Real World Study of Linperlisib for Lymphoma Treatment (MA-LYM-RWS-001)

May 9, 2023 updated by: Zhao Weili, Ruijin Hospital

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

This is a multicenter, non-interventional and observational real-world study to evaluate the efficacy and safety of linperlisib in patients with lymphoma.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China
        • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
        • Contact:
      • Tianjin, China
        • Tianjin Cancer Hospital/ Tianjin medical university cancer institute & hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Clinical diagnosis of lymphoma

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
all enrolled patients
All patient who signed the consent form for participation to the study
Drug: Linperlisib
80 mg, qd
Other Names:
  • YY-20394

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 4 weeks after the last dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 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.
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)
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
Baseline up to data cut-off (up to approximately 2 years)
Complete response rate
Time Frame: 6 months
Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
6 months
Progression-free survival
Time Frame: 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.
1 years and 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Collaborators

Tianjin Medical University Cancer Institute and Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2023

Primary Completion (Anticipated)

June 1, 2027

Study Completion (Anticipated)

June 1, 2027

Study Registration Dates

First Submitted

May 9, 2023

First Submitted That Met QC Criteria

May 9, 2023

First Posted (Actual)

May 18, 2023

Study Record Updates

Last Update Posted (Actual)

May 18, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E20230190

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The safty of Linperlisib in lymphoma patients

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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