Recruiting

A Multicenter, Prospective, Single-arm Clinical Study on the Treatment of Refractory/Relapsed Follicular Lymphoma (R/RFL) With Chidamide Combined With Linperlisib

What is being tested

Chidamide combined with Linperlisib

Drug

Who is being recruted

Hemic and Lymphatic Diseases+8

+ Immune System Diseases

+ Immunoproliferative Disorders

Over 18 Years

+28 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2

Interventional

Study Start: November 2023

See protocol details

Summary

Principal SponsorThe First Affiliated Hospital of Xiamen University

Study ContactBing XuMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: November 22, 2023

Actual date on which the first participant was enrolled.

This clinical trial is focused on finding out how effective and safe a combination of two drugs, Chidamide and Linperlisib, is in treating follicular lymphoma that has not responded to previous treatments or has come back after treatment. Follicular lymphoma is a type of cancer that affects the lymphatic system, which is part of the immune system. This study is important because it explores new treatment possibilities for patients whose cancer does not respond to standard therapies, aiming to improve their chances of recovery and extend survival. Participants in the study receive the treatment directly, as it is an "open-label" study, meaning both doctors and participants know which treatment is being administered. Researchers will assess how well the treatment works by looking at factors such as complete response, overall survival rates, and how long patients live without the disease getting worse. Any side effects from the treatment will also be closely monitored to ensure the safety of the participants. This study does not include a comparison group, so all participants receive the combination of Chidamide and Linperlisib.

Official TitleA Multicenter, Prospective, Single-arm Clinical Study on the Treatment of Refractory/Relapsed Follicular Lymphoma (R/RFL) With Chidamide Combined With Linperlisib

NCT06158386

Principal SponsorThe First Affiliated Hospital of Xiamen University

Study ContactBing XuMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

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

Design Details

33 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Hemic and Lymphatic DiseasesImmune System DiseasesImmunoproliferative DisordersLymphatic DiseasesLymphomaLymphoma, FollicularLymphoma, Non-HodgkinLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypeLymphoma, B-Cell

Criteria

7 inclusion criteria required to participate

The patients diagnosed with follicular lymphoma with grade 1-3a, have received at least second-line systemic treatment, and at least one of the first-line treatments includes anti-CD20 monoclonal antibody (anti-CD20 monoclonal antibody monotherapy or combined chemotherapy). If the latest histopathological diagnosis is more than 6 months, a lymph node or tissue puncture or biopsy (resection or coarse needle puncture) must be performed.

Age ≥18 years old, regardless of gender.

The estimated survival time is more than 3 months.

ECOG ≤ 2.

Show More Criteria

21 exclusion criteria prevent from participating

CNS involvement (current or previous).

Clinical evidence of transformation to a more aggressive subtype of lymphoma

Impaired bone marrow function: neutrophils < 1.5× 10*9/L, HB < 80 g/L, PLT < 75×10*9 /L, Impaired liver function, defined as serum total bilirubin > 1.5 x ULN or serum ALT and AST > 2.5x ULN, Patients with liver infiltration by lymphoma, AST and ALT > 5x ULN, Renal glomerular filtration rate (eGFR) < 30 ml/min.

PT INR>1.5ULN or APTT> 1.5 ULN, Serum amylase or lipase > 1ULN.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Bing Xu

Xiamen, ChinaOpen Bing Xu in Google Maps

Recruiting

One Study Center