Not yet recruiting NCT05863871
Real World Study of Linperlisib for Lymphoma Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Linperlisib.
- Who it may be relevant to
- Registry conditions: Focus on the Lymphoma Including B/T-cell Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Real World Study of Linperlisib for Lymphoma Treatment: Multicenter, Non-interventional and Observational Real-world Study
Overview
This is a multicenter, non-interventional and observational real-world study to evaluate the efficacy and safety of linperlisib in patients with lymphoma.
Interventions
- Drug Linperlisib
80 mg, qd
Primary outcome measures
- Rate of adverse events (AEs)/ serious adverse events (SAEs) [Time frame: up to 4 weeks after the last dose]
Secondary outcome measures (4)
- Complete response rate [Time frame: 6 months]
- Progression-free survival [Time frame: 1 years and 2 years]
- Overall survival [Time frame: Baseline up to data cut-off (up to approximately 2 years)]
- Duration of response [Time frame: Baseline up to data cut-off (up to approximately 2 years)]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 2 centers
- Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai
- Tianjin Cancer Hospital/ Tianjin medical university cancer institute & hospital — Tianjin
Identifiers
NCT: NCT05863871 · E20230190