NCT06947967
Recruiting
Phase 3
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)
Chipscreen Biosciences, Ltd.1 site in 1 country224 target enrollmentStarted: August 12, 2025Last updated:
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Chipscreen Biosciences, Ltd.
- Enrollment
- 224
- Locations
- 1
- Primary Endpoint
- Progression-Free Survival (PFS)
Overview
Brief 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 .
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Provide written informed consent for the study.
- •Male or female, age ≥ 18 years and ≤80 years.
- •ECOG PS 0,1 or
- •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.
- •At least one measurable disease according to the Lugano 2014 Classification.
- •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
- •Presence of CNS involvement.
- •Received prior therapies targeting lymphoma.
- •Participants planned for autologous or allogeneic transplant as consolidation after CR.
- •Participants with any other malignancy in past 5 years, except for local tumors that have been cured.
- •Prior treatment with cytotoxic drugs for another condition (e.g., rheumatoid arthritis).
- •Any investigational therapy within 3 months.
- •Contraindication to any of the individual components of CHOP.
- •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.
- •Ongoing serious central nervous system disease or peripheral neuropathy, such as progressive multifocal leukoencephalopathy.
- •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.
Arms & Interventions
C-CHOP
Experimental
Intervention: CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone) (Drug)
C-CHOP
Experimental
Intervention: Tucidinostat (Drug)
CHOP
Placebo Comparator
Intervention: CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone) (Drug)
CHOP
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Progression-Free Survival (PFS)
Time Frame: Up to approximately 60 month
Defined as the duration from the date of randomization to the date of progression, relapse from CR, or death, whichever occurred first.
Secondary Outcomes
- Complete Response Rate(CRR)(Up to approximately 36 months)
- Overall response rate (ORR)(Up to approximately 36months)
- Event Free Survival (EFS)(Up to approximately 60 month)
- Disease-Free Survival (DFS)(Up to approximately 60 month)
- Overall Survival (OS)(Up to approximately 60 month)
- Safety and Tolerability(Up to approximately 78 months)
- Plasma concentrations of tucidinostat(Up to approximately 60 month)
Investigators
Study Sites (1)
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