RecruitingPhase 3NCT06947967

Tucidinostat in Combination With CHOP in Newly Diagnosed Peripheral T-Cell Lymphoma With Follicular Helper of T Cell Phenotype

A Phase III, Randomised, Double-blind, Placebo-controlled, Multicenter Study of Tucidinostat in Combination With CHOP in Newly Diagnosed Peripheral T-Cell Lymphoma With Follicular Helper of T Cell Phenotype (SWIFT 02)


Sponsor

Chipscreen Biosciences, Ltd.

Enrollment

224 participants

Start Date

Aug 12, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

A Randomised, Double-blind, Multicenter Phase Ⅲ Study to Evaluate the Efficacy and Safety of Tucidinostat versus Placebo in Combination with CHOP in Newly Diagnosed Peripheral T-Cell Lymphoma with Follicular Helper of T Cell Phenotype


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a drug called tucidinostat (a type of HDAC inhibitor that affects how cancer genes are turned on and off) to standard CHOP chemotherapy improves outcomes for people newly diagnosed with a specific subtype of T-cell lymphoma called peripheral T-cell lymphoma with follicular helper T-cell phenotype (PTCL-TFH). **You may be eligible if...** - You are between 18 and 80 years old - You have been newly diagnosed with PTCL-TFH (including angioimmunoblastic T-cell lymphoma or follicular helper T-cell lymphoma) confirmed by biopsy - You have not yet received any treatment for this lymphoma - You are in reasonably good physical condition (ECOG 0–2) - You have at least one measurable tumor on imaging **You may NOT be eligible if...** - You have already received treatment for this lymphoma - You have another active cancer - Your blood counts or organ function are too low for chemotherapy - You have active infections or severe heart conditions 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

DRUGCHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone)

Cyclophosphamide 750 mg/m2 , intravenous infusion on day 1 of each 21-day cycle. Doxorubicin 70mg/m2 , intravenous infusion on day 1 of each 21-day cycle, total 6 cycles. Vincristine 1.4mg/m2(Max dose 2mg), intravenous injection on day 1 of each 21-day cycle , total 6 cycles. Prednisone 100 mg, oral, day 1-5 of each 21-day cycle,total 6 cycles.

DRUGTucidinostat

oral, taking as prescribed by the protocol

DRUGPlacebo

oral, taking as prescribed by the protocol


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

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NCT06947967


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