Selinexol Combined With Dexamethasone in the Treatment of CAEBV

NCT ID: NCT05347381

Last Updated: 2022-04-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2025-04-01

Brief Summary

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

Conditions

CAEBV

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Selinexol and Dexamethasone

Selinesol 20mg/tablet 60mg po qw first week, second week, biw third week, namely d1, d8, d15, d18.

Dexamethasone 0.75mg/tablet 1.5mg po bid d1-21;

Group Type: EXPERIMENTAL

Selinexol and Dexamethasone

Intervention Type: DRUG

Selinesol 20mg/tablet 60mg po qw first week, second week, biw third week, namely d1, d8, d15, d18.

Dexamethasone 0.75mg/tablet 1.5mg po bid d1-21;

Interventions

Selinexol and Dexamethasone

Selinesol 20mg/tablet 60mg po qw first week, second week, biw third week, namely d1, d8, d15, d18.

Dexamethasone 0.75mg/tablet 1.5mg po bid d1-21;

Intervention Type: DRUG

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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Friendship Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Friendship Hospital, Capital Medical University

Beijing, , China

Countries

China

Central Contacts

zhao wang, phd

Role: CONTACT

wangzhao@ccmu.edu.cn

+8615510283692

Other Identifiers

Selinexor；Dexamethasone；CAEBV

Identifier Type: -

Identifier Source: org_study_id