NCT05863871

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
13mo left

Started May 2023

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
May 2023Jun 2027

Study Start

First participant enrolled

May 1, 2023

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

May 9, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 18, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

May 18, 2023

Status Verified

May 1, 2023

Enrollment Period

4.1 years

First QC Date

May 9, 2023

Last Update Submit

May 9, 2023

Conditions

Focus on the Lymphoma Including B/T-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

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

    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 Outcomes (4)

  • Complete response rate

    6 months

  • Progression-free survival

    1 years and 2 years

  • 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)

Study Arms (1)

all enrolled patients

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

Drug: Linperlisib

Interventions

LinperlisibDRUG

80 mg, qd

Also known as: YY-20394
all enrolled patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Clinical diagnosis of lymphoma

You may qualify if:

  • 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

You may not qualify if:

  • The nature of the study could not be understood or informed consent was not obtained
  • Other ineligible conditions were assessed by the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

Location

Tianjin Cancer Hospital/ Tianjin medical university cancer institute & hospital

Tianjin, China

Location

Central Study Contacts

Weili Zhao

CONTACT

+862164370045zwl_trial@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D. and Ph.D

Study Record Dates

First Submitted

May 9, 2023

First Posted

May 18, 2023

Study Start

May 1, 2023

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

May 18, 2023

Record last verified: 2023-05

Locations

CN(2)