LymphomaNCT05852028
A Real-world Study of Selinexor-based Regimens for Treatment of Non-Hodgkin Lymphoma
An observational study of Lymphoma and DLBCL, run by Ruijin Hospital at 3 sites in China.
Trial summary
This study aims to observe and explore the efficacy and safety of selinexor-based regimen in patients with Non-Hodgkin lymphoma Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lymphoma, DLBCL, T Cell Lymphoma
- What is being tested?
- Selinexor
- How many people
- 250 participants
- Where
- 3 sitesChina
- Study dates
- 15 Dec 2022to 18 Oct 2025
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: DLBCL, T or NK cell lymphoma
Who may be able to join
- Know and voluntarily sign the Informed Consent Form (ICF)
- Clinically confirmed DLBCL, T or NK cell lymphoma
- Patients with DLBCL or T or NK cell lymphoma who have used selinexor-based therapy in the past 3 months are included
- Cooperate with clinical diagnosis and treatment management, and provide disease-related past medical history materials
Who cannot join
- Previously received selinexor
- Poor patient compliance
- physicians evaluate that patients are not suitable for enrollment
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Weili Zhao, M.D. and Ph.D, 13512112076, zhao.weili@yahoo.com
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou
Depei Wu, Prof.
- Recruiting
Union Hospital Affiliated to Huazhong University of Science and Technology
Wuhan
Yu Hu, Prof.
About this study
Official title: A Real-world Study: Efficacy and Safety of Selinexor-based Regimens for Non-Hodgkin Lymphoma
This study aims to observe and explore the efficacy and safety of selinexor-based regimen in patients with Non-Hodgkin lymphoma
Read the detailed description
this study aims to observe and explore the efficacy and safety of selinexor-based regimen in patients with DLBCL or T cell lymphoma. This study is a non-interventional real world, observational study and all registered data are collected from real clinical practice cases. The medical data includes patient demographic, tumor characteristics, laboratory examination, history of treatments, adverse reactions, efficacy results and possible prognostic factors.
- Conditions
- Lymphoma, DLBCL, T Cell Lymphoma
- Being tested
- Selinexor
- Keywords
- SELINEXOR, LYMPHOMA
- Medical subject headings
- Lymphoma, Lymphoma, T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SelinexorDrug
Also called XPO1 inhibitor
this is a real-world. Patients who use selinexor-based regimens in lymphoma will be followed up without interfering with the choice of treatment options for patients
| Study group | Role | What they receive |
|---|---|---|
| selinexor-based regimens | This study is a real-world study to explore the safety and efficacy of selinexor-based therapy in patients with lymphoma. It is planned to enroll 250 patients with lymphoma, including 150 patients with diffuse large B-cell lymphoma and 100 patients with peripheral T and NK/T-cell lymphoma. Receives: Drug: Selinexor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate(ORR)
the percentage of patients with complete response and partial response
Measured: throughout the study, an average of 1 year
incidence of adverse events/ serious adverse events
identify patterns of incidence in adverse events
Measured: throughout the study, an average of 2 year
Secondary outcomes (1)
incidence of dose delays or interruptions
calculate incidence and present the occurrence of dose modifying toxicities by cycles and overall
Measured: throughout the study, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start15 Dec 2022
- Primary completion10 Oct 2024 (estimated)
- Study completion18 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by Ruijin 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Weili, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05852028
- Sponsor's protocol ID
- RJ-XLYM-001
- Status last verified
- May 2023
- First submitted
- 13 Mar 2023
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Study: Efficacy and Safety of Selinexor-based Regimens for Non-Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT05852028
- Acronym / sponsor ID
- RJ-XLYM-001
- Conditions
- Lymphoma, DLBCL, T Cell Lymphoma
- Keywords
- SELINEXOR, LYMPHOMA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 10 Oct 2024 (estimated)
- Study completion
- 18 Oct 2025 (estimated)
- First posted
- 10 May 2023 (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 aims to observe and explore the efficacy and safety of selinexor-based regimen in patients with Non-Hodgkin lymphoma
Detailed description
this study aims to observe and explore the efficacy and safety of selinexor-based regimen in patients with DLBCL or T cell lymphoma. This study is a non-interventional real world, observational study and all registered data are collected from real clinical practice cases. The medical data includes patient demographic, tumor characteristics, laboratory examination, history of treatments, adverse reactions, efficacy results and possible prognostic factors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| selinexor-based regimens | – | Drug: SelinexorThis study is a real-world study to explore the safety and efficacy of selinexor-based therapy in patients with lymphoma. It is planned to enroll 250 patients with lymphoma, including 150 patients with diffuse large B-cell lymphoma and 100 patients with peripheral T and NK/T-cell lymphoma. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- DLBCL, T or NK cell lymphoma
Key inclusion criteria (4 listed)
- Know and voluntarily sign the Informed Consent Form (ICF)
- Clinically confirmed DLBCL, T or NK cell lymphoma
- Patients with DLBCL or T or NK cell lymphoma who have used selinexor-based therapy in the past 3 months are included
- Cooperate with clinical diagnosis and treatment management, and provide disease-related past medical history materials
Key exclusion criteria (3 listed)
- Previously received selinexor
- Poor patient compliance
- physicians evaluate that patients are not suitable for enrollment
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 |
|---|---|---|
| SelinexorAlso: XPO1 inhibitorthis is a real-world. Patients who use selinexor-based regimens in lymphoma will be followed up without interfering with the choice of treatment options for patients | Drug | selinexor-based regimens |
Primary outcome
Objective response rate(ORR)
Time frame: throughout the study, an average of 1 year
the percentage of patients with complete response and partial response
incidence of adverse events/ serious adverse events
Time frame: throughout the study, an average of 2 year
identify patterns of incidence in adverse events
1 secondary outcome
incidence of dose delays or interruptions
Time frame: throughout the study, an average of 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Lymphoma
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Not yet recruitingPhase 1
Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) for Previously Untreated Mantle Cell Lymphoma
Ann Arbor Stage II Mantle Cell Lymphoma, Ann Arbor Stage III Mantle Cell Lymphoma
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma and DLBCL, run by Ruijin Hospital at 3 sites 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 4 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 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
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 Weili Zhao, Prof. (+862164370045 ext. 610707, zwl_trial@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate(ORR) (time frame: throughout the study, an average of 1 year). The study lists 2 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 10 May 2023.