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

NCT06947967 | Recruiting Phase 3 DMC

• 1 other identifier: CDM304
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

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

Conditions

Lymphoma, T-Cell, Peripheral

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  Defined as the duration from the date of randomization to the date of progression, relapse from CR, or death, whichever occurred first.

  Up to approximately 60 month

Secondary Outcomes (7)

• 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

Study Arms (2)

C-CHOP

EXPERIMENTAL

Drug: CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone); Drug: Tucidinostat

CHOP

PLACEBO COMPARATOR

Drug: CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone); Drug: Placebo

Interventions

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

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.

C-CHOP; CHOP

Tucidinostat DRUG

oral, taking as prescribed by the protocol

C-CHOP

Placebo DRUG

oral, taking as prescribed by the protocol

CHOP

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide written informed consent for the study.
• Male or female, age ≥ 18 years and ≤80 years.
• ECOG PS 0,1 or 2.
• 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).
• Expected survival≥6 months.

You may not qualify if:

• 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.
• 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.
• History of interstitial lung disease(ILD), or with ongoing signs and symptoms by CT or MRI at the time of screening.
• Participants with factors that could affect oral medication (such as dysphagia, chronic diarrhea, intestinal obstruction etc), or undergone gastrectomy.
• History of deep vein thrombosis or pulmonary embolism.
• History of active bleeding within 2 months prior to the start of Cycle 1;or participants receiving anticoagulation therapy; or participants with evidence of bleeding potential according to investigators' judgment ( esophageal varices, active ulcer, or fecal occult blood test positive etc. ). participants with bleeding led by lymphoma according to investigators' judgment are eligible.
• Major surgical procedures (craniotomy, thoracotomy, or laparotomy) or severe unhealed wounds, ulcers, or fractures were performed within 4 weeks. Tissue biopsy or other minor surgical procedure (other than venipuncture for intravenous fluids) within 7 days.
• Active infection requiring systemic treatment (oral, intravenous infusion) was present within 2 weeks prior to the first dose. Participants receiving prophylactic antibiotic therapy (e.g., interstitial pneumonia) may be enrolled.

Sponsors & Collaborators

• Chipscreen Biosciences, Ltd.: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510050, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Interventions

Cyclophosphamide; Doxorubicin; Vincristine; Prednisone; N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds

Study Officials

• Qingqing Cai

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xinhao Wang

CONTACT

+86 0755-36993550; xinhwang@chipscreen.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: April 27, 2025
• Study Start: August 12, 2025
• Primary Completion (Estimated): December 1, 2032
• Study Completion (Estimated): December 1, 2032
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)