Selinexol Combined With Dexamethasone in the Treatment of CAEBV

NCT05347381 | Unknown Phase 3

• 1 other identifier: Selinexor；Dexamethasone；CAEBV
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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

• Progression Free Survival

  rom date of inclusion to date of progression, relapse, or death from any cause

  6 months

• Adverse events

  Adverse events including myelosuppression, infection, hemorrhage，vomiting

  6 months

Study Arms (1)

Selinexol and Dexamethasone

EXPERIMENTAL

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;

Drug: Selinexol and Dexamethasone

Interventions

Selinexol and Dexamethasone 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;

Selinexol and Dexamethasone

Eligibility Criteria

• Age: 14 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ) 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 .
• \) 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.

You may not qualify if:

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

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, China

Location

MeSH Terms

Interventions

Dexamethasone

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

zhao wang, phd

CONTACT

+8615510283692; wangzhao@ccmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: April 26, 2022
• Study Start: May 1, 2022
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: April 26, 2022

Record last verified: 2022-04

Locations

CN (1)