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Tucidinostat in Combination With CHOP in Newly Diagnosed Peripheral T-Cell Lymphoma With Follicular Helper of T Cell Phenotype | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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)

NCT06947967•Chipscreen Biosciences, Ltd.

View on ClinicalTrials.gov

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

Detailed Description

This is 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.Participants Will be Randomised (1:1) to ReceiveTucidinostat (Experimental Arm) or Placebo(Control Arm)in Combination with CHOP .

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Provide written informed consent for the study.
•2. Male or female, age ≥ 18 years and ≤80 years.
•3. ECOG PS 0,1 or 2.
•4. Participants with histologically proven peripheral T-cell lymphoma with T-follicular helper phenotype (PTCL-TFH), including: a. angioimmunoblastic T-cell lymphoma, b. follicular helper T-cell lymphoma, follicular type, c. follicular helper T-cell lymphoma, NOS.
•5. At least one measurable disease according to the Lugano 2014 Classification.
•6. Laboratory criteria are as follows except that caused by lymphoma assessed by the investigator (without receiving any supportive treatment for the following parameters within 2 weeks from the last dose prior to study entry):
•(1)Hematology values:Hemoglobin (Hb)≥90g/L,Absolute neutrophil count (ANC) ≥1.5×10 9/L, platelets ≥90×10 9/L (2)Biochemical values: Serum creatinine ≤1.5×upper limit of normal(ULN),Total bilirubin ≤1.5 × ULN, Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) ≤2.5×ULN(ALT, AST≦5×ULN if liver involved).
•7.Expected survival≥6 months.

Exclusion Criteria

•1. Presence of CNS involvement.
•2. Received prior therapies targeting lymphoma.
•3. Participants planned for autologous or allogeneic transplant as consolidation after CR.
•4. Participants with any other malignancy in past 5 years, except for local tumors that have been cured.
•5. Prior treatment with cytotoxic drugs for another condition (e.g., rheumatoid arthritis).
•6. Any investigational therapy within 3 months.
•7. Contraindication to any of the individual components of CHOP.
•8. Corticosteroid use \> 30 mg/day of prednisone or equivalent, for purposes other than lymphoma symptom control, and the following conditions for inclusion must be met, a. participants receiving corticosteroid treatment with ≤ 30 mg/day of prednisone or equivalent must be documented to be on a stable dose of at least 4 weeks' duration prior to randomization, b. If glucocorticoid treatment is urgently required for lymphoma symptom control prior to the start of study treatment, prednisone 100 mg or equivalent could be given for a maximum of 7 days, but all tumor assessments must be completed prior to start of glucocorticoid treatment.
•9. Ongoing serious central nervous system disease or peripheral neuropathy, such as progressive multifocal leukoencephalopathy.
•10. Have uncontrolled or significant cardiovascular disease, including a. Grade Ⅱ or higher Congestive heart failure, unstable angina pectoris, myocardial infarction (New York Heart Association Functional Classification ) within 6 months prior to study entry; or arrhythmia requiring treatment, or Left Ventricular Ejection Fraction (LVEF) \< 50% during screening stage b.Primary cardiomyopathy (dilated cardiomyopathy, hypertrophic cardiomyocyte, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, et,al) c.History of significant QT interval prolongation, or Corrected QT Interval QTc≥450ms(male), QTc≥470ms（female）at screening d.Symptomatic coronary heart disease requiring treatment e.Any other cardiovascular disease which is inappropriate for the study according to investigators' judgment.
+12 more criteria

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Key Dates

Start Date

August 12, 2025

Primary Completion Date

December 1, 2032

Completion Date

December 1, 2032

Last Updated

September 15, 2025

Enrollment

224

ESTIMATED participants

Conditions

Lymphoma, T-Cell, Peripheral

Interventions

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

DRUG

Tucidinostat

DRUG

Placebo

DRUG

Contacts

Xinhao Wang

CONTACT

+86 0755-36993550 xinhwang@chipscreen.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Soquelitinib vs Standard of Care in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma Not Otherwise Specified, Follicular Helper T-cell Lymphomas, or Systemic Anaplastic Large-cell Lymphoma

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