RecruitingPhase 2NCT05572983

Phase Ⅱ Study of Chidamide in Combination With CHOP in Previously Untreated Peripheral T-Cell Lymphoma With Follicular Helper of T Cell Phenotype

Phase Ⅱ Study of Chidamide in Combination With CHOP in Previously Untreated Peripheral T-Cell Lymphoma With Follicular Helper of T Cell Phenotype (SWIFT)


Sponsor

Sun Yat-sen University

Enrollment

47 participants

Start Date

Sep 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This is a prospective, open-label, single arm, multicenter clinical study to evaluate the safety, tolerability, efficacy of chidamide in combination with CHOP in previously untreated peripheral T-cell lymphoma with follicular helper of T cell phenotype


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called chidamide (a type of targeted therapy) combined with a standard chemotherapy regimen (CHOP) for people newly diagnosed with a specific type of T-cell lymphoma called peripheral T-cell lymphoma with a follicular helper T-cell pattern. The goal is to see if adding chidamide improves outcomes. **You may be eligible if...** - You are between 18 and 75 years old - You have been newly diagnosed with angioimmunoblastic T-cell lymphoma (AITL), follicular T-cell lymphoma, or related subtypes confirmed by biopsy - You have not yet received any treatment for lymphoma - You have measurable disease on imaging - Your overall health is good enough for chemotherapy **You may NOT be eligible if...** - You have received prior chemotherapy, radiation, or immunotherapy for lymphoma - You are eligible for and willing to undergo stem cell transplant (unless you refuse) - Your organ function does not meet the study requirements 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

DRUGChidamide combined with CHOP

A)Chidamide: 20mg, D1, 4,8,11, po; B) Cyclophosphamide: 750 mg/ m2, D1, iv.drip; C) Doxorubicin: 50 mg/ m2, D1, iv.drip (or epirubicin 70 mg/ m2, D1, iv.drip); D) Vincristine: 1.4 mg/ m2, D1 (maximum dose 2mg, maximum dose 1.5mg for age over 70 years), iv; E) Prednisone: 40mg/m2, D1-5,po

DRUGChidamide

Chidamide: 20mg,qw(d1,d4),po


Locations(1)

Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University

Guangzhou, Guangdong, China

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NCT05572983