Real World Study of Linperlisib for Lymphoma Treatment
- Conditions
- Focus on the Lymphoma Including B/T-cell Lymphoma
- Interventions
- Registration Number
- NCT05863871
- Lead Sponsor
- Ruijin Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 1000
- 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
- The nature of the study could not be understood or informed consent was not obtained
- Other ineligible conditions were assessed by the investigator
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description all enrolled patients Linperlisib All patient who signed the consent form for participation to the study
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
Complete response rate 6 months Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
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
Trial Locations
- Locations (2)
Tianjin Cancer Hospital/ Tianjin medical university cancer institute & hospital
🇨🇳Tianjin, China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, China