.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2.
- Expected survival ≥ 3 months.
Adequate function of bone marrow:
White blood cell ≥3.0×10E9/L, absolute neutrophil count ≥1.5×10E9/L Platelet ≥100×10E9/L (Bone marrow invasive patient≥75×109/L) Hemoglobin≥ 90g/L No granulocyte growth factor, platelet, or red blood cell transfusions were received within 14 days prior to examination.
Adequate function of the liver and renal:
Total bilirubin≤2×upper limit of normal (ULN) (patients with liver invasion or Gilbert syndrome ≤5×ULN) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN (patients with liver invasion ≤5×ULN) Serum creatinine ≤1.5×ULN or creatinine clearance rate ≥60 mL/min
- The patients agree to take effective contraceptive measures during the study period and till 12 months after the last administration of the study treatment.
Exclusion Criteria:
- EBV-positive DLBCL combined with other types of lymphoma. Transformed DLBCL.
- EBV-positive DLBCL with central nervous system invasion.
- The patients had previously received XPO1 inhibitors, such as selinexor and so on.
- The patients have contraindications to any drug in the combined treatment.
- The major surgery is performed within 4 weeks before enrollment, except for diagnosis.
- There are any life-threatening diseases, medical conditions or organ system dysfunction that the investigator believes may affect the safety or compliance of patients.
Heart function and disease meet one of the following conditions:
- Heart failure with the classification of New York Heart Association heart function of grade II;
- A history of unstable angina pectoris;
- A history of myocardial infarction within the past 1 years;
- Patients with clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention;
- A history of other malignant tumors within the past 5 years (except the cured cervical cancer and basal cell carcinoma of the skin).
- Patients with active bleeding.
- Uncontrolled infection exists within 7 days before treatment and parenteral antibiotics, antiviral drugs or antifungal drugs are needed; However, preventive use of these drugs (including parenteral anti-infective drugs) is allowed.
- Patients with chronic active hepatitis B or active hepatitis C. If the background hepatitis B Surface Antigen (HBsAg) and/or hepatitis B core Antibody (HBcAb) or hepatitis C Virus (HCV) antibody are positive, the further determination for Hepatitis B Virus (HBV) DNA (no more than 2500 copies /mL or 500 IU/mL) and HCV RNA (no more than the lower limit of the assay) can be included. The patients with HBsAg and/or HBcAb positive need to receive anti-HBV drugs.
- Patients with the infection of human immunodeficiency virus (HIV) and/or acquired Immunodeficiency syndrome.
- Inability to swallow tablets, presence of malabsorption syndrome, or any other gastrointestinal disease or dysfunction that may affect the absorption of the study drug.
- Pregnant and lactating women, and subjects of childbearing age who do not want to use contraception.
- Mentally ill persons or persons unable to obtain informed consent.
- The investigators think that the patient is not suitable for the study.
Sites / Locations
- Sun Yat-sen Universitiy Cancer CenterRecruiting
- Fudan University Shanghai Cancer Center
Arms of the Study
Arm 1
Experimental
Selinexor in Combination With R-CHOP
Patients with untreated EBV-positive diffuse large B-cell lymphoma will receive sequentially higher doses of selinexor in combination with R-CHOP regimen from the second cycle of R-CHOP (3 weeks per cycle).The initial dose of selinexor is 40mg qw po. After 8 cycles of induction therapy, if the response is assessed as complete remission (CR), maintenance therapy with selinexor will be conducted.