DLBCL, Lymphoma, T Cell Lymphoma
Conditions
Keywords
SELINEXOR, LYMPHOMA
Brief summary
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.
Interventions
DRUGSelinexor
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
Sponsors
Ruijin Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Previously received selinexor * Poor patient compliance * physicians evaluate that patients are not suitable for enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate(ORR) | 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 | throughout the study, an average of 2 year | identify patterns of incidence in adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| incidence of dose delays or interruptions | throughout the study, an average of 2 year | calculate incidence and present the occurrence of dose modifying toxicities by cycles and overall |
Other
| Measure | Time frame | Description |
|---|---|---|
| duration of response (DOR) | throughout the study, an average of 2 year | DOR is calculated as the time from initial response (complete response or partial response) to date of progression or death, whichever is earlier |
Countries
China
Contacts
Primary ContactWeili Zhao, Prof.
Backup ContactPengpeng Xu, Prof.
Outcome results
None listed