Focus on the Lymphoma Including B/T-cell Lymphoma
Conditions
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.
Interventions
DRUGLinperlisib
80 mg, qd
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Ruijin Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years 2. Clinical diagnosis of lymphoma patients 3. Patients signed informed consent, volunteered to join the study, and had the willingness and ability to cooperate with the data collection in this study; 4. The researchers' assessment can use Linperlisib treatment
Exclusion criteria
1. The nature of the study could not be understood or informed consent was not obtained 2. Other ineligible conditions were assessed by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactWeili Zhao
Outcome results
None listed