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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06776952