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Clinical Trials/NCT05863871
NCT05863871Not yet recruitingNot Applicable

Real World Study of Linperlisib for Lymphoma Treatment: Multicenter, Non-interventional and Observational Real-world Study

Ruijin Hospital2 sites in 1 country1,000 target enrollmentStarted: May 2023Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
1,000
Locations
2
Primary Endpoint
Rate of adverse events (AEs)/ serious adverse events (SAEs)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

all enrolled patients

All patient who signed the consent form for participation to the study

Intervention: Linperlisib (Drug)

Outcomes

Primary Outcomes

Rate of adverse events (AEs)/ serious adverse events (SAEs)

Time Frame: 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 Outcomes

  • Progression-free survival(1 years and 2 years)
  • Complete response rate(6 months)
  • Overall survival(Baseline up to data cut-off (up to approximately 2 years))
  • Duration of response(Baseline up to data cut-off (up to approximately 2 years))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Zhao Weili

M.D. and Ph.D

Ruijin Hospital

Study Sites (2)

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