Tucidinostat, Azacitidine Combined With CHOP Versus CHOP in Patients With Untreated Peripheral T-cell Lymphoma

Study Overview
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Brief Summary
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This is a prospective, multicenter, phase III study of Tucidinostat, Azacitidine combined with CHOP versus CHOP in patients with untreated peripheral T-cell lymphoma

Detailed Description
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Tucidinostat, a novel histone deacetylase inhibitor has been approved for the treatment of relapsed or refractory peripheral T-cell lymphoma in China. Azacytidine is a hypomethylating agent. The aim of this study is to compare the efficacy and safety of azacytidine, tucidinostat combined with CHOP regimen and classical CHOP regimen in the treatment of primary PTCL

Official Title
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A Prospective, Multicenter, Phase III, Non-randomized Study of Tucidinostat, Azacitidine Combined With CHOP Versus CHOP in Patients With Untreated Peripheral T-cell Lymphoma

Conditions
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T-cell Lymphoma

Intervention / Treatment
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* Drug: Tucidinostat, Azacitidine combined with CHOP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with peripheral T-cell lymphoma confirmed by primary pathology; Age 18-70 years; ECOG performance status ≤ 2; Adequate bone marrow hematopoietic function: WBC > 3.5 × 10*9/L，ANC>1.5 × 10*9/L，HGB>90g/L，PLT>80 × 10*9/L; Adequate organ function: cardiac function grade 0-2 (NYHA); SpO2 > 88% (natural condition); ALT<3UNL，TBil<2ULN; SCr>60ml/min/m2; Patients have signed the Informed Consent Form Exclusion Criteria: ALK positive anaplastic T-cell lymphoma; NK / T cell lymphoma, nasal type; Uncontrolled active infection; Acute myocardial infarction or unstable angina pectoris within 6 months; uncontrolled hypertension, symptomatic arrhythmia, etc; Subjects who are known or suspected to be unable to comply with the study protocol; Pregnant or lactating women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tucidinostat, Azacitidine combined with CHOP<br>Tucidinostat, Azacitidine combined with CHOP | Drug: Tucidinostat, Azacitidine combined with CHOP<br>* Azacitidine: 200 mg D1200 mg D2100 mg D3 subcutaneous injection Tucidinostat: 20mg / time, D1, 4, 8, 11; Take medicine with 200ml warm boiled water 30 minutes after breakfast. CHOP chemotherapy: Cyclophosphamide (CTX) 750mg / m2 intravenous infusion, day 1; Epirubicin (EPI) 70mg / m2 intravenous infusion, day 1; Vinoresin (VDS) 4mg intravenous infusion, day 1; Prednisone 100mg orally, day 1-5. Every 21 days is a course of treatment<br>|
| Active Comparator: CHOP<br>CHOP | Drug: Tucidinostat, Azacitidine combined with CHOP<br>* Azacitidine: 200 mg D1200 mg D2100 mg D3 subcutaneous injection Tucidinostat: 20mg / time, D1, 4, 8, 11; Take medicine with 200ml warm boiled water 30 minutes after breakfast. CHOP chemotherapy: Cyclophosphamide (CTX) 750mg / m2 intravenous infusion, day 1; Epirubicin (EPI) 70mg / m2 intravenous infusion, day 1; Vinoresin (VDS) 4mg intravenous infusion, day 1; Prednisone 100mg orally, day 1-5. Every 21 days is a course of treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate (ORR) | the total proportion of patients with complete response (CR) and partial response (PR) | 6 course of treatment (each cycle is 21 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-year progression-free survival（PFS） | Time from treatment until disease progression or death | 2 years | 
| 2-year overall survival（OS） | Time from treatment until death from any cause | 2 years | 
| Incidence and severity of adverse events, serious adverse events and other safety parameters | Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0 | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tucidinostat, Azacitidine, CHOP