Actively Recruiting
Tucidinostat in Combination With CHOP in Newly Diagnosed Peripheral T-Cell Lymphoma With Follicular Helper of T Cell Phenotype
Led by Chipscreen Biosciences, Ltd. · Updated on 2025-09-15
224
Participants Needed
1
Research Sites
381 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Tucidinostat in Combination With CHOP in Newly Diagnosed Peripheral T-Cell Lymphoma With Follicular Helper of T Cell Phenotype
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent for the study.
- Male or female, age 18 years to 80 years.
- ECOG performance status 0, 1, or 2.
- Histologically confirmed peripheral T-cell lymphoma with T-follicular helper phenotype, including angioimmunoblastic T-cell lymphoma, follicular helper T-cell lymphoma (follicular type), or follicular helper T-cell lymphoma, NOS.
- At least one measurable disease by Lugano 2014 Classification.
- Laboratory values within specified ranges (hemoglobin 90 g/L, ANC 1.5 x10 9/L, platelets 90 x10 9/L, creatinine 1.5 x ULN, bilirubin 1.5 x ULN, ALT and AST 2.5 x ULN; ALT and AST 5 x ULN if liver involved) without supportive treatment within 2 weeks prior to study entry.
- Expected survival of at least 6 months.
You will not qualify if you...
- Presence of central nervous system involvement.
- Prior therapies targeting lymphoma.
- Planned autologous or allogeneic transplant as consolidation after complete remission.
- Other malignancy within past 5 years except cured local tumors.
- Prior cytotoxic drug treatment for other conditions.
- Use of investigational therapy within 3 months.
- Contraindications to any CHOP components.
- Corticosteroid use >30 mg/day prednisone or equivalent for non-lymphoma reasons; stable corticosteroid dose 30 mg/day for at least 4 weeks prior to randomization; prednisone 100 mg or equivalent allowed up to 7 days before study start if urgently needed for lymphoma symptoms.
- Serious ongoing central nervous system disease or peripheral neuropathy.
- Uncontrolled or significant cardiovascular disease including heart failure, unstable angina, recent myocardial infarction within 6 months, arrhythmia requiring treatment, low left ventricular ejection fraction, primary cardiomyopathy, history of significant QT prolongation, symptomatic coronary heart disease, or other cardiovascular diseases deemed inappropriate by investigators.
- History or signs of interstitial lung disease.
- Conditions affecting oral medication intake or prior gastrectomy.
- History of deep vein thrombosis or pulmonary embolism.
- Active bleeding within 2 months before first treatment or bleeding risks unless due to lymphoma.
- Major surgery or severe unhealed wounds within 4 weeks; minor surgery within 7 days.
- Active infection requiring systemic treatment within 2 weeks before first dose.
- Positive for hepatitis B or C virus with active replication, active syphilis infection.
- History of HIV or other immunodeficiency, or history of organ or stem cell transplantation.
- Mental or cognitive disorder impairing consent or compliance.
- Drug or alcohol abuse.
- Women of childbearing potential unwilling or unable to use contraception during treatment and for 12 weeks after last dose, and spouses of male participants.
- Any other condition considered inappropriate for the study by investigators.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510050
Actively Recruiting
Research Team
X
Xinhao Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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