CAEBVPhase 3NCT05347381
Selinexol Combined With Dexamethasone in the Treatment of CAEBV
A Phase 3 study testing Selinexol and Dexamethasone in people with CAEBV, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
This study is a single-center, prospective, observational clinical study to evaluate the Effecive and Safty of Selinexol and Dexamethasone in CAEBV Read more about this study
- Who is it for?
- Ages 14 to 70 years
- Conditions the study is for
- CAEBV
- What is being tested?
- Selinexol and Dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 1 Apr 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- -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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
This study is a single-center, prospective, observational clinical study to evaluate the Effecive and Safty of Selinexol and Dexamethasone in CAEBV
- Conditions
- CAEBV
- Being tested
- Selinexol and Dexamethasone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selinexol and DexamethasoneDrug
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;
| Study group | Role | What they receive |
|---|---|---|
| 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; Receives: Drug: Selinexol and Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 6 months
Adverse events
Adverse events including myelosuppression, infection, hemorrhage，vomiting
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start1 May 2022 (estimated)
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CAEBVStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05347381
- Sponsor's protocol ID
- Selinexor；Dexamethasone；CAEBV
- Status last verified
- Apr 2022
- First submitted
- 21 Apr 2022
- Last updated
- 26 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selinexol Combined With Dexamethasone in the Treatment of CAEBV
- ClinicalTrials.gov ID
- NCT05347381
- Acronym / sponsor ID
- Selinexor；Dexamethasone；CAEBV
- Conditions
- CAEBV
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 26 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a single-center, prospective, observational clinical study to evaluate the Effecive and Safty of Selinexol and Dexamethasone in CAEBV
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Selinexol and Dexamethasone | Experimental | Drug: Selinexol and DexamethasoneSelinesol 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; |
Who may qualify
- Ages
- 14 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- -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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Selinexol and DexamethasoneSelinesol 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 |
Primary outcome
EBV-DNA
Time frame: Change from before and 1,3,6 and 9 weeks after initiating Selinexol and Dexamethasone monotherapy
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.
Progression Free Survival
Time frame: 6 months
rom date of inclusion to date of progression, relapse, or death from any cause
Adverse events
Time frame: 6 months
Adverse events including myelosuppression, infection, hemorrhage，vomiting
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Selinexol and Dexamethasone in people with CAEBV, run by Beijing Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact zhao wang, phd (+8615510283692, wangzhao@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EBV-DNA (time frame: Change from before and 1,3,6 and 9 weeks after initiating Selinexol and Dexamethasone monotherapy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2022.