MA-LYM-RWS-001: Real World Study of Linperlisib for Lymphoma Treatment
Study Details
Study Description
Brief Summary
This is a multicenter, non-interventional and observational real-world study to evaluate the efficacy and safety of linperlisib in patients with lymphoma.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| all enrolled patients All patient who signed the consent form for participation to the study |
Drug: Linperlisib
80 mg, qd
Other Names:
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Outcome Measures
Primary Outcome Measures
- Rate of adverse events (AEs)/ serious adverse events (SAEs) [up to 4 weeks after the last dose]
Rate of adverse events (AEs)/ serious adverse events (SAEs) in patients with lymphoma receiving linperlisib therapy
Secondary Outcome Measures
- Complete response rate [6 months]
Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
- Progression-free survival [1 years and 2 years]
Progression-free survival was defined as the time from the date of enrollment until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.
- Overall survival [Baseline up to data cut-off (up to approximately 2 years)]
Overall survival was defined as the time from the date of enrollment to the date of death from any cause.
- Duration of response [Baseline up to data cut-off (up to approximately 2 years)]
Duration of response was defined as the time from the date of favorable response until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age ≥18 years
-
Clinical diagnosis of lymphoma patients
-
Patients signed informed consent, volunteered to join the study, and had the willingness and ability to cooperate with the data collection in this study;
-
The researchers' assessment can use Linperlisib treatment
Exclusion Criteria:
-
The nature of the study could not be understood or informed consent was not obtained
-
Other ineligible conditions were assessed by the investigator
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ruijin Hospital, Shanghai Jiao Tong University School of Medicine | Shanghai | China | ||
| 2 | Tianjin Cancer Hospital/ Tianjin medical university cancer institute & hospital | Tianjin | China |
Sponsors and Collaborators
- Ruijin Hospital
- Tianjin Medical University Cancer Institute and Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- E20230190