Clinical trial NCT05347381: Selinexol Combined With Dexamethasone in the Treatment of CAEBV
Official title: Selinexol Combined With Dexamethasone in the Treatment of CAEBV
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: CAEBV
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2022-04-26
Enrollment: 6
Sex: ALL
Minimum age (years): 14
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a single-center, prospective, observational clinical study to evaluate the Effecive and Safty of Selinexol and Dexamethasone in CAEBV


Eligibility criteria: Inclusion Criteria:

-1) Age ≥14 years old, expected survival time is more than 3 months; 2) Any gender 3) CAEBV patients diagnosed by WHO criteria. 4) Eastern Cooperative Oncology Group (ECOG) physical status score of 0-1. 5) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) before the study ≤ 3 × upper limit of normal (ULN); total bilirubin ≤ 2 times the upper limit of normal; serum creatinine ≤ 1.5 times the normal value .

6) Absolute neutrophil count ≥1×109/L; platelets ≥50×109/L; hemoglobin ≥60 g/L. 7) International normalized ratio≤2.0, prothrombin time≤1.5×ULN. 8) Women of childbearing age must be confirmed by a pregnancy test that they are not pregnant, and are willing to take effective contraceptive measures during the trial and ≥ 12 months after the last dose; all male subjects during the study and ≥ 6 months after the last dose use of contraceptive methods; 9) The patients voluntarily joined the study, signed the informed consent, and had good compliance.

Exclusion Criteria:

* 1) There is evidence that EBV progresses to hemophagocytic syndrome; 2) Those who have participated in clinical trials of other drugs within 2 weeks; 3) Those with factors that affect oral drugs (such as inability to swallow, after gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.); 4) Those who have a history of psychotropic substance abuse and cannot quit or have mental disorders; 5) Uncontrolled infection (including lung infection, intestinal infection, etc.); active visceral hemorrhage (including gastrointestinal bleeding, alveolar hemorrhage, intracranial hemorrhage, etc.); and the investigators evaluate patients who will affect the safety of the trial.

  6) Cardiovascular disease of grade ≥2 (New York Heart Association Class 2 cardiovascular disease is defined as subjects who feel comfortable at rest but ordinary physical activity causes fatigue, palpitations, difficulty breathing or angina) 7) There is a significant medical history of renal, neurological, psychiatric, pulmonary, endocrine, metabolic, immune, and liver diseases, and the researcher believes that participating in this study will adversely affect him/her.

  8) Those who are known to be allergic to the study drug or its constituents.

Primary outcomes:
measure: EBV-DNA
timeFrame: Change from before and 1,3,6 and 9 weeks after initiating Selinexol and Dexamethasone monotherapy
measure: Progression Free Survival
timeFrame: 6 months
measure: Adverse events
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
Study officials:
References: