Last updated: December 13, 2023
Sponsor: Sun Yat-sen University
Overall Status: Active - Recruiting
Phase
1/2
Condition
Lymphoma, B-cell
Treatment
R-CHOP Protocol
Selinexor
Clinical Study ID
NCT05577364
B2022-534-01
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Subjects fully understand and voluntarily participate in this study and sign informedconsent
- 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 controllingtumor-induced symptoms (no more than 30mg/d (or other equivalent amounts of otherglucocorticoids), no more than 7 days).
- There must be at least one measurable or evaluable lesion that meets the evaluationcriteria for Lugano 2014 lymphoma: measurable lesion: Positron emissiontomography/computed tomography (PET/CT) or CT and/or MRI, intranodal lesions with longdiameter >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 granulocytegrowth factor, platelet, or red blood cell transfusions were received within 14 daysprior to examination.
- Adequate function of the liver and renal: Total bilirubin≤2×upper limit of normal (ULN) (patients with liver invasion or Gilbertsyndrome ≤5×ULN) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN (patients with liver invasion ≤5×ULN) Serum creatinine ≤1.5×ULN or creatinineclearance rate ≥60 mL/min
- The patients agree to take effective contraceptive measures during the study periodand till 12 months after the last administration of the study treatment.
Exclusion
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 systemdysfunction that the investigator believes may affect the safety or compliance ofpatients.
- Heart function and disease meet one of the following conditions:
- Heart failure with the classification of New York Heart Association heartfunction 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 arrhythmiarequiring treatment or intervention;
- A history of other malignant tumors within the past 5 years (except the cured cervicalcancer and basal cell carcinoma of the skin).
- Patients with active bleeding.
- Uncontrolled infection exists within 7 days before treatment and parenteralantibiotics, antiviral drugs or antifungal drugs are needed; However, preventive useof these drugs (including parenteral anti-infective drugs) is allowed.
- Patients with chronic active hepatitis B or active hepatitis C. If the backgroundhepatitis B Surface Antigen (HBsAg) and/or hepatitis B core Antibody (HBcAb) orhepatitis C Virus (HCV) antibody are positive, the further determination for HepatitisB Virus (HBV) DNA (no more than 2500 copies /mL or 500 IU/mL) and HCV RNA (no morethan the lower limit of the assay) can be included. The patients with HBsAg and/orHBcAb positive need to receive anti-HBV drugs.
- Patients with the infection of human immunodeficiency virus (HIV) and/or acquiredImmunodeficiency syndrome.
- Inability to swallow tablets, presence of malabsorption syndrome, or any othergastrointestinal disease or dysfunction that may affect the absorption of the studydrug.
- Pregnant and lactating women, and subjects of childbearing age who do not want to usecontraception.
- Mentally ill persons or persons unable to obtain informed consent.
- The investigators think that the patient is not suitable for the study.
Study Design
Total Participants: 54
Treatment Group(s): 2
Primary Treatment: R-CHOP Protocol
Phase: 1/2
Study Start date:
November 01, 2022
Estimated Completion Date:
February 28, 2026
Study Description
Connect with a study center
Sun Yat-sen Universitiy Cancer Center
Guangzhou, Guangdong 51000
ChinaActive - Recruiting
Fudan University Shanghai Cancer Center
Shanghai, 200032
ChinaActive - Recruiting


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