Selinexol Combined With Dexamethasone in the Treatment of CAEBV

CAEBV Clinical Trial

Official title:

Selinexol Combined With Dexamethasone in the Treatment of CAEBV

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05347381
• Other study ID #: Selinexor;Dexamethasone;CAEBV
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: May 1, 2022
• Est. completion date: April 1, 2025

Study information

• Verified date: April 2022
• Source: Beijing Friendship Hospital
• Contact: zhao wang, phd
• Phone: +8615510283692
• Email: wangzhao[@]ccmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 6
• Est. completion date: April 1, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• CAEBV

Intervention

Drug:
• 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;

Locations

Country	Name	City	State
China	Beijing Friendship Hospital, Capital Medical University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EBV-DNA	Treatment effectiveness is defined: EBV-DNA copies/ml in peripheral blood turns negative, and the involved tissues (such as lymph nodes, bone marrow, skin, etc.) are negative in EBER test or the EBV copy number has decreased by more than 2 orders of magnitude, but it is still positive.	Change from before and 1,3,6 and 9 weeks after initiating Selinexol and Dexamethasone monotherapy
Primary	Progression Free Survival	rom date of inclusion to date of progression, relapse, or death from any cause	6 months
Primary	Adverse events	Adverse events including myelosuppression, infection, hemorrhage,vomiting	6 months