RecruitingPhase 3NCT06776952

A Randomized, Double-blind, Multicenter Phase III Study of XNW5004 Tablets in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma


Sponsor

Evopoint Biosciences Inc.

Enrollment

120 participants

Start Date

Apr 10, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a randomized, double-blind, multi-center, phase III clinical trial designed to evaluate the efficacy of XNW5004 tablets versus Chidamide in Relapsed/Refractory PTCL, with a target of enrolling 120 subjects.


Eligibility

Min Age: 18 DaysMax Age: 70 Days

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called XNW5004 in people with peripheral T-cell lymphoma (PTCL) — a type of aggressive blood cancer involving T-cells — whose cancer has come back or stopped responding to previous treatment. XNW5004 belongs to a class of drugs called HDAC inhibitors, which work by altering how cancer cells grow and divide. **You may be eligible if...** - You are between 18 and 70 years old - You have peripheral T-cell lymphoma confirmed by pathology testing - Your cancer has relapsed or is refractory (not responding) after at least one prior treatment - You have not previously received an HDAC inhibitor drug - You have at least one measurable tumor - You are willing to provide tumor tissue samples **You may NOT be eligible if...** - You have previously been treated with an HDAC inhibitor - You have certain subtypes requiring specific prior treatments that you have not received (e.g., NK/T-cell lymphoma without prior asparaginase-based therapy) - Your general health or organ function does not meet required levels Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGXNW5004 ; Chidamide placebo

XNW5004 + Chidamide placebo

DRUGXNW5004 placebo; Chidamide

XNW5004 placebo + Chidamide


Locations(1)

Beijing Friendship Hospital,Capital Medical University

Beijing, Beijing Municipality, China

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NCT06776952


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