Selinexol Combined With Dexamethasone in the Treatment of CAEBV

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

Study Overview

• Status: Not yet recruiting
• Conditions: CAEBV
• Intervention / Treatment: Drug: Selinexol and Dexamethasone

• Study Type: Interventional
• Enrollment (Anticipated): 6
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: zhao wang, phd; Phone Number: +8615510283692; Email: wangzhao@ccmu.edu.cn

Study Locations

• China
  • Beijing, China
    • Beijing Friendship Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 70 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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;	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;

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Beijing Friendship Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 1, 2022
• Primary Completion (ANTICIPATED): April 1, 2025
• Study Completion (ANTICIPATED): April 1, 2025

Study Registration Dates

• First Submitted: April 21, 2022
• First Submitted That Met QC Criteria: April 21, 2022
• First Posted (ACTUAL): April 26, 2022

Study Record Updates

• Last Update Posted (ACTUAL): April 26, 2022
• Last Update Submitted That Met QC Criteria: April 21, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: Selinexor；Dexamethasone；CAEBV

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No